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

NCT ID: NCT05844280

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2026-08-31

Study Completion Date

2029-12-31

Brief Summary

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The purpose of the study is to determine the role of blood flow restriction (BFR) + neuromuscular electrical stimulation (NMES) in improving post-operative physical therapy and recovery after ankle fracture surgery. We expect to see improved muscle strength, less muscle wasting, and improved functional recovery after surgery when making these additions to routine post-operative (postop) physical therapy protocols.

Detailed Description

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Few studies have examined BFR in patients sustaining operative foot and ankle injuries. Due to the weight bearing limitations and prolonged immobilization following these injuries, patients often experience increased time away from work and delays with return to sport. These factors are responsible for the rapid muscle atrophy that occurs in the immediate post injury period because of immobility and disuse. Recently, blood flow restriction (BFR) therapy has been shown to be effective in improving muscle strength and preventing atrophy when combined with low load resistance training physical therapy programs.7,8 Neuromuscular electrical stimulation (NMES) is an adjunctive agent that has been show to augment the effects of BFR alone.4 The null hypothesis is that a 2 week BFR + NMES + low load resistance training program in patients age \>= 18 recovering from foot and ankle surgery will have no effect on short term (2 weeks postop) lower extremity muscle hypertrophy or atrophy, patient pain and satisfaction, or functional recovery after foot and ankle surgery.

Conditions

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Fracture of Foot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type ACTIVE_COMPARATOR

BFR+NMES at sub therapeutic level

Intervention Type PROCEDURE

This means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise

Treatment Group

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

Group Type EXPERIMENTAL

BFR+NMES at therapeutic level

Intervention Type PROCEDURE

This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.

Interventions

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BFR+NMES at therapeutic level

This group will receive therapy with BFR+NMES devices used at settings that are deemed by prior studies to be therapeutic.

Intervention Type PROCEDURE

BFR+NMES at sub therapeutic level

This means that the BFR tourniquet and the NMES device will be at such low settings as to not create the treatment effect but subject will have the equipments on their thigh during exercise

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* isolated, closed low-energy rotational ankle fracture without prior surgery or implants to injured area

Exclusion Criteria

* history of Deep Vein Thrombosis in affected extremity
* history of significant cardiac disease defined as a recent stent placement in past
* history of peripheral arterial disease
* history of sickle cell disease
* history of coagulopathy
* presenting to surgery \>14 days after injury
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Michael Johnson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Countries

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United States

Other Identifiers

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IRB-300009735

Identifier Type: -

Identifier Source: org_study_id