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

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.

Study Overview

• Status: Recruiting
• Conditions: Musculoskeletal Injury; Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree
• Intervention / Treatment: Other: Blood Flow Restriction Therapy; Other: Standard Physical Therapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric N Bowman, MD; Phone Number: (615) 936-3391; Email: eric.n.bowman@vumc.org
• Study Contact Backup: Name: Veera Venkata Naga Manohar Devarasetty, BS

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • VUmc
      • Contact: Eric N Bowman; Phone Number: 615-936-3391; Email: eric.n.bowman@vumc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-Blood Flow Restriction Group; This group will perform the same exercises for the same volume without the use of BFR.	Other: Standard Physical Therapy; Exercise without Blood Flow Restriction
Experimental: Blood Flow Restriction Group; 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; Exercise with Blood Flow Restriction

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: ankle sprain; blood flow restriction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Sprains and Strains; Ankle Injuries
• Other Study ID Numbers: 220838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No