BFRT in Adolescents After ACL Reconstruction

NCT04390035 | Recruiting FDA Device

• 1 other identifier: STUDY00000434
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Anterior Cruciate Ligament Rupture

Keywords

Adolescents; Blood Flow Restriction Training; Patient-reported Outcomes

Outcome Measures

Primary Outcomes (3)

• Quadriceps Strength

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

  0-24 weeks post-surgery

• Hop Test Results

  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.

  24 weeks

• Y-Balance Test Results

  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.

  24 weeks

Secondary Outcomes (3)

• Quality of life via Lysholm Knee Scale Score

  At time of enrollment and 6, 12, and 24 weeks post-surgery

• Discomfort during BFRT via Visual Analogue Scale

  0-16 weeks post-surgery

• Perceived Exertion during BFRT via the Children's OMNI Resistance Training Scale.

  0-16 weeks post-surgery

Study Arms (2)

Control

NO INTERVENTION

Participants in the control arm will follow the standard-of-care treatment exercises for the 6 months following ACL reconstruction surgery.

Test (BFRT)

EXPERIMENTAL

Participants in the test arm will follow the identical physical therapy exercises as the control arm but will perform the exercises with BFRT during the first 16 weeks post-surgery. After reaching the 16-week mark, participants will complete the identical standard-of-care rehabilitation between weeks 16-24.

Device: Blood Flow Restriction using Delfi Personalized Tourniquet System

Interventions

Blood Flow Restriction using Delfi Personalized Tourniquet System DEVICE

Participants assigned to the test group will undergo blood flow restriction training 2 days per week beginning at week 1-2 post-surgery and continuing through week 16 post-surgery using the FDA-approved Delfi Personalized Tourniquet System (PTS) with personalized pressure of 80% of the limb occlusion pressure (LOP). The LOP is the amount of pressure required to fully occlude arterial and venous blood flow to the limb. Otherwise, both the test group and control group will follow a standard 6-month post-surgery rehabilitation protocol which is standard of care for ACLR recovery.

Test (BFRT)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent male and female patients, age 12-18
• 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.
• Underwent transphyseal ACLR with quadriceps tendon autograft with one of three sports orthopedic surgeons at CHOA
• Completed pre-surgery strength assessment of bilateral quadriceps, hamstrings, hip abductor and hip adductor musculature.
• 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.

You may not qualify if:

• Skeletally immature patients with open growth plates, as determined via standard clinic x-ray imaging
• Concomitant procedures performed during ACLR which require weight-bearing restrictions (i.e. meniscus repair, microfracture, multi-ligament knee reconstruction)
• History of previous knee surgery
• History of cardiovascular disease (e.g. coronary artery disease, unstable hypertension, vascular endothelial dysfunction, peripheral artery disease, varicose veins)
• 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
• Inability to adhere to treatment protocol (as described in study procedures, BFR-LLT treatment requirements)
• Any adverse events intra-operatively or post-operatively that lead to delay in care, including infection
• 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

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta Physical Therapy

Atlanta, Georgia, 30342-3269, United States

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jeanne Graf, PT, DPT, ATC

  Clinical Site Supervisor, Physical Therapist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanne Graf, PT, DPT, ATC

CONTACT

404-785-8421; jeannie.graf@chao.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given that the intervention involves a device that will be physically applied to the participant's post-operative leg, masking is not feasible for this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Site Supervisor, Physical Therapist

Model Details: Participants will be randomized into either a control group or the test group at time of enrollment at a 1:1 ratio. Participants will undergo standard post-surgery rehabilitation (control group) or standard post-surgery rehabilitation with supplemental blood flow restriction (test group).

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: September 23, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)