Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture (NCT07173088)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Kentucky — Lexington, Kentucky
Age range: 18 Years to 50 Years
🧪 Interventions in This Study
- Ankle Muscle Power (AMP) program (OTHER)
- Standard of Care (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- University of Kentucky — Lexington, Kentucky
📞 Contact the Study Coordinator
Phone: (859) 323-5438
Email: delong2@uky.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Ankle Fractures
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- Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery — Boston, Massachusetts
- Neuromuscular Electrical Stimulation in Foot and Ankle Surgery — New York, New York
- Simplified Post Op Rehabilitation for Ankle and Pilon Fractures — Charlottesville, Virginia
- Randomized Controlled Trial for Ankle Fracture Pain Control — Burlington, Massachusetts
Explore by condition: All Ankle Fractures clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.