Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07451210

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

95 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

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-65 years
  • Have undergone 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
Not Eligible

You will not qualify if you...

  • Major cardiac or connective tissue disorders such as Ehlers-Danlos syndrome or Marfan syndrome
  • Autoimmune disorders
  • History of stroke or deep vein thrombosis (DVT)
  • Bleeding or coagulation disorders
  • Congenital or developmental musculoskeletal disorders like cerebral palsy or Parkinson's disease
  • Current pregnancy or planning pregnancy within 4 months
  • Malignancy (cancer)
  • Professional athletes
  • Workers compensation insurance status due to therapy coverage limitations
  • Enrolled in another interventional clinical study within past 30 days
  • Deemed unsuitable for study participation by investigators
  • Unable to consent or participate due to cognitive or communication impairments

AI-Screening

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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

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Research Team

J

Jenny Hudnall, MS BME

CONTACT

E

Evan Hernandez, MBA

CONTACT

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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