Recruiting

BFR

Sponsor:

Texas Tech University Health Sciences Center

Code:

NCT07451210

Conditions

Ankle Reconstruction

Blood Flow Restriction Therapy

Physical Therapy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

blood flow restriction

Study Details

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).

Conditions

Ankle Reconstruction

Blood Flow Restriction Therapy

Physical Therapy

Study ID

NCT07451210

Start date

Mar 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18-65 years.
2. Post ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope).
3. Capability of paying for physical therapy or having insurance coverage for at least 6 weeks of therapy.

Exclusion Criteria:

1. Major cardiac or connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome).
2. Autoimmune disorders.
3. History of stroke or deep vein thrombosis (DVT).
4. Bleeding or coagulation disorders.
5. Congenital or developmental musculoskeletal disorders (e.g., cerebral palsy, Parkinson's disease).
6. Pregnancy (current or planning to become pregnant in the next 4 months)
7. Malignancy (cancer).
8. Professional athletes.
9. Workers compensation insurance status as worker's compensation often does not cover the necessary duration of physical therapy (minimum of 4 weeks).
10. Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
11. Be deemed unsuitable for inclusion in the study at the discretion of the Investigators
12. Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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) ]
  • Muscle atrophy measurement - quadriceps [ 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) ]
  • Fatigability recovery using manual muscle testing (MMT) [ 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) ]
  • Foot and Ankle Disability Index (FADI) [ 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) ]
  • Pain Management - Visual analog scale [ 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) ]
  • Cardiovascular impact - heart rate [ 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) ]
  • Cardiovascular impact - blood pressure [ 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 and Locations

Central contacts

Jenny Hudnall, MS BME

806-743-2260jennifer.hudnall@ttuhsc.edu

Evan Hernandez, MBA

806-743-4600Evan.J.Hernandez@ttuhsc.edu

Locations

The Center for Orthopedic Surgery

Recruiting

Lubbock, Texas, United States, 79416

Contacts

Kenneth Stephenson, MD

(806) 797-4985ken4feet@aol.com

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Jerry Grimes MD, MD

+18067432465Jerry.Grimes@ttuhsc.edu

Jenny Hudnall, MS BME

jennifer.hudnall@ttuhsc.edu

Principal Investigator:

Jerry Grimes, MD

More Information

Sponsor

Texas Tech University Health Sciences Center

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • ankle reconstruction
  • physical therapy
  • blood flow restriction therapy
  • BFR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Tech University Health Sciences Center on 2026-03-17.