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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04390035
The ClinicalTrials.gov registry entry for NCT04390035 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (11% lower). The listed sponsor is Children's Healthcare of Atlanta, which has 80 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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