Clinical trial NCT05754632: The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
Official title: The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Knee Injuries
Quadriceps Muscle Atrophy
Keywords: physical therapy
rehabilitation
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
Collaborators: name: University of Connecticut
First posted: 2023-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

Brief 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?

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Range of Motion
timeFrame: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
measure: Isometric Quad strength Peak Torque
timeFrame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
measure: Isometric Quadriceps Strength limb symmetry index
timeFrame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
measure: Isometric Hamstring Strength Peak Torque
timeFrame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
measure: Isometric Hamstring Strength Limb Symmetry Index
timeFrame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
measure: Isokinetic Quadriceps strength
timeFrame: Change in strength at 6 months and 9 months post-op
measure: Isokinetic Quadriceps Strength limb symmetry index
timeFrame: Change in strength at 6 months and 9 months post-op
measure: Isokinetic Hamstrings Strength
timeFrame: Change in strength at 6 months and 9 months post-op
measure: Isokinetic Hamstring Strength limb symmetry index
timeFrame: Change in strength at 6 months and 9 months post-op
Secondary outcomes:
measure: Quadriceps Hypertrophy
timeFrame: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
measure: Pediatric International Knee Documentation Committee
timeFrame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
measure: Knee Outcomes and Osteoarthritis Scale
timeFrame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
measure: Anterior Cruciate Ligament- Return to Sport after Injury
timeFrame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
measure: Tegner Activity Scale
timeFrame: changes from pre-operative, 9 months, and 2 years post-operative
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Connecticut Children's Sports Physical Therapy
state: Connecticut
Study officials:
affiliation: Physical Therapist
name: Adam Weaver, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: