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

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Fracture of Foot

Treatments: Procedure: BFR+NMES at sub therapeutic level; Procedure: BFR+NMES at therapeutic level

Study type: Interventional

Funder types: Other

Identifiers

NCT05844280

IRB-300009735

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control Group

Active Comparator group

Description:

receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels

Treatment:

Procedure: BFR+NMES at sub therapeutic level

Treatment Group

Experimental group

Description:

receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic

Treatment:

Procedure: BFR+NMES at therapeutic level