The goal of this single blinded clinical trial is to investigate blood flow restriction (BFR) for rehabilitation of patients after ankle ligament reconstruction surgery. Outcome measures will be compared between the standard of care (SoC) and BFR groups at the end of the study intervention.
Following standard surgical procedures, both groups will undergo physical therapy by a certified physical therapist for a minimum of 6 weeks. The SOC group will receive standard physical therapy without use of BFR. The BFR group will receive physical therapy with BFR. Outcome measures of interest will be taken at the start of physical therapy (time 0) and at the end of physical therapy (minimum of 6 weeks of PT) for both groups.
Outcome measures of interest include:
* muscle atrophy; * ankle function; * fatigability/manual muscle testing; * pain scores; * cardiovascular effects (heart rate, blood pressure).
Age 18-65 years.
Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.
Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
Autoimmune disorders.
History of stroke or deep vein thrombosis (DVT).
Bleeding or coagulation disorders.
Parallel
blood flow restriction
DeviceThe intervention group will receive the standard of care PT performed with BFR on affected limb. The intervention group will be treated with a BFR Smarttools SmartCuffs versions 3.0 or higher. During the baseline visit, the device will be placed over the affected limb's greater trochanter and inflated to 60% of their limb occlusion pressure. This will be titrated up to 80% over the first week to ensure subject comfort. During the remaining physical therapy sessions, patients will perform exercises prescribed by a licensed t-PT to perform under occlusion with a load of 30% of the subjects estimated 1-rep max.
Muscle atrophy measurement - gastrocnemius
Measurement location: maximal circumference of the gastrocnemius muscle Unit: cm Range: varies by participant
Muscle atrophy measurement - quadriceps
Measurement location: 10 cm and 20 cm above the superior aspect of the patella Unit: cm Range: varies by participant
Fatigability recovery using manual muscle testing (MMT)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Foot and Ankle Disability Index (FADI)
Measurement description: Manual muscle testing (MMT) will be used to evaluate plantar flexion fatigability with the ankle in a neutral position, unweighted. This will help determine the effectiveness of BFR therapy in restoring muscle fatigability compared to the standard of care. Score range: 5 - 10+ (higher score indicates better fatigability recovery)
Click on the lead sponsor to view all of their trials.
Texas Tech University Health Sciences Center
Lead sponsor
The Center for Orthopedic Surgery
Collaborator
UMC Health System
Collaborator
H2 Health (Physical Therapy Today)
Collaborator
Northstar Surgery Center
Collaborator
