Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood flow restriction
Sponsored by
About this trial
This is an interventional basic science trial for Anterior Cruciate Ligament Tear
Eligibility Criteria
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
Sites / Locations
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Anterior cruciate ligament reconstruction group
Control group
Arm Description
Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery
Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries
Outcomes
Primary Outcome Measures
Knee Flexion
Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Knee Internal Rotation
Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Knee Varus
Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Hip Flexion
Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Hip Adduction
Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Hip Internal Rotation
Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
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
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
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
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.
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
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
Secondary Outcome Measures
Exercise Difficulty Score
Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty
Exercise Discomfort Score
Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort
Full Information
NCT ID
NCT04635579
First Posted
November 2, 2020
Last Updated
February 3, 2022
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT04635579
Brief Title
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Official Title
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
November 2, 2020 (Actual)
Study Completion Date
November 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior cruciate ligament reconstruction group
Arm Type
Experimental
Arm Description
Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries
Intervention Type
Device
Intervention Name(s)
Blood flow restriction
Intervention Description
Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
Primary Outcome Measure Information:
Title
Knee Flexion
Description
Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Knee Internal Rotation
Description
Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Knee Varus
Description
Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Hip Flexion
Description
Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Hip Adduction
Description
Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Hip Internal Rotation
Description
Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Time Frame
6 minutes
Title
Knee Extension Moment
Description
Maximum difference in extension moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram
Time Frame
6 minutes
Title
Knee Internal Rotation Moment
Description
Maximum difference in internal rotation moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram
Time Frame
6 minutes
Title
Knee Adduction Moment
Description
Maximum difference in adduction moment of knee while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram
Time Frame
6 minutes
Title
Hip Extension Moment
Description
Maximum difference in extension moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram.
Time Frame
6 minutes
Title
Hip Adduction Moment
Description
Maximum difference in adduction moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram
Time Frame
6 minutes
Title
Hip Internal Rotation Moment
Description
Maximum difference in internal rotation moment of hip while performing exercise between baseline and blood flow restriction condition. Measured in Newton meters per kilogram
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Exercise Difficulty Score
Description
Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty
Time Frame
6 minutes
Title
Exercise Discomfort Score
Description
Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort
Time Frame
6 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Telfer, EngD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available to researchers on request. Dataset includes all kinematic, kinetic and patient reported data.
IPD Sharing Time Frame
11/19/2021 - 11/18/2026
Learn more about this trial
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
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