Actively Recruiting
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Led by Texas Tech University Health Sciences Center · Updated on 2026-03-17
105
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
Texas Tech University Health Sciences Center
Lead Sponsor
T
The Center for Orthopedic Surgery
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of blood flow restriction (BFR) therapy to help patients recover after ankle ligament reconstruction surgery. This randomized clinical trial compares BFR therapy with the current standard physical therapy care to see if BFR improves muscle atrophy, strength recovery, ankle function, pain management, and cardiovascular effects. The study aims to provide clearer evidence on whether adding BFR to rehabilitation can benefit patients' recovery after surgery. Participants who have undergone ankle ligament reconstruction will be randomly assigned to either a standard physical therapy group without BFR or a group receiving physical therapy combined with BFR. Both groups will start therapy at least 28 days after surgery and continue for a minimum of six weeks. The BFR therapy involves applying a special device to the affected limb during therapy sessions to restrict blood flow and support muscle strengthening exercises. Both groups will perform similar exercises, including hip and knee strengthening and ankle movements, with manual therapy as needed. Participants will be assessed at several time points, starting at the beginning of physical therapy, then between 63 and 70 days post-surgery, and optionally at the end of physical therapy if it extends beyond six weeks. Evaluations will measure muscle size, muscle fatigability using manual testing, ankle function with the Foot and Ankle Disability Index, pain levels with a visual analog scale, and cardiovascular measures like resting heart rate and blood pressure. Study physical therapists collecting these data will be unaware of each participant's group to ensure unbiased results.
CONDITIONS
Brief Title
Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-65 years
- Have had ankle ligament reconstruction surgery (medial or lateral, with or without ankle scope)
- Able to pay for physical therapy or have insurance coverage for at least 6 weeks of therapy
You will not qualify if you...
- Major cardiac or connective tissue disorders such as Ehlers-Danlos or Marfan syndrome
- Autoimmune disorders
- History of stroke or deep vein thrombosis (DVT)
- Bleeding or coagulation disorders
- Congenital or developmental musculoskeletal disorders such as cerebral palsy or Parkinson's disease
- Currently pregnant or planning pregnancy within the next 4 months
- Cancer (malignancy)
- Professional athletes
- Workers compensation insurance status that does not cover minimum 4 weeks of physical therapy
- Current or recent participation in another interventional clinical trial within 30 days before consent
- Deemed unsuitable for the study by the investigators
- Cognitive impairment preventing consent or participation (e.g., dementia, severe developmental delay, language or communication limitations, brain injury)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 weeks
Participants receive physical therapy starting at least 28 days post-operative, with the treatment group receiving blood flow restriction (BFR) therapy during weekly sessions and the standard of care group receiving usual physical therapy without BFR. Exercises focus on hip and knee strength, with ankle strengthening performed in a seated position. Manual therapy may be provided as needed.
Weekly visits for up to 6 weeks
Duration - Up to 10 weeks post-op
Participants undergo follow-up assessments to measure muscle recovery, fatigability, ankle functionality, pain levels, and cardiovascular impact. These assessments are conducted by study physical therapists who are blinded to treatment assignment.
3 visits: baseline at start of physical therapy (28 days post-op + 7 days), Visit 2 at 63-70 days post-op, and an optional Visit 3 at the end of physical therapy
Trial Site Locations
Total: 5 locations
1
Physical Therapy Today (PTT)
Lubbock, Texas, United States, 79407
Active, Not Recruiting
2
University Medical Center
Lubbock, Texas, United States, 79415
Active, Not Recruiting
3
Northstar Surgery Center
Lubbock, Texas, United States, 79416
Active, Not Recruiting
4
The Center for Orthopedic Surgery
Lubbock, Texas, United States, 79416
Actively Recruiting
5
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
Actively Recruiting
Research Team
J
Jenny Hudnall, MS BME
E
Evan Hernandez, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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