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| ID | Type | Description | Link |
|---|---|---|---|
| R21HD086644-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis (OA). Effective treatment of PAHD is needed to improve function in the young adult and prevent or delay the onset of hip OA, however evidence related to treatment of PAHD is limited. This research will provide the foundation for a future clinical trial to assess the efficacy of movement pattern training, an innovative rehabilitation approach for the treatment of PAHD.
Significance: Intra-articular, prearthritic hip disorders (PAHD) result in substantial dysfunction in young adults and are proposed precursors to hip osteoarthritis. The number of surgical procedures to treat PAHD has grown exponentially in the past decade, despite the lack of high level evidence to guide treatment decisions. The potential exists for surgery to become standard treatment before rigorous investigation of treatment options has been completed. This trend may be partially due to a lack of evidence related to rehabilitation. Although some authors believe rehabilitation can improve function in people with PAHD, others state that rehabilitation is contra-indicated and recommend surgery as the best option. There are no published clinical trials to support or refute either opinion, therefore little is known about the comparative effectiveness of rehabilitation.
Innovation: The investigators' long term goal is to develop effective treatment strategies for people with PAHD that will improve function and prevent or delay the onset of OA. Movement pattern training is an innovative rehabilitation approach designed to reduce stresses on the hip joint by optimizing the biomechanics of functional tasks through task-specific instruction. Preliminary work suggests that abnormal movement patterns may be associated with PAHD and that movement pattern training may be an effective treatment approach, however comparison to standard rehabilitation has not been completed.
Purpose: This study was designed to assess the feasibility of conducting a multicenter randomized clinical trial (RCT) to determine the efficacy of movement pattern training compared to standard rehabilitation for people with PAHD. Participants enrolled at Washington University and University of Pittsburgh will be randomized into one of two treatment groups, movement pattern training or standard rehabilitation. In addition to assessing feasibility of the trial, preliminary estimates of effect sizes for treatment outcomes will be obtain in preparation for the future definitive trial. Post-treatment improvements in patient-reported function as measured by the Hip disability and Osteoarthritis Outcome Score and hip adduction motion during functional tasks, a proposed mechanistic factor associated with PAHD will be assessed. Upon completion of this study, the investigators will be positioned to implement a multicenter RCT to definitively assess the efficacy of movement pattern training.
Impact: Ultimately, if movement pattern training is determined to be effective, it will provide a relatively inexpensive alternative to surgical intervention. Further, the theoretical concepts of movement pattern training could be used to possibly serve a role in injury prevention, as well as optimize post-surgical outcomes in those who do require surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Movement Pattern Training (MPT) | Experimental | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. |
|
| Standard Rehabilitation | Active Comparator | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rehabilitation | Other | Comparison of two rehabilitation approaches |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Are Adherent to Treatment Attendance | Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions. | Immediately after treatment (13 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activities in Daily Living subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Activities in Daily Living from the post-treatment HOOS Activities in Daily Living . |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Pain from the post-treatment HOOS Pain. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcie Harris-Hayes, DPT, MSCI | Washington University School of Medicine | Principal Investigator |
| Kelley Fitzgerald, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Program in Physical Therapy, Washington University | St Louis | Missouri | 63108 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Harris-Hayes M, Steger-May K, Bove A, Foster S, Mueller MJ, Clohisy JC, Fitzgerald GK. Sustained Outcomes Following Movement Pattern Training or Strengthening/Flexibility Among Patients with Prearthritic Hip Disorders: Results of a Pilot Multicenter Randomized Clinical Trial. Accepted for OARSI World Congress on Osteoarthritis, April 2020. | ||
| 33291065 | Background | Foster SN, Harris MD, Hastings MK, Mueller MJ, Salsich GB, Harris-Hayes M. Static Ankle Dorsiflexion and Hip and Pelvis Kinematics During Forward Step-Down in Patients With Hip-Related Groin Pain. J Sport Rehabil. 2020 Dec 8;30(4):638-645. doi: 10.1123/jsr.2020-0140. | |
| 34370330 |
| Label | URL |
|---|---|
| Rehabilitation Research for Orthopaedic Conditions (RROC) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Movement Pattern Training (MPT) | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. Rehabilitation: Comparison of two rehabilitation approaches |
| FG001 | Standard Rehabilitation | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. Rehabilitation: Comparison of two rehabilitation approaches |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Movement Pattern Training (MPT) | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. Rehabilitation: Comparison of two rehabilitation approaches |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Are Adherent to Treatment Attendance | Percentage of study participants who attend 90% (9/10) of the supervised treatment sessions. | Posted | Count of Participants | Participants | Immediately after treatment (13 weeks after baseline) |
|
Adverse events were monitored from baseline assessment to final data collection which occurred 12 months after treatment completion.
Our definitions of adverse events were the same as those from clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Movement Pattern Training (MPT) | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. Movement Pattern Training (MPT) will focus on task-specific training to improve lower extremity movement patterns during basic tasks, such as sit to stand and stairs, and reported patient-specific tasks. Patient education will include instruction in abnormal movement patterns and methods to optimize movement patterns during each task. Exercises will include repeated practice of tasks using optimized movement patterns. Verbal cues and visual aids will be used to assist the participant. Difficulty of the task-specific activities will be progressed by varying repetitions performed, increasing load or changing the support surface. Rehabilitation: Comparison of two rehabilitation approaches |
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This is a pilot study to determine preliminary estimates of treatment effects for movement pattern training and standard rehabilitation. We cannot make definitive statements regarding efficacy of Movement Pattern Training or Standard treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marcie Harris-Hayes, PT, DPT, MSCI, Professor, Physical Therapy and Orthopaedic Surgery | Washington University School of Medicine | 314-286-1435 | harrisma@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2016 | Apr 14, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057925 | Femoracetabular Impingement |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D026741 | Physical Therapy Modalities |
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Immediately after treatment (13 weeks after baseline) |
| Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOSSymptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptoms from the post-treatment HOOSSymptoms. | Immediately after treatment (13 weeks after baseline) |
| Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Sport from the post-treatment HOOS Sport. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Quality of Life (QOL) Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Quality of Life from the post-treatment HOOS Quality of Life. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks) | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the post-treatment PSFS. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the post-treatment average NPRS. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the post-treatment worst NPRS. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 6 month HOOSADL. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 6 month HOOSSymptom. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 6 month HOOSPain. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSPort from the 6 month HOOSSport. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 6 month HOOSQOL. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Patient Specific Functional Scale From Baseline to 6 Months After Treatment Completion. | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 6 month PSFS. | Between Baseline and 6 months after treatment completion |
| Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 6 month average NPRS. | Between Baseline and 6 months after treatment completion |
| Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 6 month worst NPRS. | Between Baseline and 6 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 12 month HOOSADL. | Between 12 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptom Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptom subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 12 month HOOSSymptom. | Between Baseline and 12 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 12 month HOOSPain. | Between Baseline and 12 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSport from the 12 month HOOSSport. | Between Baseline and 12 months after treatment completion |
| Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 12 month HOOSQOL. | Between Baseline and 12 months after treatment completion |
| Change in Function Using the Patient Specific Functional Scale From Baseline to 12 Months After Treatment Completion. | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 12 month PSFS. | Between Baseline and 12 months after treatment completion |
| Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 12 month average NPRS. | between Baseline and 12 months after treatment completion |
| Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 12 month worst NPRS. | Between Baseline and 12 months after treatment completion |
| Change in Glutueus Minimus Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus minimus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Gluteus Minimus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Gluteus Medius Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus medius muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Gluteus Maximus Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus maximus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Gluteus Medius Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Change in Gluteus Maximus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Between Baseline and Immediately after treatment (13 weeks after baseline) |
| Pittsburgh |
| Pennsylvania |
| 15219 |
| United States |
| Result |
| Koch K, Semciw AI, Commean PK, Hillen TJ, Fitzgerald GK, Clohisy JC, Harris-Hayes M. Comparison between movement pattern training and strengthening on muscle volume, muscle fat, and strength in patients with hip-related groin pain: An exploratory analysis. J Orthop Res. 2022 Jun;40(6):1375-1386. doi: 10.1002/jor.25158. Epub 2021 Aug 18. |
| 33458839 | Result | Harris-Hayes M, Steger-May K, M Bove A, Mueller MJ, Clohisy JC, Fitzgerald GK. One-year outcomes following physical therapist-led intervention for chronic hip-related groin pain: Ancillary analysis of a pilot multicenter randomized clinical trial. J Orthop Res. 2021 Nov;39(11):2409-2418. doi: 10.1002/jor.24985. Epub 2021 Mar 2. |
| 32518674 | Result | Harris-Hayes M, Steger-May K, Bove AM, Foster SN, Mueller MJ, Clohisy JC, Fitzgerald GK. Movement pattern training compared with standard strengthening and flexibility among patients with hip-related groin pain: results of a pilot multicentre randomised clinical trial. BMJ Open Sport Exerc Med. 2020 Mar 23;6(1):e000707. doi: 10.1136/bmjsem-2019-000707. eCollection 2020. |
| BG001 | Standard Rehabilitation | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. Rehabilitation: Comparison of two rehabilitation approaches |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Count of Participants | Participants |
|
| Measured BMI | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Mean | Standard Deviation | Kg/m^2 |
|
| OG001 | Standard Rehabilitation | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. Rehabilitation: Comparison of two rehabilitation approaches |
|
|
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| Secondary | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Activities in Daily Living Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activities in Daily Living subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Activities in Daily Living from the post-treatment HOOS Activities in Daily Living . | Posted | Mean | Standard Deviation | units on a scale | Immediately after treatment (13 weeks after baseline) |
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| Secondary | Change in Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOSSymptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptoms from the post-treatment HOOSSymptoms. | Posted | Mean | Standard Deviation | units on a scale | Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Pain from the post-treatment HOOS Pain. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Sport from the post-treatment HOOS Sport. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Quality of Life (QOL) Subscale From Baseline to Post-treatment (13 Weeks) | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOS Quality of Life from the post-treatment HOOS Quality of Life. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Function Using the Patient Specific Functional Scale From Baseline to Post-treatment (13 Weeks) | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the post-treatment PSFS. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the post-treatment average NPRS. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to Post-treatment (13 Weeks) | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the post-treatment worst NPRS. | One participant in the Movement Pattern group withdrew due to time constraints. Three participants in the Standard group withdrew: 1 due to time constraints and 2 were unable to be located. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 6 month HOOSADL. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptoms Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptoms subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 6 month HOOSSymptom. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 6 month HOOSPain. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSPort from the 6 month HOOSSport. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 6 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 6 month HOOSQOL. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Patient Specific Functional Scale From Baseline to 6 Months After Treatment Completion. | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 6 month PSFS. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 6 month average NPRS. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 6 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 6 month worst NPRS. | Six participants, three in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 6 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Activity Daily Living (ADL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSADL from the 12 month HOOSADL. | Eight participants, four in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between 12 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Symptom Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Symptom subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSymptom from the 12 month HOOSSymptom. | Eight participants, four in each arm, were lost to followup. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Pain subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSPain from the 12 month HOOSPain. | Eight participants, four in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) Sport Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Sport subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSSport from the 12 month HOOSSport. | Eight participants, four in each arm, were lost to followup. One participant in the Standard arm did not complete the HOOS Sport subscale at 12 months. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Hip Disability and Osteoarthritis Outcome Score (HOOS) QOL Subscale From Baseline to 12 Months After Treatment Completion. | The Hip disability and Osteoarthritis Outcome Score (HOOS) is a patient reported outcome measure to quantify activity limitations due to hip pain. The outcome reported is the change (improvement) in function using the HOOS Quality of Life (QOL) subscale. Scoring of each subscale ranges from 0-100, with lower scores indicating greater impairment or activity limitation. Change was calculated by subtracting the baseline HOOSQOL from the 12 month HOOSQOL. | Eight participants, four in each arm, were lost to followup. One participant in the Standard arm did not complete the HOOS QOL subscale at 12 months. | Posted | Mean | Standard Deviation | score on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Function Using the Patient Specific Functional Scale From Baseline to 12 Months After Treatment Completion. | The Patient Specific Functional Scale (PSFS), a patient-reported outcome measure of patient-specific activity limitations. Patients are asked to identify "3-5 activities you are unable to do or having difficulties performing due to the pain or symptoms in your hip". Patients then rated level of difficulty from 0-10, 0 indicating they are unable to perform the activity and 10 indicating they are able to perform the activity at their preinjury level. The final score is an average of all scores provided. Change was calculated by subtracting the baseline PSFS from the 12 month PSFS. | Eight participants, four in each arm, were lost to followup. One participant in the Standard arm did not complete the PSFS at 12 months. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Average Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For average NPRS, patients are asked to rate what their pain was over the last week. Change was calculated by subtracting the baseline average NPRS from the 12 month average NPRS. | Eight participants, four in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Worst Pain Intensity Quantified by a Numeric Pain Rating Scale (NPRS) From Baseline to 12 Months After Treatment Completion. | The numeric pain rating scale (NPRS) is a patient-reported outcome measure of pain intensity quantified using a 0-10 scale, 0 indicating the patient perceives no pain and 10 indicating the patient perceives the pain to be "worst pain imaginable". For worst NPRS, patients are asked to rate what was their worst (highest) level of pain was over the last week. Change was calculated by subtracting the baseline worst NPRS from the 12 month worst NPRS. | Eight participants, four in each arm, were lost to followup. | Posted | Mean | Standard Deviation | units on a scale | Between Baseline and 12 months after treatment completion |
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| Other Pre-specified | Change in Glutueus Minimus Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus minimus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | This study was a planned secondary analysis using imaging data that was collected at one of the testing site, Washington University Physical Therapy. Imaging data (MRI) was collected from 27 of the 30 participants enrolled at Washington University site. MRI was not available for one participant who did not tolerate the MRI, and MRI data for two participants were excluded due to poor quality scans. Funding for the imaging was provided by the Foundation for Physical Therapy Research. | Posted | Mean | Standard Deviation | cm^3 | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Gluteus Minimus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Not Posted | Between Baseline and Immediately after treatment (13 weeks after baseline) | Participants |
| Other Pre-specified | Change in Gluteus Medius Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus medius muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | This study was a planned secondary analysis using imaging data that was collected at one of the testing site, Washington University Physical Therapy. Imaging data (MRI) was collected from 27 of the 30 participants enrolled at Washington University site. MRI was not available for one participant who did not tolerate the MRI, and MRI data for two participants were excluded due to poor quality scans. Funding for the imaging was provided by the Foundation for Physical Therapy Research. | Posted | Mean | Standard Deviation | cm^3 | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Gluteus Maximus Muscle Volume From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (increase) in gluteus maximus muscle volume measured in centimeters cubed, using magnetic resonance imaging. Positive scores indicate an increase in volume. Change was calculated by subtracting the baseline muscle volume from the post-treatment muscle volume. | This study was a planned secondary analysis using imaging data that was collected at one of the testing site, Washington University Physical Therapy. Imaging data (MRI) was collected from 27 of the 30 participants enrolled at Washington University site. MRI was not available for one participant who did not tolerate the MRI, and MRI data for two participants were excluded due to poor quality scans. Funding for the imaging was provided by the Foundation for Physical Therapy Research. | Posted | Mean | Standard Deviation | cm^3 | Between Baseline and Immediately after treatment (13 weeks after baseline) |
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| Other Pre-specified | Change in Gluteus Medius Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Not Posted | Between Baseline and Immediately after treatment (13 weeks after baseline) | Participants |
| Other Pre-specified | Change in Gluteus Maximus Muscle Fatty Infiltration From Baseline to Post-treatment (13 Weeks) | The outcome reported is the change (decrease) in the proportion of fatty infiltration within the gluteus maximus muscle, measured by magnetic resonance imaging. A muscle fat index (MFI) was calculated to represent the proportion of fat within a muscle. To be able to analyze fat across the entire length of the muscle (from proximal to distal), muscle length was normalized so that 0% represented the most proximal slice and 100% represented the most distal slice. Mean MFI within every slice was then represented at every 1% of muscle length using spline interpolation. | Not Posted | Between Baseline and Immediately after treatment (13 weeks after baseline) | Participants |
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Standard Rehabilitation | Treatment: 10 sessions over 12 weeks and a home program provided by a physical therapist. Treatment includes assessment of patient goals and patient education. For the Standard Rehabilitation, focus will be on progressive lower extremity and trunk strengthening and lower extremity flexibility. Patient education will include instruction to modify intensity, frequency or duration of patient-specific tasks. Using current clinical practice guidelines and previous reports, strengthening and flexibility exercises will be prescribed and progressed by varying the repetitions performed or increasing the load. Rehabilitation: Comparison of two rehabilitation approaches | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.
The purpose of this study was to determine preliminary estimates of the effect of movement pattern training and standard rehabilitation on patient-reported function.