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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fracture of Foot

Intervention / Treatment
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* Procedure: BFR+NMES at therapeutic level
* Procedure: BFR+NMES at sub therapeutic level


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels | Procedure: BFR+NMES at sub therapeutic level<br>* This means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise<br>|
| Experimental: Treatment Group<br>receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic | Procedure: BFR+NMES at therapeutic level<br>* This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess for calf muscle atrophy as measured by calf circumference | Calf circumference will be measured using a measuring tape | 2 weeks postop | 
| Assess for calf muscle atrophy as measured by hand held dynamometry | Hand held Dynamometry will be used to measure the length-tension relationship of the muscle in pounds | 2 weeks postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale. | The Visual Analogue Pain Scale is used during the beginning, midpoint, and end of a session. This scale ranges from 0-10 which 0 being no pain and 10 being worst pain | 2 weeks postop | 
| Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f | The Borg Rating of Perceived Exertion will be used for each session and exercise. This rating ranges from 6-20 with 6 being no exertion at all, and 20 being maximum effort | 2 weeks postop |