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RECRUITING NA

BFRT in Adolescents After ACL Reconstruction

NCT04390035 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE Blood Flow Restriction using Delfi Personalized Tourniquet System

Study Locations (1)

Georgia

  • Children's Healthcare of Atlanta Physical Therapy — Atlanta

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2020-09-23
Est. Completion 2023-04
Phase NA

Sponsor

Children's Healthcare of Atlanta

8 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Healthcare of Atlanta, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04390035 reports 1 study location spanning 1 distinct geographic area — top geographies include Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04390035?

The interventions under investigation include: Blood Flow Restriction using Delfi Personalized Tourniquet System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04390035?

This trial is sponsored by Children's Healthcare of Atlanta, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial