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Traumatic knee injury is common and highly debilitating. Surgical reconstruction/repair improves knee biomechanics and function, but neuromuscular dysfunction persist for years despite rehabilitation, hindering resumption of normal activities, increasing risk of further injury and, in a majority of patients, hastening the development of knee osteoarthritis (OA). Our goal in this research study is to evaluate the utility of neuromuscular electrical stimulation (NMES), initiated following injury and maintained through the early post-surgical period, to prevent muscle atrophy and intrinsic contractile dysfunction compared to active control intervention of micro-electrical stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NMES | Experimental | Neuromuscular electrical stimulation (NMES) group |
|
| Microstimulation | Active Comparator | Microstimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical stimulation | Device | Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional Area of Skeletal Muscle Fibers (All Fibers) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Difference between injured and non-injured leg at 3 weeks post-surgery |
| Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers) | Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis | Difference between injured and non-injured leg at 3 weeks post-surgery |
| Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers) | Maximal shortening velocity from segments of chemically-skinned single human muscle fibers will be assessed, with muscle fiber type determined post-measurement by gel electrophoresis | Difference between injured and non-injured leg at 3 weeks post-surgery |
| Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Difference between injured and non-injured leg at 3 weeks post-surgery |
| Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Difference between injured and non-injured leg at 3 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extensor Peak Isokinetic Torque | Peak isokinetic torque is measures in injured and non-injurd leg at 60 deg/s using dynamometry | Difference between injured and non-injured leg at 6 months post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Toth, Ph.D. | University of Vermont | Principal Investigator |
| Bruce D. Beynnon, Ph.D. | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vermont College of Medicine | Burlington | Vermont | 05405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32631074 | Derived | Toth MJ, Tourville TW, Voigt TB, Choquette RH, Anair BM, Falcone MJ, Failla MJ, Stevens-Lapslaey JE, Endres NK, Slauterbeck JR, Beynnon BD. Utility of Neuromuscular Electrical Stimulation to Preserve Quadriceps Muscle Fiber Size and Contractility After Anterior Cruciate Ligament Injuries and Reconstruction: A Randomized, Sham-Controlled, Blinded Trial. Am J Sports Med. 2020 Aug;48(10):2429-2437. doi: 10.1177/0363546520933622. Epub 2020 Jul 6. |
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Research data (deidentified) which documents, supports and validates research findings will be stored on the University of Vermont College of Medicine computer system and will be made available upon final acceptance for publication of the major findings from the proposed studies. This includes raw data generated from all clinical and laboratory-based assessments under a data-sharing agreement.
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Enrollment started in October 2016 and ended in December 2018. Patients were enrolled from an academic orthopedic surgical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | NMES | Neuromuscular electrical stimulation (NMES) group Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery. |
| FG001 | Microstimulation | Microstimulation Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Three (3) patients in NMES and two (2) patients in microstimulation groups were lost to follow-up for analyses of primary aim.
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| ID | Title | Description |
|---|---|---|
| BG000 | NMES | Neuromuscular electrical stimulation (NMES) group Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery. |
| BG001 | Microstimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Cross-sectional Area of Skeletal Muscle Fibers (All Fibers) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Posted | Mean | Standard Error | micrometer squared | Difference between injured and non-injured leg at 3 weeks post-surgery |
|
6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
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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 | Microstimulation | Microstimulation: Sham control group | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Re-injury of ACL (graft failure) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient re-injured ACL/tore ACL graft several weeks after completing final study assessments while engaging in sporting activity. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Toth | University of Vermont College of Medicine | 802-656-7989 | michael.toth@med.uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2019 | Nov 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2019 | Jan 1, 2021 | SAP_001.pdf |
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| Microstimulation | Device | Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery. |
|
Microstimulation Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Type of Injury | Count of Participants | Participants |
|
|
|
|
| Primary | Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers) | Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis | Difference in sample size in NMES group is due to the fact that one volunteer did not have sufficient tissue to allow assessment of muscle fiber mechanical properties. | Posted | Mean | Standard Error | mN/mm2 | Difference between injured and non-injured leg at 3 weeks post-surgery |
|
|
|
| Primary | Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers) | Maximal shortening velocity from segments of chemically-skinned single human muscle fibers will be assessed, with muscle fiber type determined post-measurement by gel electrophoresis | Difference in sample size in NMES group is due to the fact that one volunteer did not have sufficient tissue to allow assessment of muscle fiber mechanical properties. | Posted | Mean | Standard Error | muscle length per second (ML/s) | Difference between injured and non-injured leg at 3 weeks post-surgery |
|
|
|
| Primary | Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Posted | Mean | Standard Error | micrometer squared | Difference between injured and non-injured leg at 3 weeks post-surgery |
|
|
|
| Primary | Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA) | Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types | Posted | Mean | Standard Error | micrometer squared | Difference between injured and non-injured leg at 3 weeks post-surgery |
|
|
|
| Secondary | Knee Extensor Peak Isokinetic Torque | Peak isokinetic torque is measures in injured and non-injurd leg at 60 deg/s using dynamometry | Difference in number of volunteers in analysis is due to loss of patients during 6-month follow-up. | Posted | Mean | Standard Error | % (injured to non-injured leg) | Difference between injured and non-injured leg at 6 months post-surgery |
|
|
|
|
| 11 |
| 0 |
| 11 |
| 2 |
| 11 |
| EG001 | Neuromuscular Electrical Stimlulation | Neuromuscular electrical stimulation: Treatment group | 0 | 14 | 0 | 14 | 2 | 14 |
|
| Re-injury of meniscus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient re-injured damaged meniscus during 6-month post-surgery follow-up. |
|
| Muscle strain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Patient experienced muscle strain during muscle strength assessment. |
|
| Procedural complication. | Skin and subcutaneous tissue disorders | Systematic Assessment | Patient developed rash related to antiseptic used during muscle biopsy procedure. |
|
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