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

Not Applicable

Withdrawn

• Conditions: Ankle Sprain 2Nd Degree; Musculoskeletal Injury; Ankle Sprain 1St Degree
• Interventions: Other: Standard Physical Therapy; Other: Blood Flow Restriction Therapy

• Registration Number: NCT05596162
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-16
• Study Start: 2022-10-17
• Study First Submitted QC: 2022-10-23
• Study First Posted: 2022-10-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Blood Flow Restriction Group	Standard Physical Therapy	This group will perform the same exercises for the same volume without the use of BFR.
Blood Flow Restriction Group	Blood Flow Restriction Therapy	1. Patient specific tourniquet settings to achieve 80% occlusion. 2. Weight- 20% of 1 rep max, 4 sets 30-15-15-15 reps with 30 second rests between sets 3. 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.

Primary Outcome Measures

Name	Time	Method
Time to Return to Play	From Time of Injury to 8 weeks after Injury	Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer.

Secondary Outcome Measures

Name	Time	Method
The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score	Initial visit & 1, 2, 4, and 8 weeks after the initial visit	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.
Range of Motion	Initial visit & 1, 2, 4, and 8 weeks after the initial visit	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.
Pain Level	Initial visit & 1, 2, 4, and 8 weeks after the initial visit	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.
Strength Testing	Initial visit & 1, 2, 4, and 8 weeks after the initial visit	Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome.
Foot and Ankle Outcome Score (FAOS) Patient-Reported Score	Initial visit & 1, 2, 4, and 8 weeks after the initial visit	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.

Trial Locations

Locations (1)

VUMC; 🇺🇸 Nashville, Tennessee, United States