Blood Flow Restriction Training After ACL Reconstruction in Adolescents

This study is looking at how blood flow restriction training (BFRT) affects adolescents aged 12-18 who have had anterior cruciate ligament reconstruction (ACLR) surgery. Participants will be assigned to either receive BFRT using the Delfi Personalized Tourniquet System or standard physical therapy. The BFRT group will train two days a week for 16 weeks, starting 1-2 weeks after surgery. Researchers want to see if BFRT improves quadriceps (thigh muscle) strength, overall function, and quality of life, and how well patients tolerate the training. The study aims to enroll 120 participants and is currently unclear about its recruitment status.

Study design
This is an interventional study that will involve 120 participants. It compares blood flow restriction training to standard physical therapy.
What's involved
Participants will undergo physical therapy sessions twice a week for 16 weeks. Measurements of strength, quality of life, and overall function will be taken regularly.
Compensation
Not stated in the trial record.
Follow-up
Quadriceps strength will be measured up to 24 weeks post-surgery. Hop test and Y-balance test results will be measured at 24 weeks.

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NCT04390035

BFRT in Adolescents After ACL Reconstruction

Recruiting
NAAges 12–18InterventionalTreatment
Children's Healthcare of Atlanta
~120 participants
Updated 2021-08-02 on ClinicalTrials.gov
What's tested:Blood Flow Restriction using Delfi Personalized Tourniquet System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quadriceps Strength
Measured over 0-24 weeks post-surgery
+2 more outcomes measured
Anterior Cruciate Ligament Rupture

NCT04390035

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Healthcare of Atlanta Physical Therapy

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jeanne Graf, PT, DPT, ATC · PRINCIPAL_INVESTIGATOR · Clinical Site Supervisor, Physical Therapist

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Eligibility criteria

Exclusion

Attend first PT visit (PTV) within 5 days post-surgery
Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery
  • Quadriceps Strength0-24 weeks post-surgery

    Quadriceps strength will be evaluated throughout the study using handheld dynamometry and percentage improvement will be compared between the control group and intervention group.

  • Hop Test Results24 weeks

    The hop test battery includes four hop tests (single leg hop for distance, triple hop for distance, 6-meter timed hop, triple crossover hop). Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. The test will be performed at 24 weeks post-surgery.

  • Y-Balance Test Results24 weeks

    Symmetry of performance between operative and non-operative lower extremity will be compared between control group and intervention group. This test will be performed at 24 weeks post-surgery.