Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

Anterior Cruciate Ligament Tear Clinical Trial

Official title:

Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635579
• Other study ID #: STUDY00004543
• Secondary ID: 5P30AR072572-02
• Status: Completed
• Phase: N/A
• Start date: May 8, 2018
• Est. completion date: November 2, 2020

Study information

• Verified date: February 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Tear

Intervention

Device:
• Blood flow restriction
Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Flexion	Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Knee Internal Rotation	Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Knee Varus	Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Hip Flexion	Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Hip Adduction	Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Hip Internal Rotation	Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees	6 minutes
Primary	Knee Extension Moment	Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram	6 minutes
Primary	Knee Internal Rotation Moment	Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram	6 minutes
Primary	Knee Adduction Moment	Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram	6 minutes
Primary	Hip Extension Moment	Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram.	6 minutes
Primary	Hip Adduction Moment	Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram	6 minutes
Primary	Hip Internal Rotation Moment	Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram	6 minutes
Secondary	Exercise Difficulty Score	Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty	6 minutes
Secondary	Exercise Discomfort Score	Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort	6 minutes