University of Kentucky
Lexington, Kentucky, 40536, United States
Location status: Recruiting
NCT Number: NCT07173088
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Lexington, Kentucky, 40536, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Physical Therapy
Standard rehabilitation program
Time frame: From baseline assessment to completion of the 10 week 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.
Time frame: From baseline assessment to completion of the 10 week intervention.
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.
Time frame: From baseline assessment to completion of the 10 week intervention.
This will be calculated as the number of participants completing each intervention divided by the number of participants who start each intervention.
Time frame: From baseline assessment to completion of the 10 week intervention.
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.
Time frame: Baseline assessment and post intervention visit (10-12 weeks following baseline)
Will be assessed isotonically on a dynamometer as the change in peak power from baseline to post-intervention follow-up
Time frame: Baseline assessment and post intervention visit (10-12 weeks following baseline)
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.
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture during walking
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Ankle joint power measured with 3D motion capture while climbing stairs
Time frame: Baseline and post intervention (10-12 weeks following baseline)
Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded.
Time frame: Baseline and following completion of the intervention (10-12 weeks post baseline visit)
Participants will walk at their fastest comfortable speed with the time to complete 5 meters recored.
Time frame: Baseline visit and post intervention visit (10-12 weeks post baseline)
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.
Time frame: Baseline and post intervention (10-12 weeks following baseline)
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.
Time frame: Baseline assessment and post intervention visit (10-12 weeks later)
The PROMIS Physical Function computer adaptive test will be administered to each subject. Scale 0-100, where higher numbers indicate better physical functioning. A score of 50 is consistent with the mean score of the U.S. general population.
Time frame: Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention.
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.
Time frame: Baseline, following the intervention (10-12 weeks post intervention), and at a 3 month follow up after completing the intervention.
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.
Time frame: Baseline and post intervention (10-12 weeks following the baseline visit)
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.
Time frame: Baseline, following the intervention (10-12 weeks post intervention) and at a 3 month follow up after completing the intervention.
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.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
A summary score (ranging from 0 to 100) is calculated, with lower scores indicating better outcomes. 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.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
Participants will walk at their fastest comfortable speed with the time to complete 5 meters recorded.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
Participants will walk at a pace that feels normal for the participant with the time to complete 5 meters recorded.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
The stair test is a measurement of functional strength, balance, and agility achieved by ascending and descending a specific number of steps. 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.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
Will be assessed isotonically on a dynamometer as the peak power.
Time frame: After completing isometric phase (16 ± 2 weeks post-op) and concentric phase (20 ± 2 weeks post-op)
Will be assessed isometrically on a dynamometer as the slope of the generated force curve. It is the peak rate of force development measured in Newton meters per second.
Time frame: Baseline assessment and post intervention visit (10-12 weeks following baseline)
The AOFAS Ankle-Hindfoot Scale is a short survey and exam that looks at ankle and foot problems. It measures three main things: pain, how well a person can move and do daily activities, and how well the ankle and foot are lined up. The score goes from 0 to 100, with higher scores meaning less pain and better function. It helps doctors and researchers track recovery and compare treatments.
Contact information is provided by the study sponsor or research team.
Principal Investigator
CONTACT
Research Associate Senior
CONTACT
Brian W. Noehren
Other
Acronym: AMP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07620015
Ankle Fractures, Ankle Injuries
Kyrenia, Cyprus
View Trial DetailsNCT05280639
Ankle Fractures, Ankle Injuries
Charlottesville, Virginia, United States
View Trial DetailsNCT07473947
Ankle Fractures, Ankle Injuries
Turku, Finland
View Trial DetailsNCT07481266
Ankle Fractures, Ankle Injuries
Ankara, Turkey (Türkiye)
View Trial Details