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Blood Flow Restriction Therapy for Ankle Sprains

N/A

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will evaluate the effectiveness of blood flow restriction therapy on ankle injuries. 40 participants will use traditional therapy and BFR therapy to compare results.

Who is the study for?

This trial is for English-speaking student athletes over 18 with a mild to moderate ankle sprain (grade I or II). It's not suitable for those with blood clots, clotting disorders, artery diseases, high blood pressure (>140/90), heart disease, or if pregnant.Check my eligibility

What is being tested?

The study compares low-intensity Blood Flow Restriction (BFR) Therapy against standard physical therapy in treating acute ankle sprains. Participants will be randomly assigned to one of the two treatments and their range of motion and strength will be measured.See study design

What are the potential side effects?

While specific side effects are not listed here, BFR therapy generally may cause discomfort due to restricted blood flow. Standard physical therapy risks include muscle soreness and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an English-speaking student athlete over 18 with a mild to moderate ankle sprain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of injury to 8 weeks after injury

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of injury to 8 weeks after injury

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of injury to 8 weeks after injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Return to Play

Secondary outcome measures

Ankle

Pain Level

Range of Motion

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blood Flow Restriction GroupExperimental Treatment1 Intervention

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.

Group II: Non-Blood Flow Restriction GroupActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,153 Total Patients Enrolled

Media Library

Blood Flow Restriction Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05596162 — N/A

Ankle Sprain Research Study Groups: Blood Flow Restriction Group, Non-Blood Flow Restriction Group

Ankle Sprain Clinical Trial 2023: Blood Flow Restriction Therapy Highlights & Side Effects. Trial Name: NCT05596162 — N/A

Blood Flow Restriction Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05596162 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this clinical trial currently ongoing?

"Affirmative, the information posted to clinicaltrials.gov reveals that this trial is presently seeking participants. This research was created on October 17th 2022 and renewed on October 23rd of the same year. 40 volunteers are needed from one medical site to join in the study."

Answered by AI

What is the upper limit on participants for this experiment?

"Affirmative. Clinicaltrials.gov contains information that confirms this medical investigation is currently recruiting patients, with the trial first posted on October 17th 2022 and most recently updated on October 23rd 2022. 40 individuals are required for participation at a single research centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Eric N. Bowman 2022. "The Effect of Low-Intensity Blood Flow Restriction Therapy on the Management of Acute Ankle Sprains". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05596162.