The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754632
• Other study ID #: 22-139
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2023
• Source: Connecticut Children's Medical Center
• Contact: Adam P Weaver, PT, DPT
• Phone: 8602840296
• Email: aweaver[@]connecticutchildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

While there are a number studies that have reported on the use of blood flow restriction training (BFRT) in the adult population, there is limited information about the use of BFRT in the adolescent population. This study aims to evaluate the use of BFRT in conjunction with traditional anterior ligament reconstruction (ACLR) rehabilitation in adolescents.

The purpose of this study is to compare the addition of a BFRT based exercise protocol to a standard ACL rehabilitation protocol in adolescents. Does the addition of BFRT-based exercise improve strength, hypertrophy, and patient reported outcomes after ACLR in the adolescent population?

Description:

A single randomized control trial will compare the use of exercises augmented with BFRT with quantitative measurements of strength and patient-reported outcomes. A total of 40 youth and adolescent patients undergoing a surgical procedure for ACLR and subsequent physical therapy at our institution will be recruited for this study. Patients will be randomized into one of two groups using computer randomization for allocation: the intervention group receiving BFRT as part of physical therapy, and the control group will follow the institution's standard ACLR rehabilitation protocol. Both groups will follow a time- and criterion-based standardized rehabilitation protocol. The primary outcomes will be isometric and isokinetic knee peak torque and limb symmetry indices. Secondary outcomes will be quadriceps hypertrophy via mid-thigh circumference and patient-reported outcomes.

Target Population Adolescent patients between the ages of 12 and 18 will be recruited at the time of surgery, specifically, those that participate in sports who are undergoing primary ACLR reconstruction at Connecticut Children's

Study Group and Control Group Inclusion Criteria

· Prior to surgery participated in > 50 hours/year of level I or II sports as defined by Noyes et al and planned to return to prior level.

Level I Sports (4-7 days/week) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey) Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball, football, soccer, gymnastics, skiing. wrestling) Running, twisting, turning (racquet sports, baseball, hockey)

• Completion of postoperative rehabilitation following standard protocols

• Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Prior to surgery participated in >50 hours/year of level I or II sports as defined by Noyes et al and planned to return to prior level.

Level I Sports (4-7 days/week) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)

• Level II sports (1-3 days/week) Jumping, hard pivoting, cutting (basketball, volleyball,football, soccer, gymnastics, skiing. wrestling)

• Completion of postoperative rehabilitation following standard protocols

• Orthopedic surgical intervention and physical therapy completed at Connecticut Children's.

Exclusion Criteria:

• An additional lower extremity injury at time of knee injury or previous surgical intervention on the knee (ipsilateral and contralateral)

• Multiple ligament ruptures or trauma

• Weight bearing restrictions for greater than 4 weeks after surgery due to concomitant pathology such as meniscal root/radial repair, chondral pathology, or multi-ligament pathology

• Follow-up surgical procedures including, but not limited to, post-operative arthrofibrosis Inability to attend regular physical therapy sessions (=80% of patient treatment sessions and all assessment visits

• Contraindications to performing BFRT including known history of central or peripheral neurologic impairments, cardiac or metabolic condition or history of deep vein thrombosis (DVT).

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Injuries
• Muscular Atrophy
• Quadriceps Muscle Atrophy
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Connecticut Children's Sports Physical Therapy	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center	University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	Active knee range of motion: Knee AROM will be measured in supine position using a goniometer and standardized procedures reported by Norkin and White	Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Primary	Isometric Quad strength Peak Torque	Isometric strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.	Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Primary	Isometric Quadriceps Strength limb symmetry index	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.	Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Primary	Isometric Hamstring Strength Peak Torque	Isometric strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.	Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Primary	Isometric Hamstring Strength Limb Symmetry Index	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.	Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Primary	Isokinetic Quadriceps strength	Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.	Change in strength at 6 months and 9 months post-op
Primary	Isokinetic Quadriceps Strength limb symmetry index	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.	Change in strength at 6 months and 9 months post-op
Primary	Isokinetic Hamstrings Strength	Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.	Change in strength at 6 months and 9 months post-op
Primary	Isokinetic Hamstring Strength limb symmetry index	Hamstring 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.	Change in strength at 6 months and 9 months post-op
Secondary	Quadriceps Hypertrophy	Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity	Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
Secondary	Pediatric International Knee Documentation Committee	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).	Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Secondary	Knee Outcomes and Osteoarthritis Scale	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	Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Secondary	Anterior Cruciate Ligament- Return to Sport after Injury	Patient Reported Outcome Measure- The scores range from 0 to 100, with higher scores representing patients who are more ready to return to sport	Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Secondary	Tegner Activity Scale	Tegner activity scale will measure sport level- higher level equals higher sport competitive level	changes from pre-operative, 9 months, and 2 years post-operative