Actively Recruiting
Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
Led by Brian W. Noehren · Updated on 2025-12-02
60
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. 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. 2. 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. 3. 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.
CONDITIONS
Official Title
Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-50 years old
- Acute ankle injury requiring surgical fixation
- Stable address and phone number for follow-up visits
- English speaking
- Body mass index (BMI) less than or equal to 35 kg/m2
You will not qualify if you...
- Chronic pain lasting more than 3 months and bothersome at least half the days over the past 6 months before the fracture
- Moderate or severe traumatic brain injury
- Initial treatment requiring amputation
- Spinal cord injury
- Unable to speak or read English
- History of schizophrenia, dementia, neurologic disorder with peripheral dysfunction, or other psychotic disorder
- Chronic conditions limiting participation
- Multiple trauma preventing intervention
- Pregnant
- Unable to attend in-person follow-up visits or therapy sessions
- Currently in physical therapy at intervention start
- Use of assistive device for community walking
- Prior lower extremity fracture within past 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
R
Research Associate Senior
CONTACT
P
Principal Investigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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