Recruiting

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

Sponsor:

Brian W. Noehren

Code:

NCT07173088

Conditions

Ankle Fractures

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Ankle Muscle Power (AMP) program

Standard of Care

Study Details

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.

Conditions

Ankle Fractures

Study ID

NCT07173088

Start date

Nov 13, 2025

Status verified date

Nov, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ankle Muscle Power (AMP) program

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

Standard rehabilitation program

Primary outcome measure

Percentage of Participants Adhering to the Intervention [ Time Frame: From baseline assessment to completion of the 10 week intervention. ]
Percentage of Treatment That is Able to be Delivered (Fidelity) [ Time Frame: From baseline assessment to completion of the 10 week intervention. ]
Percentage of Participants Completing the Intervention (Retention) [ Time Frame: From baseline assessment to completion of the 10 week intervention. ]
Percentage of Participants Who Find the Program Acceptable/Satisfactory [ Time Frame: From baseline assessment to completion of the 10 week intervention. ]
Change in Isometric Ankle Plantar Flexor Muscle Power [ Time Frame: Baseline assessment and post intervention visit (10-12 weeks following baseline) ]
Change in Ankle Rate of Torque Development (Ankle RTD) [ Time Frame: Baseline assessment and post intervention visit (10-12 weeks following baseline) ]
Change in Ankle Joint Power During Gait [ Time Frame: Baseline and post intervention (10-12 weeks following baseline) ]
Change in Ankle Joint Power During Stairs (step up and down) [ Time Frame: Baseline and post intervention (10-12 weeks following baseline) ]

Central Contacts and Locations

Central contacts

Research Associate Senior

859-323-5438 delong2@uky.edu

Principal Investigator

859-323-1100 b.noehren@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Research Associate Senior

859-323-5438 delong2@uky.edu

More Information

Sponsor

Brian W. Noehren

Last update posted

Dec 2, 2025

Last verified

Nov, 2025

Keywords

Physical Therapy
Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brian W. Noehren on 2025-12-02.