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Clinical Trials/NCT05844280
NCT05844280
Withdrawn
Not Applicable

The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

University of Alabama at Birmingham0 sites28 target enrollmentAugust 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fracture of Foot
Sponsor
University of Alabama at Birmingham
Enrollment
28
Primary Endpoint
Assess for calf muscle atrophy as measured by calf circumference
Status
Withdrawn
Last Updated
last year

Overview

Brief Summary

The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.

Detailed Description

Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age \>= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.

Registry
clinicaltrials.gov
Start Date
August 2026
End Date
December 2029
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Johnson

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

  • isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

Exclusion Criteria

  • history of Deep Vein Thrombosis in affected extremity
  • history of significant cardiac disease defined as a recent stent placement in past
  • history of peripheral arterial disease
  • history of sickle cell disease
  • history of coagulopathy
  • presenting to surgery \>14 days after injury

Outcomes

Primary Outcomes

Assess for calf muscle atrophy as measured by calf circumference

Time Frame: 2 weeks postop

Calf circumference will be measured using a measuring tape

Assess for calf muscle atrophy as measured by hand held dynamometry

Time Frame: 2 weeks postop

Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds

Secondary Outcomes

  • Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.(2 weeks postop)
  • Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f(2 weeks postop)

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