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

Part of paid clinical trials in Lubbock, Texas.

Sponsor
Texas Tech University Health Sciences Center
Study ID
NCT07451210
Status
Recruiting
Apply to this trial

Conditions

  • Ankle Reconstruction
  • Blood Flow Restriction Therapy
  • Physical Therapy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • blood flow restriction — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Mar 1, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of Care (SOC) group
    standard course of physical therapy; no BFR
  • Experimental: Blood flow restriction (BFR) group
    BFR device added during physical therapy

Primary Outcome Measure

Muscle atrophy measurement - gastrocnemius [ Time Frame: baseline/Visit 1 (28 days + 7 days post-op), Visit 2 (63-70 days post op), Visit 3 (optional - upon completion of PT) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Northstar Surgery CenterLubbockTexas79416-
Physical Therapy Today (PTT)LubbockTexas79407-
Texas Tech University Health Sciences CenterLubbockTexas79430
Jerry Grimes MD, MD
[email protected]
+18067432465
Jenny Hudnall, MS BME
[email protected]
Jerry Grimes, MD (PRINCIPAL_INVESTIGATOR)
Jean-Michel Brismée, PT; ScD (SUB_INVESTIGATOR)
The Center for Orthopedic SurgeryLubbockTexas79416
Kenneth Stephenson, MD
[email protected]
(806) 797-4985
Kenneth Stephenson, MD (SUB_INVESTIGATOR)
University Medical CenterLubbockTexas79415-

Find similar trials in Lubbock, TX

By research site
Northstar Surgery Center· Lubbock, TXPhysical Therapy Today (PTT)· Lubbock, TXTexas Tech University Health Sciences Center· Lubbock, TXThe Center for Orthopedic Surgery· Lubbock, TXUniversity Medical Center· Lubbock, TX

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