Blood Flow Restriction Group for Ankle Sprain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ankle Sprain+2 MoreBlood Flow Restriction Therapy - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Ankle Sprain
  • Musculoskeletal Injuries

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Initial visit & 1, 2, 4, and 8 weeks after the initial visit

Week 8
Time to Return to Play
Week 8
Ankle
Pain Level
Range of Motion
Strength Testing
The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score

Trial Safety

Trial Design

2 Treatment Groups

Non-Blood Flow Restriction Group
1 of 2
Blood Flow Restriction Group
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Blood Flow Restriction Group · No Placebo Group · N/A

Blood Flow Restriction Group
Other
Experimental Group · 1 Intervention: Blood Flow Restriction Therapy · Intervention Types: Other
Non-Blood Flow Restriction Group
Other
ActiveComparator Group · 1 Intervention: Standard Physical Therapy · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: initial visit & 1, 2, 4, and 8 weeks after the initial visit

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
774 Previous Clinical Trials
598,294 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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