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Blood Flow Restriction Following ACL Reconstruction

NCT03758755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2022-12-22

Study results available
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Summary

The main objective is to determine the impact of Blood Flow Restriction (BFR) therapy, in comparison to a standard rehabilitation protocol, on preventing atrophy, improving quadriceps strength and improving functional outcomes of patients recovering from ACL reconstruction. The investigators hypothesize that patients undergoing BFR therapy after ACL reconstruction surgery will have better functional outcomes than those undergoing normal rehabilitation without BFR therapy.

Conditions

  • Anterior Cruciate Ligament Rupture

Interventions

DEVICE

Blood Flow Restriction Therapy

A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.

OTHER

ACL Reconstruction rehabilitation

post-operative rehabilitation according to current standards of care

Sponsors & Collaborators

  • Inova Health Care Services

    lead OTHER

Principal Investigators

  • Edward Chang, MD · Orthopedic Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-11-01
Completion
2022-10-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03758755 on ClinicalTrials.gov