Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction

Texas Tech University Health Sciences Center5 sites in 1 country105 target enrollmentStarted: March 1, 2026Last updated: March 17, 2026

Interventionsblood flow restriction

Overview

Phase: Not Applicable
Status: Recruiting
Sponsor: Texas Tech University Health Sciences Center
Enrollment: 105
Locations: 5
Primary Endpoint: Muscle atrophy measurement - gastrocnemius

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

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).

Detailed Description

Study Aims:

To evaluate the efficacy of Blood Flow Restriction (BFR) therapy compared to the current standard of care (SOC) in improving muscle atrophy, strength recovery, ankle functionality, and pain management in patients undergoing rehabilitation after ankle ligament reconstruction.

Objectives:

Evaluate Muscle Atrophy: To compare the extent of muscle recovery in the quadriceps and gastrocnemius muscles between patients receiving BFR therapy and those receiving the current standard of care. This will be done by comparing muscle circumference

Assess Fatigability Recovery: To determine whether BFR therapy accelerates the recovery of dynamic lower extremity fatigability more effectively than the current standard of care as measured by manual muscle testing (MMT)

Measure Functional Outcomes: To use the Foot and Ankle Disability Index (FADI) to evaluate improvements in ankle functionality and activities of daily living between the two treatment groups.

Monitor Pain Levels: To compare perceived pain levels during treatment and daily activities in patients undergoing BFR therapy versus those receiving standard care using a visual analog scale (VAS)

Analyze Cardiovascular Impact: To investigate changes in resting heart rate and blood pressure to identify any cardiovascular benefits associated with BFR therapy compared to the current standard of care

Study overview:

This study is designed as a randomized clinical trial to evaluate the efficacy of Blood Flow Restriction (BFR) therapy in postoperative rehabilitation following ankle ligament reconstruction.

Patients who have undergone ankle ligament reconstruction surgery performed by participating orthopedic surgeons will be randomized to either the treatment group (BFR therapy) or standard of care (SOC) group. Patients will then receive physical therapy (PT) managed by treatment physical therapists (t-PT). These therapists will perform BFR during the weekly PT sessions and provide the same at home exercises for participants in both groups. These physical therapists will not be part of the study team and will not collect study related data.

Patients in the treatment group will begin BFR therapy at least 28 days post-op (+7 days). The therapy will be performed on the affected limb, focusing on hip and knee strength, with ankle strengthening in plantarflexion and dorsiflexion in a seated position. Additional exercises include multi-joint hip and knee strengthening, such as straight leg raises, side-lying external rotation hip exercises (clam shells), short arc quads, long arc quads, hamstring curls, and hip bridges. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the physical therapist.

The SOC group will receive traditional physical therapy methods without BFR at least 28 days post-op (+ 7 days). The protocol will include similar exercises to those in the BFR group but without occlusion. Manual therapy including soft tissue mobilization and joint mobilization for ROM restoration will be provided as needed at the discretion of the t-PT.

Follow-up assessments and outcomes of interest will be collected by the study physical therapists (s-PT). s-PTs collecting study visit data will be blinded to the patient's treatment group. These measures include: muscle circumference (quadriceps and gastrocnemius), manual muscle testing (MMT) for fatigability recovery, Foot and Ankle Disability Index (FADI) for functional outcomes, pain levels using a visual analog scale (VAS), and cardiovascular measures (resting heart rate and blood pressure).

Assessments will be conducted at multiple time points for both the treatment and SOC groups:

Baseline: At initiation of physical therapy (28 days post-op + 7 days)) Visit 2: 63-70 days post-op Visit 3 (optional): At the end of the study (for patients continuing beyond the standard 6-weeks of physical therapy)

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Outcomes Assessor)

Masking Description

Following enrollment, subjects will be randomly assigned to either the intervention group (BFR therapy) or the control group (SOC). Patients will be randomized using sequentially numbered opaque sealed envelopes (SNOSE) with their treatment group and study ID number pre-assigned. These envelopes will contain the information regarding their randomization and will not be opened until after the patient is consented for the study.

The subject's treatment group will be communicated to their t-PT, after they have conducted the first visits' measurements. The t-PT will not perform any data collection for the subjects they treat and will and will perform physical therapy for those patients.

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
•Pregnancy (current or planning to become pregnant in the next 4 months)
•Malignancy (cancer).
•Professional athletes.
•Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
•Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or

Arms & Interventions

Standard of Care (SOC) group

No Intervention

standard course of physical therapy; no BFR

Blood flow restriction (BFR) group

Experimental

BFR device added during physical therapy

Intervention: blood flow restriction (Device)