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

NCT05596162 | Withdrawn DMC

• 1 other identifier: 220838
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprain 1St Degree; Ankle Sprain 2Nd Degree; Musculoskeletal Injury

Keywords

blood flow restriction; ankle sprain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain Level

  Initial visit & 1, 2, 4, and 8 weeks after the initial visit

• Range of Motion

  Initial visit & 1, 2, 4, and 8 weeks after the initial visit

• Strength Testing

  Initial visit & 1, 2, 4, and 8 weeks after the initial visit

• The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score

  Initial visit & 1, 2, 4, and 8 weeks after the initial visit

• Foot and Ankle Outcome Score (FAOS) Patient-Reported Score

  Initial visit & 1, 2, 4, and 8 weeks after the initial visit

Study Arms (2)

Blood Flow Restriction Group

EXPERIMENTAL

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.

Other: Blood Flow Restriction Therapy

Non-Blood Flow Restriction Group

ACTIVE COMPARATOR

This group will perform the same exercises for the same volume without the use of BFR.

Other: Standard Physical Therapy

Interventions

Blood Flow Restriction Therapy OTHER

Exercise with Blood Flow Restriction

Blood Flow Restriction Group

Standard Physical Therapy OTHER

Exercise without Blood Flow Restriction

Non-Blood Flow Restriction Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will include English speaking student athletes aged 18 and older with clinical diagnosis of an isolated grade I or II lateral ankle sprain

You may not qualify if:

• History of DVT/PE, clotting disordered, peripheral arterial disease, hypertension (BP\>140/90), coronary artery disease, or pregnancy

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

VUMC

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Ankle Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will not be aware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery, Division of Sports Medicine

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 27, 2022
• Study Start: October 17, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)