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BFR Therapy + NMES for Ankle Injury Recovery

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks postop

Awards & highlights

Study Summary

This trial will measure if adding BFR+NMES to postop PT can improve muscle strength, reduce muscle wasting and improve functional recovery after an ankle fracture surgery.

Who is the study for?

This trial is for individuals with a recent, simple ankle fracture that hasn't had previous surgery or implants. It's designed to see if adding blood flow restriction and electrical muscle stimulation to regular physical therapy after surgery can help patients recover better.Check my eligibility

What is being tested?

The study is testing two levels of neuromuscular electrical stimulation combined with blood flow restriction (BFR) as part of postoperative care: one at therapeutic level and another at sub-therapeutic level, to compare their effects on muscle strength and recovery.See study design

What are the potential side effects?

Potential side effects may include discomfort from the BFR bands or NMES device, skin irritation under electrode placement areas, temporary numbness or tingling in the treated limb, and possible muscle fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks postop for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assess for calf muscle atrophy as measured by calf circumference

Assess for calf muscle atrophy as measured by hand held dynamometry

Secondary outcome measures

Patient tolerance of the BFR treatment using the Visual Analogue Pain Scale.

Patient tolerance of the BFR treatment using the the Borg Rating of Perceived Exertion f

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment1 Intervention

receiving physical therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic

Group II: Control GroupActive Control1 Intervention

receiving physical therapy with BFR+NMES devices used at sub-therapeutic levels

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,016 Total Patients Enrolled

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT05844280 — N/A

Broken Foot Research Study Groups: Control Group, Treatment Group

Broken Foot Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT05844280 — N/A

Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844280 — N/A

Frequently Asked Questions

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

Are participants now being recruited for the research project?

"As indicated on clinicaltrials.gov, this medical trial is no longer actively seeking out candidates. Initially posted August 1st 2023 and last updated May 3rd 2023, the study has concluded recruitment; however, 39 other trials are still in search of participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries

Michael Johnson 2026. "The Role of Blood Flow Restriction Therapy in Postop Rehabilitation of Foot and Ankle Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05844280.