Ankle Muscle Power Program for Ankle Fracture

(AMP Trial)

Overseen By Principal Investigator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Brian W. Noehren

Disqualifiers: Chronic pain, Brain injury, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding specific exercises to boost ankle muscle power can improve recovery after an ankle fracture. It compares a regular physical therapy program with one that includes these additional exercises, known as the Ankle Muscle Power program. The researchers aim to determine if the new program enhances mobility and improves participants' perceptions of their recovery. Individuals who have recently undergone ankle surgery and do not suffer from chronic pain or other major health issues may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative rehabilitation strategies and potentially enhance participants' recovery experiences.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Ankle Muscle Power program is safe for ankle fracture rehabilitation?

Research has shown that physical therapy programs, such as the Ankle Muscle Power (AMP) program, are generally safe and manageable. Studies on similar programs have found improvements in muscle function and movement without serious side effects. Participants perform exercises to increase muscle strength and power, with adjustments made as they progress.

While specific safety data for the AMP program is not available, exercises for ankle recovery in physical therapy have a strong safety record. These exercises focus on gradual improvement and are supervised by trained therapists, which helps prevent injuries or other issues. For any concerns, discussing them with the research team or a physical therapist is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ankle Muscle Power (AMP) program because it adds a new dimension to traditional ankle rehabilitation. Unlike standard treatments that focus on range of motion and foundational strength, the AMP program emphasizes developing muscle power, which could enhance recovery and performance. By integrating specific power-building exercises into the rehabilitation process, the AMP program aims to improve outcomes for ankle fracture patients, potentially leading to a faster and more robust return to normal activities.

What evidence suggests that the Ankle Muscle Power program is effective for ankle fracture rehabilitation?

Research shows that specific exercises to strengthen ankle muscles can enhance recovery after an ankle fracture. Studies have found that early rehabilitation, involving ankle movement and balance improvement exercises, leads to better outcomes. Individuals with similar injuries experienced improved ankle movement and stronger muscles. Evidence suggests that exercise programs focusing on muscle strength can enhance physical performance and quality of life. In this trial, participants will receive either the Ankle Muscle Power (AMP) program alongside standard care or standard care alone. Overall, these findings support the potential benefits of the AMP program in aiding recovery from an ankle fracture. ^{4 6 7 8 9}

Who Is on the Research Team?

Principal Investigator

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals recovering from an ankle fracture. Participants should be willing to undergo standardized physical therapy and adhere to the rehabilitation program, which includes exercises aimed at improving muscle power.

Inclusion Criteria

Must have stable address and phone number to schedule follow up contact visits

English speaking

BMI ≤ 35 kg/m2

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Ankle Muscle Power (AMP) program or standard of care rehabilitation for up to 12 weeks, with an average of 3 visits per week.

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with exploratory outcomes assessed 3 months after completing the intervention.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Muscle Power (AMP) program

Trial Overview The study compares standard care with a specialized Ankle Muscle Power (AMP) program in terms of adherence, muscle function, physical performance, and patient satisfaction. It will measure improvements in torque development and power during walking and stair climbing.

How Is the Trial Designed?

Group I: Ankle Muscle Power (AMP) program + standard of care Experimental Treatment 2 Interventions

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.

Group II: Standard of care only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Brian W. Noehren

Lead Sponsor

Trials

2

Recruited

120+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07173088

Efficacy and Clinical Feasibility of the Ankle Muscle Power ... The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880611/

Efficacy of adding mobilization and balance exercises to a ... Active controlled motion in early rehabilitation improves outcome after ankle fractures: a randomized controlled trial. Clin Rehabil. (2017) ...

3. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005595.pub4/abstract

Rehabilitation for ankle fractures in adults - Lewis, SR - 2024 We collected data for five outcomes: activity limitation (ankle ... recovery period to increase ankle movement or muscle strength, or both.

4. nature.com nature.com/articles/s41598-025-95896-w

Effectiveness of exercise therapy on chronic ankle instability Long-term, multifaceted exercise therapy demonstrates superior rehabilitation efficacy for patients with CAI.

5. htsyndication.com htsyndication.com/health-daily-digest/article/clinical-trial%3A-efficacy-and-clinical-feasibility-of-the-ankle-muscle-power--amp--program-for-return-to-duty-after-an-ankle-fracture/93272457

Efficacy and Clinical Feasibility of the Ankle Muscle Power ... Researchers will evaluate to see if the addition of ankle muscle power exercises (AMP) improve program adherence, muscle function, physical ...

6. trialx.com trialx.com/clinical-trials/listings/309343/efficacy-and-clinical-feasibility-of-the-ankle-muscle-power-amp-program-for-return-to-duty-after-an-ankle-fracture/

Efficacy and Clinical Feasibility of the Ankle Muscle Power ... The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle fracture.

7. uky.trialstoday.org uky.trialstoday.org/trial/NCT07173088

Efficacy and Clinical Feasibility of the Ankle Muscle Power ... The goal of this clinical trial is to compare two different standardized physical therapy rehabilitation programs on outcomes after an ankle ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11316413/

Comparative Analysis of Rehabilitation Strategies Following ... This systematic review will cover the wide range of rehabilitation interventions after ankle fracture surgery to establish the best approach that should be ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03447652

A Study Investigating The Effects Of An Ankle ... A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.