Skip to main content
OpenTrials
Completed

NCT Number: NCT04635579

Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Medical Center

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(ACL-R group):

  • 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

Treatment and study plan

Blood Flow Restriction

Device

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

Primary outcomes

  1. Knee Flexion

    Time frame: 6 minutes

    Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  2. Knee Internal Rotation

    Time frame: 6 minutes

    Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  3. Knee Varus

    Time frame: 6 minutes

    Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  4. Hip Flexion

    Time frame: 6 minutes

    Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  5. Hip Adduction

    Time frame: 6 minutes

    Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  6. Hip Internal Rotation

    Time frame: 6 minutes

    Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees

  7. Knee Extension Moment

    Time frame: 6 minutes

    Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

  8. Knee Internal Rotation Moment

    Time frame: 6 minutes

    Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

  9. Knee Adduction Moment

    Time frame: 6 minutes

    Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

  10. Hip Extension Moment

    Time frame: 6 minutes

    Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram.

  11. Hip Adduction Moment

    Time frame: 6 minutes

    Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

  12. Hip Internal Rotation Moment

    Time frame: 6 minutes

    Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram

Secondary outcomes

  1. Exercise Difficulty Score

    Time frame: 6 minutes

    Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty

  2. Exercise Discomfort Score

    Time frame: 6 minutes

    Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.