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

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).

Conditions

• Ankle Reconstruction
• Blood Flow Restriction Therapy
• Physical Therapy

Interventions

DEVICE

blood flow restriction

The 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.

Sponsors & Collaborators

• The Center for Orthopedic Surgery

  collaborator UNKNOWN

• UMC Health System

  collaborator UNKNOWN

• H2 Health (Physical Therapy Today)

  collaborator UNKNOWN

• Northstar Surgery Center

  collaborator UNKNOWN

• Texas Tech University Health Sciences Center

  lead OTHER

Principal Investigators

• Jerry Grimes, MD · Texas Tech University Health Sciences Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-01

Primary Completion

2027-06-30

Completion

2027-12-31

Countries

• United States

Study Locations