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Insufficient recruitment and end of funding
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| Name | Class |
|---|---|
| Apos Medical and Sports Technology Ltd. | INDUSTRY |
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AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with knee osteoarthritis since patients with knee osteoarthritis have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee OA, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.
AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). Capitalizing on the reported excellent adherence and clinical benefit of Apos Therapy in patients with significant lower limb arthritis, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in knee OA population.
A potential use of AposTherapy as a replacement for traditional physical therapy may yield a less costly, more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence (patients often do not complete the sessions and have very poor adherence (about 50-60%) to home therapy programs), added cost of travel (which may be more than $100 per session for ambulette or access-a-ride for eligible patients), and the lack of continuation in an ongoing exercise program, leading to relapse and need for retreatment. Additionally, access to physical therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an alternative exercise program that will increase adherence, decrease total therapy visits, and improve patient's outcomes with decreased dependence on pain medications is a high priority from both patient care and cost management perspectives.
AposTherapy potentially overcomes many of these issues with improving/modifying abnormal biomechanics (therefore decreasing pain), and a home-based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This biomechanical approach may significantly reduce pain and improve function in patients with knee OA. Capitalizing on the reported excellent adherence and clinical benefit of AposTherapy in patients with significant knee OA, the investigators propose to evaluate the biomechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement or supplant traditional pain medications, interventional pain procedures and physical therapy in an at-risk urban inner city population with knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Physical Therapy | Active Comparator | Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year. |
|
| AposTherapy | Experimental | Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AposTherapy | Device | AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Pain and Function | Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life by RAND SF-36 (RAND Corporation Short Form 36) | Health-related Quality of Life (QoL) as assessed using the RAND SF-36 (Short Form Health Survey). The RAND SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Composite scoring range is 0 to 100 across the 8 domains identified with a higher overall score defining a more favorable health state. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Bartels, MD, MPH | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17551881 | Background | Jones KR, Vojir CP, Hutt E, Fink R. Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents. J Rehabil Res Dev. 2007;44(2):305-14. doi: 10.1682/jrrd.2006.05.0051. | |
| 12456852 | Background | Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8. doi: 10.1056/NEJMoa020441. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional Physical Therapy | Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year. Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy |
| FG001 | AposTherapy | Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year. AposTherapy: AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional Physical Therapy | Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year. Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy |
| 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 | Knee Pain and Function | Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain. | STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
1 year
No active intervention, only follow-up
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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 | Traditional Physical Therapy | Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year. Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Bartels | Montefiore Medical Center | (914) 597-2332 | MBARTELS@montefiore.org |
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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 | Jul 26, 2018 | Mar 17, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
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The outcomes assessor is the only one masked in the study. Assessor is independent of the randomization, trial coordination, and care providers.
| Traditional Physical Therapy | Other | Up to 20 sessions of traditional physical therapy |
|
| 24 weeks |
| PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | Pain and Function measured through PROMIS short forms. PROMIS measures specific domains of Physical Health (e.g., physical function, pain intensity, pain interference, fatigue, sleep disturbance); Mental Health (depressive symptoms, anxiety, anger); and Social Health (ability to participate in social roles and activities). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS domains use different terms to describe score ranges. For example, some domains use mild/moderate/severe whereas others use very high to very low. Cut points for assessment can also vary. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average referenced population. This could be a desirable or undesirable outcome. | 24 weeks |
| Gait Assessment | Objective assessment of the patients' gait assessed with gait analysis equipment. Equipment was used to measure the patients' cadence, or walking rate, in number of steps per minute (steps/min). | 24 weeks |
| 6-min Walk Test | objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course | 24 weeks |
| 24383821 | Background | Elbaz A, Mor A, Segal G, Aloni Y, Teo YH, Teo YS, Das-De S, Yeo SJ. Patients with knee osteoarthritis demonstrate improved gait pattern and reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre study on Singaporean population. J Orthop Surg Res. 2014 Jan 2;9:1. doi: 10.1186/1749-799X-9-1. |
| 23273535 | Background | Haim A, Segal G, Elbaz A, Mor A, Agar G, Bar-Ziv Y, Beer Y, Morag G, Debi R, Atoun E. The outcome of a novel biomechanical therapy for patients suffering from anterior knee pain. Knee. 2013 Dec;20(6):595-9. doi: 10.1016/j.knee.2012.11.009. Epub 2012 Dec 27. |
| 22521468 | Background | Drexler M, Elbaz A, Mor A, Debi R, Debbi EM, Haim A, Lador R, Salai M, Segal G. Effects of a customized biomechanical therapy on patients with medial compartment knee osteoarthritis. Ann Phys Rehabil Med. 2012 May;55(4):213-28. doi: 10.1016/j.rehab.2012.01.002. Epub 2012 Mar 27. English, French. |
| 23692690 | Background | Segal G, Bar-Ziv Y, Velkes S, Benkovich V, Stanger G, Debbi EM, Debi R, Mor A, Elbaz A. A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg Res. 2013 May 21;8:13. doi: 10.1186/1749-799X-8-13. |
| 16506876 | Background | Forkan R, Pumper B, Smyth N, Wirkkala H, Ciol MA, Shumway-Cook A. Exercise adherence following physical therapy intervention in older adults with impaired balance. Phys Ther. 2006 Mar;86(3):401-10. |
| 24369076 | Background | Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189. |
| 23313532 | Background | Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8. |
| 25952351 | Background | Fitzgerald GK, Hinman RS, Zeni J Jr, Risberg MA, Snyder-Mackler L, Bennell KL. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):803-14. doi: 10.1016/j.joca.2015.03.013. |
| 18576289 | Background | Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823. |
| 23828186 | Background | Tanaka R, Ozawa J, Kito N, Moriyama H. Efficacy of strengthening or aerobic exercise on pain relief in people with knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2013 Dec;27(12):1059-71. doi: 10.1177/0269215513488898. Epub 2013 Jul 4. |
| 25937024 | Background | Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30. |
| BG001 | AposTherapy | Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year. AposTherapy: AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Traditional Physical Therapy | Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year. Traditional Physical Therapy: Up to 20 sessions of traditional physical therapy |
| OG001 | AposTherapy | Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year. AposTherapy: AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). |
|
|
| Secondary | Quality of Life by RAND SF-36 (RAND Corporation Short Form 36) | Health-related Quality of Life (QoL) as assessed using the RAND SF-36 (Short Form Health Survey). The RAND SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Composite scoring range is 0 to 100 across the 8 domains identified with a higher overall score defining a more favorable health state. | STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed | Posted | Mean | Standard Deviation | score on a scale | 24 weeks |
|
|
|
| Secondary | PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function | Pain and Function measured through PROMIS short forms. PROMIS measures specific domains of Physical Health (e.g., physical function, pain intensity, pain interference, fatigue, sleep disturbance); Mental Health (depressive symptoms, anxiety, anger); and Social Health (ability to participate in social roles and activities). PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS domains use different terms to describe score ranges. For example, some domains use mild/moderate/severe whereas others use very high to very low. Cut points for assessment can also vary. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one SD above the average referenced population. This could be a desirable or undesirable outcome. | STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. The framework initially placed in the Statistical Analysis section has been removed. Analysis of individuals complete at 24 weeks. Only subjects with 24 week data were analyzed. | Posted | Mean | Standard Deviation | T-score | 24 weeks |
|
|
|
| Secondary | Gait Assessment | Objective assessment of the patients' gait assessed with gait analysis equipment. Equipment was used to measure the patients' cadence, or walking rate, in number of steps per minute (steps/min). | STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. Data presented is for patients who completed 24 weeks of the study. Data reported is only on those who entered the study and not outcomes data. Cadence is in steps per minute as entered below. As an example, typical marching is at 120 steps per minute. | Posted | Mean | Standard Deviation | Cadence (steps/minute) | 24 weeks |
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|
|
| Secondary | 6-min Walk Test | objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course | STUDY DISCONTINUED, statistical analysis was not performed due to study closure, not enough participants to conduct meaningful statistical analyses. | Posted | Mean | Standard Deviation | Feet | 24 weeks |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 5 |
| 17 |
| EG001 | AposTherapy | Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year. AposTherapy: AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). | 0 | 37 | 0 | 37 | 10 | 37 |
| Leg Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Back Pain | Nervous system disorders | Non-systematic Assessment |
|
| Inguinal hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Earache | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hyperkalemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Small Bowel Obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Umbilical hernia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cervical spondylosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Lower Extemity Weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hypertension | Cardiac disorders | Non-systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |