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.
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
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
Parallel
Ankle Muscle Power (AMP) program
Other interventionThe 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
BehavioralStandard rehabilitation program
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.
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.
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.
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.
Change in Usual Gait Speed
Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded.
Change in Fastest Gait Speed
Participants will walk at their fastest comfortable speed with the time to complete 5 meters recored.
Change in 11 Stair Climb Test Score
The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps (11). Scoring involves recording the total time taken to ascend and descend the steps to the nearest 100th of a second. Lower values indicate better performance.
Change in Ankle fracture outcome rehabilitation measure (A-FORM)
The Ankle Fracture Outcome of Rehabilitation Measure (A-FORM) is a patient-reported outcome measure designed to assess recovery after an ankle fracture. It focuses on physical, social, and psychological aspects of recovery. A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes.
Change in Brief Pain Inventory (BPI)
This patient reported outcome measures assesses pain severity and interference. Scores range from 0-10 for each subscale of pain/severity or interference/impact with higher scores indicating greater pain severity and impact of pain. Scores can be compared to norms to determine if pain is considered significant.
Change in Tampa Scale of Kinesiophobia (TSK)
A patient reported outcome measures that assesses fear of movement due to pain. The full TSK (17-item) yields a total score between 17 and 68, where higher scores indicate greater kinesiophobia.
Ankle Plantar Flexor muscle cross sectional area
The cross sectional area of the gastrocnemius muscle will be evaluated using ultrasound imaging. The area of the muscle will be measured in cm squared.
Change in the Work Productivity and Activity Impairment Questionnaire (WPAI)
A patient reported outcome measures that assesses impairments in work productivity following an injury. The WPAI questionnaire yields four scores; absenteeism, presenteeism, overall work impairment, and activity impairment which are expressed as percentages. Absenteeism is calculated as hours missed divided by total hours available for work. Presenteeism is derived from the 0-10 scale measuring health's impact on productivity while working. Overall work impairment combines both, and activity impairment measures health's effect on non-work tasks. Higher percentage scores indicate greater impairment and reduced productivity.
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Brian W. Noehren
Lead sponsor
University of Kentucky
Sponsor institution
