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

Not Applicable

Not yet recruiting

• Conditions: Ankle Fractures

• Registration Number: NCT07173088
• Lead Sponsor: Brian W. Noehren

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Study Start: 2025-10-01
• Primary Completion: 2028-03
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Adhering to the Intervention	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)	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/Satisfactory	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	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 Joint Power During Gait	Baseline and post intervention (10-12 weeks following baseline)	Ankle joint power measured with 3D motion capture during walking
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 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

Secondary Outcome Measures

Name	Time	Method
Change in Usual Gait Speed	Baseline and post intervention (10-12 weeks following baseline)	Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded.
Change in Fastest Gait Speed	Baseline and following completion of the intervention (10-12 weeks post baseline visit)	Participants will walk at their fastest comfortable speed with the time to complete 5 meters recored.
Change in 11 Stair Climb Test Score	Baseline visit and post intervention visit (10-12 weeks post baseline)	The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps (11). Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance.
Change in Ankle fracture outcome rehabilitation measure (A-FORM)	Baseline and post intervention (10-12 weeks following baseline)	The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is a patient-reported outcome measure designed to assess recovery after an ankle fracture. It focuses on physical, social, and psychological aspects of recovery. A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes.
Change in PROMIS Physical Function Computer Adaptive Test	Baseline assessment and post intervention visit (10-12 weeks later)	The PROMIS Physical Function computer adaptive test will be administered to each subject. Scale 0-100, where higher numbers indicate better physical functioning. A score of 50 is consistent with the mean score of the U.S. general population.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States