Phase None Recruiting NCT04390035

Blood Flow Restriction Training in the Adolescent Patient: Effects on Muscle Strength and Overall Function Following Anterior Cruciate Ligament Reconstruction Surgery

Children's Healthcare of Atlanta · Interventional, Randomized · n=120

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Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT04390035).

Eligibility

Age range: 12–18 · Sex: All · Healthy volunteers: Accepts

Study design

Phase
Phase None
Study type
Interventional
Allocation
Randomized
Masking
Open label
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment target
120 participants
Started
September 2020
Estimated completion
April 2023

Outcome measures

Locations & contactsi

Filter by location Showing 1 of 1 sites

1 site currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

Children's Healthcare of Atlanta Physical Therapy — Atlanta, Georgia (United States)

Sources

REG
ClinicalTrials.gov — NCT04390035
Trial registry · primary record
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