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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction Therapy
Standard Physical Therapy
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain 1St Degree focused on measuring blood flow restriction, ankle sprain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VUMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Flow Restriction Group

Non-Blood Flow Restriction Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
October 16, 2022
Last Updated
October 23, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05596162
Brief Title
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Official Title
The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain 1St Degree, Ankle Sprain 2Nd Degree, Musculoskeletal Injury
Keywords
blood flow restriction, ankle sprain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessors will not be aware of group allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-Blood Flow Restriction Group
Arm Type
Active Comparator
Arm Description
This group will perform the same exercises for the same volume without the use of BFR.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction Therapy
Intervention Description
Exercise with Blood Flow Restriction
Intervention Type
Other
Intervention Name(s)
Standard Physical Therapy
Intervention Description
Exercise without Blood Flow Restriction
Primary Outcome Measure Information:
Title
Time to Return to Play
Description
Time from injury to to when injured ankle regains 90% plantarflexion strength compared to uninjured/contralateral side, using a dynamometer.
Time Frame
From Time of Injury to 8 weeks after Injury
Secondary Outcome Measure Information:
Title
Pain Level
Description
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.
Time Frame
Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Title
Range of Motion
Description
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.
Time Frame
Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Title
Strength Testing
Description
Strength testing of ankle dorsiflexion, plantarflexion, inversion, and eversion. It will be measured from 0 to 5 with higher scores meaning a better outcome.
Time Frame
Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Title
The Foot and Ankle Ability Measure (FAAM) Patient-Reported Score
Description
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.
Time Frame
Initial visit & 1, 2, 4, and 8 weeks after the initial visit
Title
Foot and Ankle Outcome Score (FAOS) Patient-Reported Score
Description
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.
Time Frame
Initial visit & 1, 2, 4, and 8 weeks after the initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric N Bowman, MD
Phone
(615) 936-3391
Email
eric.n.bowman@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Veera Venkata Naga Manohar Devarasetty, BS
Facility Information:
Facility Name
VUMC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric N Bowman
Phone
615-936-3391
Email
eric.n.bowman@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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