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Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
NCT07173088 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BEHAVIORAL Standard of Care
- OTHER Ankle Muscle Power (AMP) program
Study Locations (1)
Kentucky
- University of Kentucky — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-11-13 |
| Est. Completion | 2028-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07173088
The ClinicalTrials.gov registry entry for NCT07173088 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brian W. Noehren, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ankle Fractures appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07173088 reports 1 study location spanning 1 distinct geographic area — top geographies include Kentucky. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07173088 about?
NCT07173088 is a clinical study titled "Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture". 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 performan...
What is the current status of trial NCT07173088?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-11-13. Estimated completion is 2028-03.
What conditions does trial NCT07173088 study?
This clinical trial studies the following conditions: Ankle Fractures. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07173088?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Ankle Muscle Power (AMP) program (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07173088?
This trial is sponsored by Brian W. Noehren, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07173088 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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