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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTexas Tech University Health Sciences Center

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • blood flow restriction

Treatment groups

105 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Texas Tech University Health Sciences Center

Lead sponsor

The Center for Orthopedic Surgery

Collaborator

UMC Health System

Collaborator

H2 Health (Physical Therapy Today)

Collaborator

Northstar Surgery Center

Collaborator