Personalized Blood Flow Restriction for Anterior Cruciate Ligament Rehabilitation

NCT04635579 | Completed Results FDA Device

• 2 other identifiers: STUDY000045435P30AR072572-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Anterior Cruciate Ligament Tear

Outcome Measures

Primary Outcomes (12)

• Knee Flexion

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

  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

  6 minutes

• Knee Varus

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

  6 minutes

• Hip Flexion

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

  6 minutes

• Hip Adduction

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

  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

  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

  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

  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

  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.

  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

  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

  6 minutes

Secondary Outcomes (2)

• Exercise Difficulty Score

  6 minutes

• Exercise Discomfort Score

  6 minutes

Study Arms (2)

Anterior cruciate ligament reconstruction group

EXPERIMENTAL

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

Device: Blood flow restriction

Control group

ACTIVE COMPARATOR

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

Device: Blood flow restriction

Interventions

Blood flow restriction DEVICE

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

Anterior cruciate ligament reconstruction group; Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr Scott Telfer
• Organization: University of Washington

telfers@uw.edu

2062292022

Study Officials

• Scott Telfer, EngD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor: School of Medicine

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 19, 2020
• Study Start: May 8, 2018
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: February 28, 2022
• Results First Posted: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: 11/19/2021 - 11/18/2026

Locations

US (1)