Actively Recruiting
Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
Led by Brian W. Noehren · Updated on 2025-12-02
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two different standardized physical therapy rehabilitation programs for adults aged 18 to 50 who have had an ankle fracture requiring surgical fixation. The study aims to see if adding an ankle muscle power (AMP) exercise program improves muscle function, physical performance, program adherence, and patient-reported outcomes compared to standard rehabilitation alone. This includes assessing ankle muscle power, rate of torque development, joint power during walking and stair climbing, and quality of life after the intervention. Participants will be randomly assigned to either the AMP program alongside standard care or to the standard care program alone. The AMP program involves three stages of muscle power training exercises added to usual rehabilitation, starting about 12 weeks after surgery and lasting up to 12 weeks with an average of three visits per week. The standard care group receives usual physical therapy including range of motion exercises, foundational strength training, and other treatments as directed by their therapist. Participants will be assessed at the start of the study and after completing the 10 to 12 week intervention for outcomes such as adherence to the program, treatment fidelity, retention, muscle power, gait speed, stair climb performance, and patient-reported quality of life measures. Additional exploratory outcomes will be assessed three months after intervention completion to understand longer-term effects. The study includes careful monitoring and evaluation of physical performance and patient satisfaction throughout the rehabilitation process.
CONDITIONS
Brief Title
Efficacy and Clinical Feasibility of the Ankle Muscle Power (AMP) Program for Return to Duty After an Ankle Fracture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64; 35 kg/m2
You will not qualify if you...
- History of chronic pain lasting more than 3 months and bothersome at least half the days over the past 6 months 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 disorders with peripheral dysfunction, or other psychotic disorders
- Any chronic conditions limiting ability to participate in the intervention
- Multiple trauma preventing intervention participation
- Pregnant
- Unable to participate in or complete in-person follow up visits or therapy sessions
- Currently in physical therapy at the start of the intervention
- Use of an assistive device for community walking
- Prior lower extremity fracture within the past 2 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants undergo a rehabilitation program starting approximately 12 weeks after surgery. This includes either the Ankle Muscle Power (AMP) program combined with standard rehabilitation exercises or standard rehabilitation exercises alone to aid recovery after an ankle fracture.
Visits approximately 3 times per week for up to 12 weeks
Trial Site Locations
Total: 1 location
1
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
Research Team
R
Research Associate Senior
P
Principal Investigator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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