NCT07451210 · Texas Tech University Health Sciences Center
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
(BFRankle recon)
What this study is about
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 the usual treatment (SoC) and BFR groups at the end of the study intervention.
View original scientific description
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).
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.
Primary outcome measures
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)
Measurement location: maximal circumference of the gastrocnemius muscle Unit: cm Range: varies by participant
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)
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)
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)
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)
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)
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)
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)
Measurement description: Pain will be assessed using a visual analog scale (VAS), rated from 0-10, and recorded during the study visits to help evaluate the effectiveness of BFR therapy in reducing pain during rehabilitation. They will also be verbally asked during each therapy session to ensure subject comfort. Score range: 0 - 10 (higher score indicates higher levels of pain)
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)
Measurement description: Resting heart rate will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: beats per minute (bpm)
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)
Measurement description: Resting blood pressure will be measured u to determine if BFR therapy provides any incidental cardiovascular benefits. Measurement tool: automatic cuff (Omron Bronze, OMRON HEALTHCARE CO Kyoto, Japan) Range: varies by participant Units: systolic/diastolic in mmHg
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Be deemed unsuitable for inclusion in the study at the discretion of the Investigators
- Cognitively not able to consent or participate in research (dementia; severe developmental delay; language/communication limitations; brain injury; etc.)
Where
- Lubbock, Texas
Collaborators
The Center for Orthopedic Surgery, UMC Health System, H2 Health (Physical Therapy Today), Northstar Surgery Center
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations