The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.
Methodist Hospital
Indianapolis, Indiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Knee Strength measured using a stabilized hand held dynamometer
Knee strength will be measured using a stabilized hand held dynamometer in both the injured and uninjured legs.
Time frame: up to 6 months
Muscle Volume assessed using mid-thigh girth circumference measurement
Muscle volume will be assessed using mid-thigh girth circumference measurements.
Time frame: up to 6 months
Strength
Strength will be measured using the sit to stand test.
Time frame: up to 6 months
Speed
Speed will be evaluated using the self selected walking speed.
Time frame: up to 6 months
Speed
Speed will be evaluated using the 40 yard shuttle run.
Time frame: up to 6 months
Posture Stability
Postural stability will be evaluated using the single leg stance.
Time frame: Change in Functional Performance Measures at 3 months and 6 months
Agility
Agility will be measured using the 4 step square test.
Time frame: up to 6 months
Agility
Agility will be measured using the Illinois Agility Test.
Time frame: up to 6 months
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Carolinas Medical Center
Charlotte, North Carolina, United States
MetroHealth
Cleveland, Ohio, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
San Antonio Military Medical Center
San Antonio, Texas, United States
Physical Function
Physical Function will be evaluated by the Patient Reported Outcomes Measurement Information System physical function questionnaire.
Time frame: up to 1 year
Depression evaluated with a depression questionnaire
Depression will be evaluated by the Patient Reported Outcomes Measurement Information System depression questionnaire.
Time frame: up to 1 year
Anxiety evaluated with an anxiety questionnaire
Anxiety will be evaluated by the Patient Reported Outcomes Measurement Information System anxiety questionnaire.
Time frame: up to 1 year
Sleep Disturbance evaluated with a sleep disturbance questionnaire
Sleep Disturbance will be evaluated by the Patient Reported Outcomes Measurement Information System sleep disturbance questionnaire.
Time frame: up to 1 year
Psychological outcome-Post Traumatic Stress (PTSD) measured using the standard PTSD Checklist (PCL)
PTSD will be measured using the standard PTSD Checklist (PCL).
Time frame: up to 1 year
Return to Work and Work Productivity measured using the Work Productivity and Activity Impairment (WPAI) questionnaire
Work productivity will be measured using the Work Productivity and Activity Impairment (WPAI) questionnaire.
Time frame: up to 1 year
Pain evaluated with a Pain Inference scale
Pain will be evaluated by the Patient Reported Outcomes Measurement Information System Pain Inference scale.
Time frame: up to 1 year
Satisfaction with Care and Recovery assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS)
This will be assessed using the MedRisk Instrument for Measuring Patient Satisfaction with Physical Therapy Care (MRPS).
Time frame: 3 months
Fracture Healing
Fracture healing will be determined by clinical examinations.
Time frame: up to 1 year
Fracture Healing
Fracture healing will be determined by radiographic examinations.
Time frame: up to 1 year
Complications
The presence of all limb related complications will be recorded prospectively at each follow up visit, and categorized according to type, date diagnosed, severity, treatment and relation to the study injury.
Time frame: up to 1 year