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Trial record 2 of 84 for:    blood flow restriction

Blood Flow Restriction Training (BFR) in an Adolescent Population

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ClinicalTrials.gov Identifier: NCT04285879
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Adam Weaver, Connecticut Children's Medical Center

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?


Condition or disease Intervention/treatment Phase
Blood Flow Restriction ACL Tear ACL Injury Device: Blood Flow Restriction using Delfi Personalized Tourniquet System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Determination of Efficacy and Therapeutic Benefits of Blood Flow Restriction Training in an Adolescent Population
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : January 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: BFR Exercise Group

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

No Intervention: Non-BFR exercise group
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



Primary Outcome Measures :
  1. Isometric Quad strength Peak Torque [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Isometric strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  2. Isometric Quad Strength limb symmetry index [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Quadriceps limb symmetry index is calculated by taking the values from outcome 1. [ ( peak torque quadriceps involved limb (ft/lbs)/ peak torque quadriceps uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry.

  3. Isometric hamstring Strength Peak Torque [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Isometric strength testing to measure peak torque hamstsring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.

  4. Isometric Hamstring Strength Limb Symmetry Index [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Hamstring limb symmetry index is calculated by taking the values from outcome 3 [ ( peak torque hamstring involved limb (ft/lbs) / peak torque hamstring uninvolved limb (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal perfect symmetry.

  5. Isometric Hip Extension Strength Peak Torque [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Isometric strength testing to measure peak torque hip extension in foot pounds as reported by isokinetic dynamometer

  6. Isometric hip extension Strength Limb Symmetry Index [ Time Frame: Change in strength at Pre-op, 3months post-op, 6-9 months post-op ]
    Hip Extension limb symmetry index is calculated by taking the values from outcome 5 [ ( peak torque hip extension involved limb peak torque (ft/lbs) /hip extension uninvolved limb peak torque (ft-lbs))*100] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal perfect symmetry.

  7. Anterior step down test [ Time Frame: Change in strength from 3months post-op, 6-9 months post-op ]
    Anterior step down test measured in number of repetitions comparing involved to uninvolved lower extremity

  8. Y balance test [ Time Frame: Change in strength from 3months post-op, 6-9 months post-op ]
    Y balance test measuring distance of excursion in cm compared comparing involved to uninvolved lower extremity

  9. Lower Extremity Strength [ Time Frame: Change in strength from 3months post-op, 6-9 months post-op ]
    Single leg Bridge test measured in number of repetitions side to side

  10. Single Leg Hop Test Distance [ Time Frame: 6-9 months post-op ]
    Single Leg Hop Test measured in cm for involved and uninvolved limb.

  11. Single Leg Hop Test Distance Symmetry [ Time Frame: 6-9 months post-op ]
    Single Leg Hop Test measured in cm for involved and uninvolved limbs. Limb symmetry index is calculated by using the distance for involved and uninvolved [ ( involved limb distance / uninvolved limb distance)*100]. this value is expressed as a percentage. 100% would equal perfect symmetry.

  12. 6 meter timed single leg hop [ Time Frame: 6-9 months post-op ]
    Timed 6 meter single leg hop for involved and uninvolved limb measured in seconds.

  13. 6meter timed hop symmetry [ Time Frame: 6-9 months post-op ]
    Timed 6m single leg hop calculating limb symmetry index [ ( involved limb single leg hop time/ uninvolved single leg hop time)*100]. This value is expressed as a percentage. 100% would equal perfect symmetry.

  14. Single Leg Triple hop for distance [ Time Frame: 6-9 months post-op ]
    Triple Hop Test measured in cm for involved and uninvolved limb,

  15. Single Leg Triple Hop Symmetry [ Time Frame: 6-9 months post-op ]
    Single Leg Triple hop calculating limb symmetry index [ ( involved limb triple hop distance/ uninvolved triple hop distance)*100]. This value is expressed as a percentage. 100% would equal perfect symmetry.

  16. Single Leg Crossover hop for distance [ Time Frame: 6-9 months post-op ]
    Single leg Crossover hop Test measured in cm for involved and uninvolved limb.

  17. Single Leg Crossover Hop Symmetry [ Time Frame: 6-9 months post-op ]
    Single Leg Crossover Hop calculating limb symmetry index [ ( involved limb crossover hop distance/ crossover triple hop distance)*100]. This value is expressed as a percentage. 100% would equal perfect symmetry.


Secondary Outcome Measures :
  1. Quad Hypertrophy [ Time Frame: Tracking change at Pre-op, 3months post-op, 6-9 months post-op ]
    Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity

  2. Pedi-IKDC (International Knee Documentation Committee) [ Time Frame: And tracking change at Pre-op, 3months post-op, 6-9 months post-op ]
    Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  3. KOOS (Knee Outcomes and Osteoarthritis Scale) [ Time Frame: Tracking change at Pre-op, 3months post-op, 6-9 months post-op ]
    Patient Reported Outcome Measure- The score is a percentage score from 0 to 100, with 0 representing extreme problems and 100 representing no problems. This scoring direction, 100 indicating no problems

  4. ACL- RSI (Anterior Cruciate Ligament- Return to Sport after Injury) [ Time Frame: Tracking change at Pre-op, 3months post-op, 6-9 months post-op ]
    Patient Reported Outcome Measure- ACL-RSI scores range from 0 to 100, with higher scores representing patients who are more ready to return to sport

  5. Marx Activity Rating Scale [ Time Frame: Tracking change at Pre-op, 3months post-op, 6-9 months post-op ]
    Patient Reported Outcome Measure- This determines a patient's activity level as it pertains to running, cutting, deceleration and pivoting. A higher score indicates a higher activity level (0-16 max)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • Patients with weight bearing restrictions for greater than two weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology. . Generic exclusion: "Subjects not meeting all inclusion criteria."

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285879


Contacts
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Contact: Adam P Weaver, PT, DPT 860-284-0246 ext 79296 aweaver@connecticutchildrens.org
Contact: Art Fredericks, MSPT 860-284-0246 ext 79296 afredericks@connecticutchildrens.org

Locations
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United States, Connecticut
Connecticut Children's Sports Physical Therapy Recruiting
Farmington, Connecticut, United States, 06032
Contact: Adam P Weaver, PT, DPT    860-284-0246 ext 79296    aweaver@connecticutchildrens.org   
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
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Principal Investigator: Adam Weaver, PT, DPT Physical Therapist
  Study Documents (Full-Text)

Documents provided by Adam Weaver, Connecticut Children's Medical Center:
Study Protocol  [PDF] December 9, 2019

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Responsible Party: Adam Weaver, Physical Therapist, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT04285879    
Other Study ID Numbers: 19-168
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Adam Weaver, Connecticut Children's Medical Center:
physical therapy
rehabilitation
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries