The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the feasibility of implementing BFR in the rehabilitation treatment of isolated ankle sprains as well as to evaluate the clinical benefits of BFR when compared to standard treatment. This study will evaluate the efficacy of using BFR therapy for the treatment of acute grade I and II ankle sprains. The investigators will evaluate clinical outcomes of range of motion (ROM) and strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. This will be a small, randomized control trial study. The investigators will enroll a total of 40 participants, 20 participants will undergo standard physical therapy for isolated lateral ankle sprains and 20 participants will undergo BFR therapy for an isolated lateral ankle sprain. Patients will be randomized into control and experimental group via block randomization.

Official Title
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The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains

Conditions
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Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Musculoskeletal Injury

Intervention / Treatment
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* Other: Blood Flow Restriction Therapy
* Other: Standard Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain Exclusion Criteria: History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP>140/90), coronary artery disease, or pregnancy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Flow Restriction Group<br>Patient specific tourniquet settings to achieve 80% occlusion. Weight- 20% of 1 rep max, 4 sets 30-15-15-15 reps with 30 second rests between sets Exercises: The first phase will focus on active and passive range of motion of the ankle as well as non-weighted concentric exercises. Phase two will progress with gastrocnemius and soleus stretches along with body weight and light resistance band concentric and eccentric exercises focusing on posterior, anterior and lateral muscle groups of the lower limb. Phase three will introduce weighted, dynamic and proprioceptive exercises. | Other: Blood Flow Restriction Therapy<br>* Exercise with Blood Flow Restriction<br>|
| Active Comparator: Non-Blood Flow Restriction Group<br>This group will perform the same exercises for the same volume without the use of BFR. | Other: Standard Physical Therapy<br>* Exercise without Blood Flow Restriction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Return to Play | Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer. | From Time of Injury to 8 weeks after Injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Level | Pain will be assessed with the Visual Analog Pain Scale (VAS). The minimum and maximum scores are 0 and 10 respectively with higher scores meaning a worse outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | 
| Range of Motion | Range of motion of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 360 with higher scores meaning a worse outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | 
| Strength Testing | Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | 
| The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score | The Foot and Ankle Ability Measure (FAAM) will be used to measure self-reported physical function. It will be measured from 0 to 116 with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | 
| Foot and Ankle Outcome Score (FAOS) Patient-Reported Score | The Foot and Ankle Outcome Score (FAOS) will be used to measure self-reported physical function. It will be measured from 0 to 100% with higher scores meaning a better outcome. | Initial visit & 1, 2, 4, and 8 weeks after the initial visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction, ankle sprain