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Ankle Muscle Power (AMP) Program for Ankle Fracture Recovery

This study is looking at whether adding a special set of exercises, called the Ankle Muscle Power (AMP) program, can help people recover better after an ankle fracture. You would receive either the AMP program along with standard rehabilitation, or just the standard rehabilitation. Researchers want to see if the AMP program helps you stick with your exercises, improves your muscle strength and physical abilities, and makes you feel better overall. They are also checking how practical and effective the AMP program is. To join, you need to be between 18 and 50 years old, have recently had surgery for an ankle fracture, speak English, and have a BMI (Body Mass Index) of 35 or less. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 60 participants. It compares two different rehabilitation programs for ankle fractures.
What's involved
You would participate in a rehabilitation program over 10 weeks. This includes either standard exercises or standard exercises plus the AMP program.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored from the start of the study until the completion of the 10-week intervention.

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NCT07173088

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

Recruiting
NAAges 18–50InterventionalTreatment
Brian W. Noehren
~60 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:Ankle Muscle Power (AMP) programStandard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Adhering to the Intervention
Measured over From baseline assessment to completion of the 10 week intervention.
+7 more outcomes measured

Conditions

Ankle Fractures

Explore related trials

Ankle Fracture

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Principal Investigator · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Research Associate Senior
[email protected]
859-323-5438
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-50 years old
Acute orthopedic injury to the ankle requiring surgical fixation
Must have stable address and phone number to schedule follow up contact visits
English speaking
BMI ≤ 35 kg/m2

Exclusion

History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started 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 based upon medical record or patient self-report
Any chronic conditions that would limit their ability to participate in an intervention
Multiple trauma that prevents engaging in intervention
Pregnant
Unable to participate in or complete in-person follow up visits or therapy sessions
In Physical Therapy at the start of the intervention.
Use of an assistive device to walk for community ambulation
Prior lower extremity fracture within the past 2 years

What this trial measures

  • Percentage of Participants Adhering to the InterventionFrom baseline assessment to completion of the 10 week 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.

  • Percentage of Treatment That is Able to be Delivered (Fidelity)From baseline assessment to completion of the 10 week intervention.

    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.

  • Percentage of Participants Completing the Intervention (Retention)From baseline assessment to completion of the 10 week intervention.

    This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.

  • Percentage of Participants Who Find the Program Acceptable/SatisfactoryFrom baseline assessment to completion of the 10 week intervention.

    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.

  • Change in Isometric Ankle Plantar Flexor Muscle PowerBaseline assessment and post intervention visit (10-12 weeks following baseline)

    Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up

  • Change in Ankle Rate of Torque Development (Ankle RTD)Baseline assessment and post intervention visit (10-12 weeks following baseline)

    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.

  • Change in Ankle Joint Power During GaitBaseline and post intervention (10-12 weeks following baseline)

    Ankle joint power measured with 3D motion capture during walking

  • Change in Ankle Joint Power During Stairs (step up and down)Baseline and post intervention (10-12 weeks following baseline)

    Ankle joint power measured with 3D motion capture while climbing stairs