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

Musculoskeletal Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596162
• Other study ID #: 220838
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: Eric N Bowman, MD
• Phone: (615) 936-3391
• Email: eric.n.bowman[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain 1St Degree
• Ankle Sprain 2Nd Degree
• Musculoskeletal Injury
• Sprains and Strains

Intervention

Other:
• Blood Flow Restriction Therapy
Exercise with Blood Flow Restriction
• Standard Physical Therapy
Exercise without Blood Flow Restriction

Locations

Country	Name	City	State
United States	VUMC	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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