Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2020-11-02

Brief Summary

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This is a cross-sectional study on the use of personalized blood flow restriction during rehabilitation exercises and its effects on biomechanics on people who have had an anterior cruciate ligament reconstruction and healthy controls

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Detailed Description

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Rehabilitation after surgical reconstruction of the anterior cruciate ligament (ACL) aims to reestablish the function of the knee. However, regaining previous levels of strength is challenging, with long-term muscle weakness frequently reported and thought to play a key role in the increased risk of knee osteoarthritis for individuals with a history of ACL damage. Effectively building muscle strength requires exercises with high resistance loads, however the joint stress and risk of further injury makes these types of activities inappropriate and unsafe for those rehabilitating after ACL reconstruction surgery and other injuries. Personalized blood flow restriction (BFR) training is a technique where the blood flow to the muscles being exercised is controlled by a pressure cuff to a predefined level, and has been shown to increase strength while exercising with significantly lower loads. Early results have been promising, however the effects of BFR on the biomechanics of the exercise as well as the acceptability in the ACL reconstruction population have not been explored. In this application, we propose a cross-sectional study designed to test the acceptability of BFR training for those undergoing rehabilitation from ACL reconstruction surgery and healthy controls during free standing exercises. We will also investigate the biomechanical effects of this rehabilitation technique. This application is part of a larger program of musculoskeletal research in this area being developed by the team. The results from the proposed project will inform the design of a clinical trial of personalized BFR after ACL reconstruction.

Conditions

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Anterior Cruciate Ligament Tear

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Anterior cruciate ligament reconstruction group

Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery

Group Type EXPERIMENTAL

Blood flow restriction

Intervention Type DEVICE

Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure

Control group

Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries

Group Type ACTIVE_COMPARATOR

Blood flow restriction

Intervention Type DEVICE

Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure

Interventions

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Blood flow restriction

Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Must be undergoing rehabilitation for anterior cruciate ligament reconstruction surgery
* Must be at least 3 months post surgery.
* Attending clinician should confirm that they are able to take part in the trial

Exclusion Criteria

* Any other orthopaedic, neurological, or other condition within the last 12 months that would affect ability to carry out the required exercises
* Any medical conditions that may affect circulation including, but not limited to, deep vein thrombosis, high blood pressure, and cardiac disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes