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

NCT07173088 | Recruiting

• 2 other identifiers: 103812HT9425-25-1-0625
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Assess feasibility and define the initial effects of the AMP program on ankle plantar flexor rate of torque development and ankle power.
2. 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. 3.Assess the preliminary efficacy of the AMP program on patient reported outcomes and quality of life.

Conditions

Ankle Fractures

Keywords

Physical Therapy; Rehabilitation

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Adhering to the 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.

  From baseline assessment to completion of the 10 week intervention.

• Percentage of Treatment That is Able to be Delivered (Fidelity)

  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.

  From baseline assessment to completion of the 10 week intervention.

• Percentage of Participants Completing the Intervention (Retention)

  This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.

  From baseline assessment to completion of the 10 week intervention.

• Percentage of Participants Who Find the Program Acceptable/Satisfactory

  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.

  From baseline assessment to completion of the 10 week intervention.

• Change in Isometric Ankle Plantar Flexor Muscle Power

  Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up

  Baseline assessment and post intervention visit (10-12 weeks following baseline)

• Change in Ankle Rate of Torque Development (Ankle RTD)

  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.

  Baseline assessment and post intervention visit (10-12 weeks following baseline)

• Change in Ankle Joint Power During Gait

  Ankle joint power measured with 3D motion capture during walking

  Baseline and post intervention (10-12 weeks following baseline)

• Change in Ankle Joint Power During Stairs (step up and down)

  Ankle joint power measured with 3D motion capture while climbing stairs

  Baseline and post intervention (10-12 weeks following baseline)

Secondary Outcomes (5)

• Change in Usual Gait Speed

  Baseline and post intervention (10-12 weeks following baseline)

• Change in Fastest Gait Speed

  Baseline and following completion of the intervention (10-12 weeks post baseline visit)

• Change in 11 Stair Climb Test Score

  Baseline visit and post intervention visit (10-12 weeks post baseline)

• Change in Ankle fracture outcome rehabilitation measure (A-FORM)

  Baseline and post intervention (10-12 weeks following baseline)

• Change in PROMIS Physical Function Computer Adaptive Test

  Baseline assessment and post intervention visit (10-12 weeks later)

Other Outcomes (11)

• Change in Brief Pain Inventory (BPI)

  Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention.

• Change in Tampa Scale of Kinesiophobia (TSK)

  Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention.

• Ankle Plantar Flexor muscle cross sectional area

  Baseline and post intervention (10-12 weeks following the baseline visit)

Study Arms (2)

Ankle Muscle Power (AMP) program + standard of care

EXPERIMENTAL

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.

Other: Ankle Muscle Power (AMP) program; Behavioral: Standard of Care

Standard of care only

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care

Interventions

Ankle Muscle Power (AMP) program OTHER

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.

Also known as: Physical Therapy

Ankle Muscle Power (AMP) program + standard of care

Standard of Care BEHAVIORAL

Standard rehabilitation program

Ankle Muscle Power (AMP) program + standard of care; Standard of care only

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian W. Noehren: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

MeSH Terms

Conditions

Ankle Fractures

Interventions

Adenosine Monophosphate; Physical Therapy Modalities; Standard of Care

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Therapeutics; Rehabilitation; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Principal Investigator

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Associate Senior

CONTACT

859-323-5438; delong2@uky.edu

Principal Investigator

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 15, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available at the time of manuscript acceptance and publishing. A published manuscript is planned for mid 2029.
• Access Criteria: Any external researcher will be able to access de-identified, non-PHI, individual participant data as part of the journal's supplementary information.

Locations

US (1)