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NCT04390035 · ClinicalTrials.gov registry record · NA
BFRT in Adolescents After ACL Reconstruction
A NA study of Anterior Cruciate Ligament Rupture, sponsored by Children's Healthcare of Atlanta.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04390035: Recruiting NA study of Anterior Cruciate Ligament Rupture, sponsored by Children's Healthcare of Atlanta.
NCT04390035 is a NA study of Anterior Cruciate Ligament Rupture that is actively recruiting participants, run by Children's Healthcare of Atlanta. The registered enrollment target is 120 participants, below the 135-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (11% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04390035, a NA study of Anterior Cruciate Ligament Rupture, is actively recruiting participants, sponsored by Children's Healthcare of Atlanta.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study aims to 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. Eight physical therapists at four sports medicine physical therapy (PT) sites will oversee all post-operative PT sessions. Subjects allocated to the BFR group will undergo BFRT, while control group will undergo standard-of-care ACLR rehabilitation, 2 days per week for 16 weeks. Measurements of strength, quality of life, and overall function will be completed at regular intervals.
Primary Outcome
Quadriceps strength will be evaluated throughout the study using handheld dynamometry and percentage improvement will be compared between the control group and intervention group.
Conditions Studied
Interventions
- DEVICE Blood Flow Restriction using Delfi Personalized Tourniquet System
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta Physical Therapy - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2023-04 |
| Phase | NA |
What NCT04390035 shows while recruiting
NCT04390035 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 135-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Anterior Cruciate Ligament Rupture appearing as the primary indexed condition, and to 1 intervention - of which Blood Flow Restriction using Delfi Personalized Tourniquet System is the first listed.
NCT04390035 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04390035 about?
NCT04390035 is a clinical study titled "BFRT in Adolescents After ACL Reconstruction". This is an interventional study that will examine effects of blood flow restriction training (BFRT) in adolescents aged 12-18 after anterior cruciate ligament reconstruction surgery (ACLR). The study aims to identify the effect of BFRT on quadriceps muscle strength and the patient's quality of life,...
What is the current status of trial NCT04390035?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2020-09-23. Estimated completion is 2023-04.
What conditions does trial NCT04390035 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Rupture.
What interventions are being tested in trial NCT04390035?
The interventions under investigation include: Blood Flow Restriction using Delfi Personalized Tourniquet System (DEVICE).
Who is sponsoring clinical trial NCT04390035?
This trial is sponsored by Children's Healthcare of Atlanta, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04390035 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04390035's enrollment target sits among peer trials
120 5th of 9 higher than 5 of 9 other Anterior Cruciate Ligament Rupture trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Rupture trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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