Blood Flow Restriction Training (BFR) in an Adolescent Population

NCT04285879 | Completed Results FDA Device

• 1 other identifier: 19-168
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

While there are a number studies that have reported on the use of BFR in the adult population, there is limited information about the use of BFR in the adolescent population. This study aims to evaluate the use of BFR training in conjunction with traditional ACL (anterior cruciate ligament) reconstruction rehabilitation in adolescents. The purpose of this study is to evaluate the addition of BFR-based exercise to traditional methods of physical therapy. Does the use of BFR-based exercise improve strength, hypertrophy, functional and patient reported outcomes after ACL Reconstruction in the adolescent population?

Conditions

Blood Flow Restriction; ACL Tear; ACL Injury

Keywords

physical therapy; rehabilitation

Outcome Measures

Primary Outcomes (4)

• Isometric Quad Strength Peak Torque

  Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

  3 month and return to sport post-operative strength (6-8 months post-op)

• Isometric Quad Strength Limb Symmetry Index

  Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \[ ( peak torque quadriceps involved limb (nm-kg)/ peak torque quadriceps uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry. Should involve limb demonstrate greater strength then uninvolved limb symmetry scores would be greater then 100%

  3 month and return to sport isometric quad strength limb symmetry

• Isometric Hamstring Strength Peak Torque

  Isometric strength testing to measure peak torque hamstring strength (unit:nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

  at 3 months post-op and return to sport (between approximately 6-8 months post-op)

• Isometric Hamstring Strength Limb Symmetry Index

  Hamstring limb symmetry index is calculated by taking the values from outcome 3 \[ ( peak torque hamstring involved limb (nm-kg) / peak torque hamstring uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal symmetry. For patients that demonstrate a stronger involved limb then uninvolved limb symmetry will be reported as greater then 100%

  3 months post op and return to sport (between approximately 6-8 months post-op)

Secondary Outcomes (1)

• Pedi-IKDC (International Knee Documentation Committee)

  at 3 months post-op and return to sport (between approximately 6-8 months post-op)

Study Arms (2)

BFR Exercise Group

EXPERIMENTAL

In addition to the standard ACL protocol, patients in this study will utilize the Owen Recovery Science exercise protocol for BFR \[18\]. The following guidelines will be followed concerning exercise progression, occlusion pressure and difficulties with volume achievement. A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study.

Device: Blood Flow Restriction using Delfi Personalized Tourniquet System

Non-BFR exercise group

NO INTERVENTION

As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine

Interventions

Blood Flow Restriction using Delfi Personalized Tourniquet System DEVICE

The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol

Also known as: FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VAN

BFR Exercise Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between the age of 12 and 18 years at the time of surgery.
• Post-primary ACL reconstruction
• Orthopaedic surgical intervention (including all additional procedures at the knee) completed by one of the Elite Sports Medicine physicians.
• Patient completed postoperative rehabilitation following standard protocols
• No contraindications to performing BFR, as outlined in the Owens Recovery\[18\] Science 2018 Personal Blood Flow Restriction manual.

You may not qualify if:

• Patients older than 18 and younger than 12 at the time of surgery
• Any additional diagnoses or deformity not related to knee injury that could affect knee strength
• Additional lower extremity injury at time of knee injury (e.g., ankle injury) requiring treatment
• Previous surgical intervention on the knee (ipsilateral and contralateral)

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead

Study Sites (1)

Connecticut Children's Sports Physical Therapy

Farmington, Connecticut, 06032, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Limitations and Caveats

Covid-19 pandemic Lost to follow up, surgical exclusion led to small number of controls.

Results Point of Contact

• Title: Adam P. Weaver, PT, DPT
• Organization: Connecticut Children's

Aweaver@connecticutchildrens.org

860-284-0246

Study Officials

• Adam Weaver, PT, DPT

  Physical Therapist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Model Details: The investigators will compare the use of exercises augmented with BFR with quantitative measurements of strength and patient reported outcomes. A total of 20 youth and adolescent patients undergoing a surgical procedure for ACL reconstruction at Connecticut Children's Elite Sports Medicine and completing physical therapy at Connecticut Children's Sports Physical Therapy will be recruited for this study. A review of data from 20 previous patients, matched for age, sex, BMI and surgical procedure that completed physical therapy at Connecticut Children's Sports Physical Therapy will be used as a comparison. As part of this pilot study, the investigators will additionally collect prospective controls. This population will be patients not participating in physical therapy at Connecticut Children's but underwent ACL reconstruction by Elite Sports Medicine.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 26, 2020
• Study Start: December 15, 2020
• Primary Completion: January 15, 2023
• Study Completion: October 16, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)