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| ID | Type | Description | Link |
|---|---|---|---|
| HT9425-25-1-0625 | Other Grant/Funding Number | Department of Defense |
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The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture. Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical performance, and patient reported outcomes. The main questions it aims to answer are:
Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power.
Primary hypothesis: an ankle muscle power program will have acceptable feasibility through assessment of 80% adherence, 90% treatment fidelity, recruitment (48 participants who complete the study), 80% retention, and 80% acceptability of the AMP program to facilitate clinical translation and the ability to scale-up the treatment. In addition ankle plantar flexor muscle power, plantar flexor RTD assessed isometrically, and ankle joint power, evaluated during gait and stair ascent/descent, will have significantly greater improvements in the AMP group than the standard of care group at the end of the intervention.
Test the effect of the AMP program on physical performance. Primary hypothesis: those completing the AMP program will have greater improvements in the 40 meter fast paced walk test and 11-stair climb test than those completing standard of care at the completion of the intervention.
Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life.
Primary hypothesis: compared to standard of care, the AMP program will result in improved quality of life on the ankle fracture outcome rehabilitation measure (A-FORM)
Participants will complete rehabilitation and be assessed for outcomes at baseline and after completing the intervention. Additionally exploratory outcomes will be assessed 3 months after completing the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ankle Muscle Power (AMP) program + standard of care | Experimental | Participants will receive standard of care rehabilitation as needed and directed by the treating physical therapist. Participants will have additional exercises included to facilitate the development of power that will progress as participants move through the rehabilitation program. The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and will have visits for up to 12 weeks with an average of 3 visits per week. |
|
| Standard of care only | Active Comparator | Standard of care rehabilitation includes range of motion, foundational strength exercises, and other modalities (i.e., icing and or low grade NMES) as needed and directed by the treating physical therapist. The intervention may begin approximately 12 weeks post op ± 2 weeks following fixation surgery and rehabilitation will take place for up to 12 weeks with visits occurring 3 times per week on average. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle Muscle Power (AMP) program | Other | The AMP program targets various aspects of muscle power development through a program that takes the participant through 3 different stages of training over the course of their rehabilitation. This portion of the program is in addition to receiving standard rehabilitation exercises as well. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Adhering to the Intervention | Adherence refers to the commitment of a participant to participate in the rehab. Adherence will be measured by calculating the number of rehab sessions attended divided by the number of rehab sessions possible. | From baseline assessment to completion of the 10 week intervention. |
| Percentage of Treatment That is Able to be Delivered (Fidelity) | Fidelity refers to the ability to perform the protocol as intended and that the participants receive the intended treatment as designed. It will be calculated as the number of deviations from protocol divided by the number of treatment sessions. | From baseline assessment to completion of the 10 week intervention. |
| Percentage of Participants Completing the Intervention (Retention) | This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention. | From baseline assessment to completion of the 10 week intervention. |
| Percentage of Participants Who Find the Program Acceptable/Satisfactory | A participant satisfaction survey will be utilized to evaluate each rehabilitation protocol, care given, and rehab facility procedures. Scores will range from 1 to 5 with 1 indicating poor performance of the facility and care received versus 5 indicating excellent performance of the facility and care received. | From baseline assessment to completion of the 10 week intervention. |
| Change in Isometric Ankle Plantar Flexor Muscle Power | Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up | Baseline assessment and post intervention visit (10-12 weeks following baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Usual Gait Speed | Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded. | Baseline and post intervention (10-12 weeks following baseline) |
| Change in Fastest Gait Speed |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brief Pain Inventory (BPI) | This patient reported outcome measures assesses pain severity and interference. Scores range from 0-10 for each subscale of pain/severity or interference/impact with higher scores indicating greater pain severity and impact of pain. Scores can be compared to norms to determine if pain is considered significant. | Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Associate Senior | Contact | 859-323-5438 | delong2@uky.edu | |
| Principal Investigator | Contact | 859-323-1100 | b.noehren@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
The dissemination plan emphasizes transparency of the study, and as a study team, the investigators are committed to sharing de-identified data for external researchers.
IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for mid 2029.
Any external researcher will be able to access de-identified, non-PHI, individual participant data as part of the journal's supplementary information.
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000249 | Adenosine Monophosphate |
| D026741 | Physical Therapy Modalities |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Standard of Care | Behavioral | Standard rehabilitation program |
|
| Change in Ankle Rate of Torque Development (Ankle RTD) | Will be assessed isometrically on a dynamometer as the change between baseline and post-intervention follow-up. Ankle RTD is calculated as the initial slope of the generated force curve, measured in Newton meters per second. | Baseline assessment and post intervention visit (10-12 weeks following baseline) |
| Change in Ankle Joint Power During Gait | Ankle joint power measured with 3D motion capture during walking | Baseline and post intervention (10-12 weeks following baseline) |
| Change in Ankle Joint Power During Stairs (step up and down) | Ankle joint power measured with 3D motion capture while climbing stairs | Baseline and post intervention (10-12 weeks following baseline) |
Participants will walk at their fastest comfortable speed with the time to complete 5 meters recored.
| Baseline and following completion of the intervention (10-12 weeks post baseline visit) |
| Change in 11 Stair Climb Test Score | The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps (11). Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance. | Baseline visit and post intervention visit (10-12 weeks post baseline) |
| Change in Ankle fracture outcome rehabilitation measure (A-FORM) | The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is a patient-reported outcome measure designed to assess recovery after an ankle fracture. It focuses on physical, social, and psychological aspects of recovery. A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes. | Baseline and post intervention (10-12 weeks following baseline) |
| Change in PROMIS Physical Function Computer Adaptive Test | The PROMIS Physical Function computer adaptive test will be administered to each subject. Scale 0-100, where higher numbers indicate better physical functioning. A score of 50 is consistent with the mean score of the U.S. general population. | Baseline assessment and post intervention visit (10-12 weeks later) |
| Change in Tampa Scale of Kinesiophobia (TSK) | A patient reported outcome measures that assesses fear of movement due to pain. The full TSK (17-item) yields a total score between 17 and 68, where higher scores indicate greater kinesiophobia. | Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention. |
| Ankle Plantar Flexor muscle cross sectional area | The cross sectional area of the gastrocnemius muscle will be evaluated using ultrasound imaging. The area of the muscle will be measured in cm squared. | Baseline and post intervention (10-12 weeks following the baseline visit) |
| Change in the Work Productivity and Activity Impairment Questionnaire (WPAI) | A patient reported outcome measures that assesses impairments in work productivity following an injury. The WPAI questionnaire yields four scores; absenteeism, presenteeism, overall work impairment, and activity impairment which are expressed as percentages. Absenteeism is calculated as hours missed divided by total hours available for work. Presenteeism is derived from the 0-10 scale measuring health's impact on productivity while working. Overall work impairment combines both, and activity impairment measures health's effect on non-work tasks. Higher percentage scores indicate greater impairment and reduced productivity. | Baseline, following the intervention (10-12 weeks post intervention) and at a 3 month follow up after completing the intervention. |
| Change in Ankle fracture outcome rehabilitation measure (A-FORM)-midpoint | A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes. The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is a patient-reported outcome measure designed to assess recovery after an ankle fracture. It focuses on physical, social, and psychological aspects of recovery. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in Fastest Gait Speed-midpoint | Participants will walk at their fastest comfortable speed with the time to complete 5 meters recorded. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in Usual Gait Speed-midpoint | Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in 11 Stair Climb Test Score-midpoint | The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps. Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in Isometric Ankle Plantar Flexor Muscle Power- mid point | Will be assessed isotonically on a dynamometer as the peak power. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in Ankle Rate of Torque Development (Ankle RTD)-midpoint | Will be assessed isometrically on a dynamometer as the slope of the generated force curve. It is the peak rate of force development measured in Newton meters per second. | After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op) |
| Change in Ankle Hindfoot Scale (AOFAS) | The AOFAS Ankle-Hindfoot Scale is a short survey and exam that looks at ankle and foot problems. It measures three main things: pain, how well a person can move and do daily activities, and how well the ankle and foot are lined up. The score goes from 0 to 100, with higher scores meaning less pain and better function. It helps doctors and researchers track recovery and compare treatments. | Baseline assessment and post intervention visit (10-12 weeks following baseline) |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |