Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Brian W. Noehren
Study ID
NCT07173088
Status
Recruiting
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Conditions

  • Ankle Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • Standard of Care — BEHAVIORAL
    Standard rehabilitation program

Study Details

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.

Key Dates

Start date
Nov 13, 2025
Status verified
Nov 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ankle Muscle Power (AMP) program + standard of care
    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.
  • Active Comparator: Standard of care only
    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.

Primary Outcome Measure

Percentage of Participants Adhering to the Intervention [ Time Frame: From baseline assessment to completion of the 10 week intervention. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40536
Research Associate Senior
[email protected]
859-323-5438

Find similar trials in Lexington, KY

By research site
University of Kentucky· Lexington, KY

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