Anterior Cruciate Ligament InjuriesNCT05754632
The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
A study testing Blood Flow Restriction using Delfi Personalized Tourniquet System in people with Anterior Cruciate Ligament Injuries and Knee Injuries, run by Connecticut Children's Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Knee Injuries, Quadriceps Muscle Atrophy
- What is being tested?
- Blood Flow Restriction using Delfi Personalized Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Sports Physical Therapy
Farmington, Connecticut, 06032
Adam P Weaver, PT, DPT, 860-284-0246 ext. 79296, aweaver@connecticutchildrens.org
About this study
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?
Read the 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.
- Being tested
- Blood Flow Restriction using Delfi Personalized Tourniquet System
- Keywords
- physical therapy, rehabilitation
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction using Delfi Personalized Tourniquet SystemDevice
Also called FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VAN
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.
| Study group | Role | What they receive |
|---|---|---|
| BFR Intervention Group | Experimental | In addition to the standard ACL rehabilitation protocol, the experimental group will complete 2 exercises using the Delfi BFR cuff 2x/week for 8 weeks during their treatment session at Connecticut Children's Sports Physical Therapy on the second post-operative visit. Cuff size will be determined by patient thigh circumference Limb occlusion pressure will be determined in supine position and all exercises will be completed at 80% occlusion.
Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press Receives: Device: Blood Flow Restriction using Delfi Personalized Tourniquet System |
| No Intervention/Control Group | No intervention | In addition to the standard ACL rehabilitation protocol, the control group will complete the same exercises as the experimental group starting on the second post-operative visit. Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Measured: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Measured: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Measured: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 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 (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.
Measured: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
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.
Measured: Change in strength at 6 months and 9 months post-op
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.
Measured: Change in strength at 6 months and 9 months post-op
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.
Measured: Change in strength at 6 months and 9 months post-op
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.
Measured: Change in strength at 6 months and 9 months post-op
Secondary outcomes (5)
Quadriceps Hypertrophy
Thigh Circumference measured at location 10cm superior to patella and measured in cm comparing involved to uninvolved lower extremity
Measured: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
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).
Measured: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
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
Measured: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
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
Measured: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Tegner Activity Scale
Tegner activity scale will measure sport level- higher level equals higher sport competitive level
Measured: changes from pre-operative, 9 months, and 2 years post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start8 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Sponsor
- Investigators
- Adam Weaver, PT, DPT, Principal investigator, Physical Therapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754632
- Sponsor's protocol ID
- 22-139
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2023
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Blood Flow Restriction Training in Adolescents After ACL Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05754632
- Acronym / sponsor ID
- 22-139
- Keywords
- physical therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| BFR Intervention Group | Experimental | Device: Blood Flow Restriction using Delfi Personalized Tourniquet SystemIn addition to the standard ACL rehabilitation protocol, the experimental group will complete 2 exercises using the Delfi BFR cuff 2x/week for 8 weeks during their treatment session at Connecticut Children's Sports Physical Therapy on the second post-operative visit. Cuff size will be determined by patient thigh circumference Limb occlusion pressure will be determined in supine position and all exercises will be completed at 80% occlusion. Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press |
| No Intervention/Control Group | No intervention | –In addition to the standard ACL rehabilitation protocol, the control group will complete the same exercises as the experimental group starting on the second post-operative visit. Long Arc Quadriceps (LAQ) progression Shuttle progression Post-op visit 2- 2 weeks Quadriceps Set Standing Straight Leg Raise 2 weeks-4 weeks Available range LAQ Standing terminal knee extension 4 weeks-8 weeks LAQ (0-90°) Single Limb Shuttle/Leg Press |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow Restriction using Delfi Personalized Tourniquet SystemAlso: FDA Establishment Registration Number 9681444. Device Listing Number E127474. Classification Number 878.5910. Product Code KCY. 510(k) Exempt. MID: XCDELMED1099VANThe 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. | Device | BFR Intervention Group |
Primary outcome
Range of Motion
Time frame: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Active knee range of motion: Knee AROM will be measured in supine position using a goniometer and standardized procedures reported by Norkin and White
Isometric Quad strength Peak Torque
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 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.
Isometric Quadriceps Strength limb symmetry index
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 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.
Isometric Hamstring Strength Peak Torque
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op
Isometric strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isometric Hamstring Strength Limb Symmetry Index
Time frame: Change in strength at Pre-op, 3 months post-op, 6 months post-op, 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.
Isokinetic Quadriceps strength
Time frame: Change in strength at 6 months and 9 months post-op
Isokinetic strength testing to measure peak torque quadriceps strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isokinetic Quadriceps Strength limb symmetry index
Time frame: Change in strength at 6 months and 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.
Isokinetic Hamstrings Strength
Time frame: Change in strength at 6 months and 9 months post-op
Isokinetic strength testing to measure peak torque hamstring strength (unit: ft-lbs) as reported by isokinetic dynamometer on involved and uninvolved limb.
Isokinetic Hamstring Strength limb symmetry index
Time frame: Change in strength at 6 months and 9 months post-op
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.
5 secondary outcomes
Quadriceps Hypertrophy
Time frame: Change in strength at Pre-op, 8 weeks, 3months post-op, 6months, 9 months post-op
Pediatric International Knee Documentation Committee
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Knee Outcomes and Osteoarthritis Scale
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Anterior Cruciate Ligament- Return to Sport after Injury
Time frame: Tracking change at Pre-op, 3months post-op, 6 months post-op, 9 months post-op. 2 years post-op
Tegner Activity Scale
Time frame: changes from pre-operative, 9 months, and 2 years post-operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Weaver, PT, DPT principal investigator
Physical Therapist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction using Delfi Personalized Tourniquet System in people with Anterior Cruciate Ligament Injuries and Knee Injuries, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam P Weaver, PT, DPT (8602840296 ext. 79296, aweaver@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Change in range of motion at Pre-op, 3 months post-op, 6 months post-op, 9 months post-op). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.