NCT07173088: AMP

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

Recruiting now NA Last updated 24 November 2025

What this trial tests

NA trial testing Ankle Muscle Power (AMP) program in Ankle Fractures in 60 participants. Currently enrolling.

Timeline

13 November 2025

Primary endpoint
1 March 2028

1 March 2028

Quick facts

Lead sponsor	Brian W. Noehren
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	60
Start date	13 November 2025
Primary completion	1 March 2028
Estimated completion	1 March 2028
Sites	1 location across United States

Drugs / interventions tested

• Ankle Muscle Power (AMP) program
• Standard of Care

Conditions studied

• Ankle Fractures — all drugs for Ankle Fractures →

Sponsor

Brian W. Noehren

Who can join

Adults 18 to 50, any sex, with Ankle Fractures. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants Adhering to the Intervention
  Time frame: From 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)
  Time frame: 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)
  Time frame: 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/Satisfactory
  Time frame: From 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 Power
  Time frame: Baseline 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)
  Time frame: 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.