RECRUITING

BFRT in Adolescents After ACL Reconstruction

Conditions

Anterior Cruciate Ligament Rupture Adolescents Blood Flow Restriction Training Patient-reported Outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-09-23

Study Completion:2023-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04390035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Adolescent male and female patients, age 12-18 2. Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children. 3. Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA 4. Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature. 5. English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.	1. Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging 2. Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction) 3. History of previous knee surgery 4. History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins) 5. ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting 6. Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements) 7. Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection 8. Failure to adhere to attendance requirements as detailed below: * Attend first PT visit (PTV) within 5 days post-surgery * Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery

Inclusion Criteria

Exclusion Criteria

1. Adolescent male and female patients, age 12-18
2. Skeletally mature at time of diagnosis, with closed growth plates, as determined via standard clinic x-ray imaging (this specification automatically excludes pre-pubescent children.
3. Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
4. Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
5. English-speaking adolescents and parents of all races and ethnicities (after preliminary data is achieved, PI will coordinate a larger multi-center study that will include all non-English speaking participants.

1. Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
2. Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
3. History of previous knee surgery
4. History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
5. ICD-10 diagnosis of bleeding disorder (e.g. hemophilia or blood clotting disorder) or use of anticoagulants or other medications that may affect blood clotting
6. Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
7. Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
8. Failure to adhere to attendance requirements as detailed below:
* Attend first PT visit (PTV) within 5 days post-surgery
* Attend a minimum of 20 total PTVs during weeks 1-16 post-surgery

Contacts and Locations

Study Contact

Jeanne Graf, PT, DPT, ATC

CONTACT

404-785-8421

jeannie.graf@chao.org

Principal Investigator

Jeanne Graf, PT, DPT, ATC

PRINCIPAL_INVESTIGATOR

Clinical Site Supervisor, Physical Therapist

Study Locations (Sites)

Children's Healthcare of Atlanta Physical Therapy

Atlanta, Georgia, 30342-3269

United States

Collaborators and Investigators

Sponsor: Children's Healthcare of Atlanta

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-23

Study Completion Date2023-04

Study Record Updates

Study Start Date2020-09-23

Study Completion Date2023-04

Terms related to this study

Keywords Provided by Researchers

Adolescents
Blood Flow Restriction Training
Patient-reported Outcomes

Additional Relevant MeSH Terms

Anterior Cruciate Ligament Rupture