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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?
The planned pilot study is a prospective case control study utilizing retrospective controls. 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. The investigators are unsure of the ability for us to collect prospective controls in a timely manner, hence the investigators will use the above described retrospective cohort as controls if the prospective controls prove difficult to recruit.
Identification and Recruitment:
All potential patients undergoing ACL reconstruction at Elite Sports Medicine will be approached for participation for this study. Eligible patients will be identified at their initial pre-operative appointment with the Sports Medicine Physician, Athletic Trainer, and Sports Physical Therapy Physical Therapist. Subject selection will be completed by those patients meeting the above outlined inclusion and exclusion criteria. At this time, the study purpose and protocol will be explained and a brief summary of the study will be provided.
Consent: Consent will take place at the pre-operative visit. The patient/parent will be given a detailed description of the purpose and methodology for this study. The participants will have the opportunity to read the consent forms and ask any questions they may have about the research. If the patients agree to participate, they will be asked to sign the consent form and a copy will be provided.
Retention: Eligible patients will be required to be seen for a minimum of 90% of patient visits to be included in this study.
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. To determine the appropriate resistance for each exercise, the patient's 1 repetition maximum (1RM) will be attained using a repetition test [19]. This test will use a previously validated algorithm to determine the 1RM based on the weight used to perform a 7-10 repetition test [20]. Patient will perform the exercise with a weight they can comfortably lift for several repetitions. Based on the weight or resistance used, and the patient's perceived exertion a 1RM will be estimated using the modified OMNI-RES (OMNI perceived exertion scale for resistance). The starting load for each exercise will be 20-30% of their 1RM , or bodyweight resistance will be used when loading is not feasible.
Proposed Protocol Phase 1- Weeks 1 to 2
Quad Set: 10 second on, 10 second rest at 100% occlusion x10'
o progress to isometrics at the edge of the table 60 degrees as clinically appropriate
Side Lying Hip Abduction, 30/15/15/15, at 80% occlusion
Hip Extension from prone 30/15/15/15, at 80% occlusion
Re-check load at the start of each Phase, to determine 1 RM (7-10 RM (repetition maximum) test on leg press)
Total BFR time approximately 24 minutes per session, with 2 sessions per week
Phase 2- Weeks 3 to 4
Phase 3- Weeks 5 to 6
Phase 4- Weeks 7 to 8
Phase 5- Weeks 9 to 12
Phase 6- Weeks 11 to 12
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Pedi-IKDC (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). | at 3 months post-op and return to sport (between approximately 6-8 months post-op) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Weaver, PT, DPT | Physical Therapist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Children's Sports Physical Therapy | Farmington | Connecticut | 06032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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 |
| FG001 | 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. Per our IRB protocol, should we be unable to obtain prospective controls a review of prior patients from previous patients matched for age, sex and Surgical procedure to provide a retrospective cohort. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to fully analyze all consented patients in both groups. | Posted | Mean | Standard Deviation | Nm/kg | 3 month and return to sport post-operative strength (6-8 months post-op) |
|
Adverse events were collected during the study time period when patients were completing BFR training during their physical therapy session for 12 weeks.
monitoring for the following side effects: subcutaneous hemorrhage (SubQ), deep vein thrombosis (DVT), fainting, dizziness, lower extremity paresthesia, and itching
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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 |
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Covid-19 pandemic Lost to follow up, surgical exclusion led to small number of controls.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam P. Weaver, PT, DPT | Connecticut Children's | 860-284-0246 | Aweaver@connecticutchildrens.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2021 | Mar 30, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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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.
Not provided
Not provided
Not provided
Not provided
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Height | Mean | Full Range | inches |
|
| weight | Mean | Full Range | lbs |
|
| OG001 | 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. due to limitations in our prospective control, we use an aged match retrospective cohort of 16 patients for analysis. |
|
|
| Primary | 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% | We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all patients that were consented for analysis. | Posted | Mean | Standard Deviation | percent | 3 month and return to sport isometric quad strength limb symmetry |
|
|
|
| Primary | 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. | We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all data for consented subjects in both groups. | Posted | Mean | Standard Deviation | nm/kg | at 3 months post-op and return to sport (between approximately 6-8 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 (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% | We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use data for all consented patients for both groups. | Posted | Mean | Standard Deviation | percent | 3 months post op and return to sport (between approximately 6-8 months post-op) |
|
|
|
| Secondary | Pedi-IKDC (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). | We enrolled 47 patients in our study. Due to exclusion criteria, patients lost to follow up and COVID-19 pandemic we were unable to use all data for all consented patients in both groups | Posted | Mean | Standard Deviation | units on a scale | at 3 months post-op and return to sport (between approximately 6-8 months post-op) |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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| Return to sport (@ 6-8 months post-op) |
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| return to sport (between approximately 6-8 months post-op) |
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| return to sport (between approximately 6-8 months post-op) |
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| return to sport (between approximately 6-8 months post-op) |
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