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Blood Flow Restriction using Delfi Personalized Tourniquet System for Anterior Cruciate Ligament Rupture

N/A

Waitlist Available

Led By Jeanne Graf, PT, DPT, ATC

Research Sponsored by Children's Healthcare of Atlanta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at time of enrollment and 6, 12, and 24 weeks post-surgery

Awards & highlights

Study Summary

This trial is studying the effects of blood flow restriction training (BFRT) on adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study will identify the effect of BFRT on quadriceps muscle strength and the patient's quality of life, and the overall tolerability of BFRT will be examined.

Eligible Conditions

Anterior Cruciate Ligament (ACL) Rupture

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at time of enrollment and 6, 12, and 24 weeks post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at time of enrollment and 6, 12, and 24 weeks post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at time of enrollment and 6, 12, and 24 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hop Test Results

Quadriceps Strength

Y-Balance Test Results

Secondary outcome measures

Discomfort during BFRT via Visual Analogue Scale

Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale.

Quality of life via Lysholm Knee Scale Score

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Test (BFRT)Experimental Treatment1 Intervention

Participants in the test arm will follow the identical physical therapy exercises as the control arm but will perform the exercises with BFRT during the first 16 weeks post-surgery. After reaching the 16-week mark, participants will complete the identical standard-of-care rehabilitation between weeks 16-24.

Group II: ControlActive Control1 Intervention

Participants in the control arm will follow the standard-of-care treatment exercises for the 6 months following ACL reconstruction surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Flow Restriction using Delfi Personalized Tourniquet System

2020

N/A

~50

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Who is running the clinical trial?

Children's Healthcare of AtlantaLead Sponsor

165 Previous Clinical Trials

105,010 Total Patients Enrolled

Jeanne Graf, PT, DPT, ATCPrincipal InvestigatorClinical Site Supervisor, Physical Therapist

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment open to individuals above the age of 65 for this trial?

"As outlined by the requirements for participation, only individuals aged 12 to 18 can register for this medical experiment."

Answered by AI

How many research subjects are participating in this investigation?

"Affirmative. On clinicaltrials.gov, we can observe that recruitment for this medical trial is still ongoing; it was initially posted on September 23rd 2020 and has been updated as recently as July 27th 2021. The study requires a total of 120 participants from one site to be enrolled in the experiment."

Answered by AI

For whom is this research study open to enrollment?

"This study is taking onboard 120 adolescents aged 12-18 suffering from rupture. Male and female participants must be skeletally mature, which precludes prepubescent children, as determined by x-rays. Additionally, these tweens/teens need to have completed a strength assessment of their quads, hamstrings, hip abductors and adductors in advance."

Answered by AI

Is enrollment for this clinical experiment still open?

"Affirmative. Per the clinicaltrials.gov records, this medical trial is currently recruiting candidates since it was first uploaded on September 23rd 2020 and last revised on July 27th 2021. This study seeks 120 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BFRT in Adolescents After ACL Reconstruction

Jeanne Perkis 2020. "BFRT in Adolescents After ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04390035.