Anterior Cruciate Ligament TearNCT04635579
Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
A study testing Blood flow restriction in people with Anterior Cruciate Ligament Tear, run by University of Washington at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- Blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 2 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
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
Read the 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.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Blood flow restriction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restrictionDevice
Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
| Study group | Role | What they receive |
|---|---|---|
| Anterior cruciate ligament reconstruction group | Experimental | Single session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery Receives: Device: Blood flow restriction |
| Control group | Active comparator | Single session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries Receives: Device: Blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Flexion
Maximum difference in flexion motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
Knee Internal Rotation
Maximum difference in internal rotation of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
Knee Varus
Maximum difference in varus motion of knee while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
Hip Flexion
Maximum difference in flexion motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
Hip Adduction
Maximum difference in adduction motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
Hip Internal Rotation
Maximum difference in internal rotation motion of hip while performing exercise between baseline and blood flow restriction condition. Measured in degrees
Measured: 6 minutes
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
Measured: 6 minutes
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
Measured: 6 minutes
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
Measured: 6 minutes
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.
Measured: 6 minutes
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
Measured: 6 minutes
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
Measured: 6 minutes
Secondary outcomes (2)
Exercise Difficulty Score
Numerical Analogue Scale, 0-10, higher scores indicate greater difficulty
Measured: 6 minutes
Exercise Discomfort Score
Numerical Analogue Scale, 0-10, higher scores indicate greater discomfort
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start8 May 2018
- Primary completion2 Nov 2020
- Study completion2 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Scott Telfer, EngD, University of Washington
- Investigators
- Scott Telfer, EngD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635579
- Sponsor's protocol ID
- STUDY00004543
- Other IDs
- 5P30AR072572-02
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2020
- Last updated
- 28 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be made available to researchers on request. Dataset includes all kinematic, kinetic and patient reported data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation
- ClinicalTrials.gov ID
- NCT04635579
- Acronym / sponsor ID
- STUDY00004543
- Conditions
- Anterior Cruciate Ligament Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 2 Nov 2020 (actual)
- Study completion
- 2 Nov 2020 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Posted 28 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior cruciate ligament reconstruction group | Experimental | Device: Blood flow restrictionSingle session blood flow restriction of lower limb to individuals who have undergone anterior ligament reconstruction surgery |
| Control group | Active comparator | Device: Blood flow restrictionSingle session blood flow restriction of lower limb to individuals who have no musculoskeletal injuries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restrictionIntervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure | Device | Anterior cruciate ligament reconstruction group, Control group |
Primary outcome
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
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
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
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
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
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
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
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
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
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.
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
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
2 secondary outcomes
Exercise Difficulty Score
Time frame: 6 minutes
Exercise Discomfort Score
Time frame: 6 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be made available to researchers on request. Dataset includes all kinematic, kinetic and patient reported data.
Related trials for Anterior Cruciate Ligament Tear
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
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RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Telfer, EngD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction in people with Anterior Cruciate Ligament Tear, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Flexion (time frame: 6 minutes). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.