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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anterior Cruciate Ligament (ACL) RuptureBlood Flow Restriction using Delfi Personalized Tourniquet System - Device
Eligibility
12 - 18
All Sexes
What conditions do you have?
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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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: At time of enrollment and 6, 12, and 24 weeks post-surgery

0-16 weeks post-surgery
Discomfort during BFRT via Visual Analogue Scale
Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale.
0-24 weeks post-surgery
Quadriceps Strength
24 weeks
Hop Test Results
Y-Balance Test Results
Week 24
Quality of life via Lysholm Knee Scale Score

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Test (BFRT)
1 of 2

Active Control

Experimental Treatment

120 Total Participants · 2 Treatment Groups

Primary Treatment: Blood Flow Restriction using Delfi Personalized Tourniquet System · No Placebo Group · N/A

Test (BFRT)
Device
Experimental Group · 1 Intervention: Blood Flow Restriction using Delfi Personalized Tourniquet System · Intervention Types: Device
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at time of enrollment and 6, 12, and 24 weeks post-surgery

Who is running the clinical trial?

Children's Healthcare of AtlantaLead Sponsor
159 Previous Clinical Trials
48,132 Total Patients Enrolled
Jeanne Graf, PT, DPT, ATCPrincipal InvestigatorClinical Site Supervisor, Physical Therapist

Eligibility Criteria

Age 12 - 18 · All Participants · 5 Total Inclusion Criteria

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