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

Brian W. Noehren

Status: Enrolling

Conditions: Ankle Fractures

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07173088

HT9425-25-1-0625 (Other Grant/Funding Number)

103812

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Ankle Muscle Power (AMP) program + standard of care

Experimental group

Description:

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.

Treatment:

Other: Ankle Muscle Power (AMP) program

Behavioral: Standard of Care

Standard of care only

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of Care