NCT07451210 Evaluating the Efficacy of Blood Flow Restriction Therapy in a Randomized Clinical Trial for Postoperative Rehabilitation Following Ankle Ligament Reconstruction
| NCT ID | NCT07451210 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas Tech University Health Sciences Center |
| Condition | Ankle Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 105 participants in total. It began in 2026-03-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.)
Contact & Investigator
Jerry Grimes, MD
PRINCIPAL INVESTIGATOR
Texas Tech University Health Sciences Center
Frequently Asked Questions
Who can join the NCT07451210 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ankle Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07451210 currently recruiting?
Yes, NCT07451210 is actively recruiting participants. Contact the research team at jennifer.hudnall@ttuhsc.edu for enrollment information.
Where is the NCT07451210 trial being conducted?
This trial is being conducted at Lubbock, United States, Lubbock, United States, Lubbock, United States, Lubbock, United States and 1 additional location.
Who is sponsoring the NCT07451210 clinical trial?
NCT07451210 is sponsored by Texas Tech University Health Sciences Center. The principal investigator is Jerry Grimes, MD at Texas Tech University Health Sciences Center. The trial plans to enroll 105 participants.