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

Sponsor
Vanderbilt University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05596162
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
13.5
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood Flow Restriction Therapy
  • Other: Standard Physical Therapy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The assessors will not be aware of group allocation.
Primary Purpose:
Treatment
Official Title:
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Actual Study Start Date :
Oct 17, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 VUMC Nashville Tennessee United States 37232

Sponsors and Collaborators

  • Vanderbilt University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eric N. Bowman, Assistant Professor of Orthopaedic Surgery, Division of Sports Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT05596162
Other Study ID Numbers:
  • 220838
First Posted:
Oct 27, 2022
Last Update Posted:
Oct 27, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eric N. Bowman, Assistant Professor of Orthopaedic Surgery, Division of Sports Medicine, Vanderbilt University Medical Center
blood flow restriction
ankle sprain
Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries

Study Results

No Results Posted as of Oct 27, 2022