Blood Flow Restriction Therapy for Postoperative Rehabilitation After Ankle Surgery
(BFRankle recon Trial)
What You Need to Know Before You Apply
What is the purpose of 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).
Who Is on the Research Team?
Jerry Grimes, MD
Principal Investigator
Texas Tech University Health Sciences Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Postoperative Recovery
Participants recover from ankle ligament reconstruction surgery before starting physical therapy
Treatment
Participants receive physical therapy with or without blood flow restriction (BFR) for rehabilitation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Blood Flow Restriction Therapy
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
BFR device added during physical therapy
standard course of physical therapy; no BFR
Find a Clinic Near You
Who Is Running the Clinical Trial?
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
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