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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS091056-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Gillette Children's Specialty Healthcare | OTHER |
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Impaired neuromuscular control hinders movement for individuals with cerebral palsy and other neurological disorders. In this research, the investigators are developing new tools to quantify impaired neuromuscular control in cerebral palsy and evaluate changes after one of the most common treatments, orthopaedic surgery. The results from this research will empower clinicians to identify patient-specific factors that contribute to impaired movement and improve treatment and quality of life.
The long-term goals of this research are to quantify patient-specific changes in neuromuscular control in order to optimize treatment planning and improve mobility for individuals with cerebral palsy (CP). As a first step, the aims of this proposal are to evaluate neuromuscular control before and after one of the most common treatments for individuals with CP, orthopaedic surgery. The investigators will evaluate if patient-specific measures of neuromuscular control, based upon the framework of muscle synergies, can predict improvements in walking ability after surgery. Further, investigators will determine whether neuromuscular control changes after surgery and if these changes contribute to improvements in movement. To achieve these goal the investigators will implement and test new tools to quantify neuromuscular control which integrate clinical gait analysis and two computational techniques: synergy analysis and dynamic musculoskeletal simulation. This research will provide the foundation to use measures of altered neuromuscular control to inform treatment planning, develop alternative treatments, and improve mobility in CP and other neurologic disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthopaedic surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-event multilevel surgery | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery | The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals. | 6-months after individual's orthopaedic surgery |
| Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery | The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals. | 1-year after individual's orthopaedic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gait Deviation Index 6-months After Orthopaedic Surgery | The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait. |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals with cerebral palsy, diplegia subtype, with mild or moderate impairment, Gross Motor Function Classification System (GMFCS) Levels I-III, between the ages of 6 - 18.
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| Name | Affiliation | Role |
|---|---|---|
| Katherine M Steele, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | United States |
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539 children with bilateral cerebral palsy eligible for orthopedic surgery were screened. 122 were invited to participate in the study, 45 did not meet the study criteria, 22 did not respond, and 55 participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Orthopaedic Surgery | Single-event multilevel surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Orthopaedic Surgery | Single-event multilevel surgery |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery | The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals. | 32 of the 55 participants returned for 6-month post-operative gait analysis | Posted | Mean | Standard Deviation | normalized z-score | 6-months after individual's orthopaedic surgery |
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Adverse events data were collected from baseline to the 12-month follow-up visit.
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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 | Orthopaedic Surgery | Single-event multilevel surgery | 0 |
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This was a prospective observational cohort study, not a randomized controlled trial. 32 of the 55 participants returned for the 6-month post-operative gait analysis and 46 of the 55 participants returned for the 12-month post-operative gait analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Steele | University of Washington | 206-685-2390 | kmsteele@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 15, 2022 | Mar 15, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6-months after individual's orthopaedic surgery |
| Change in Gait Deviation Index 1-year After Orthopaedic Surgery | The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait. | 1-year after individual's orthopaedic surgery |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Gait Deviation Index (GDI) | normalized z-score such that 100(10) = AVE(SD) of nondisabled peers | Mean | Standard Deviation | z-score |
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| Dynamic Motor Control (DMC) | Mean | Standard Deviation | normalized z-score |
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| Primary | Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery | The Walk Dynamic Motor Control Index (Walk DMC) is a specific measurement calculated from electromyography during gait using nonnegative matrix factorization. A value of 100 indicates complexity of neuromuscular control similar to typically-developing peers and each 10 point deviation represents one standard deviation from typically-developing peers. Thus, a value of 80 would indicate that an individual's muscle coordination during gait is two standard deviations below the complexity of unimpaired individuals. | 46 of the 55 participants returned for 12-month post-operative gait analysis | Posted | Mean | Standard Deviation | normalized z-score | 1-year after individual's orthopaedic surgery |
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| Secondary | Change in Gait Deviation Index 6-months After Orthopaedic Surgery | The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait. | 32 of the 55 participants returned for 6-month post-operative gait analysis | Posted | Mean | Standard Deviation | normalized z-score | 6-months after individual's orthopaedic surgery |
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| Secondary | Change in Gait Deviation Index 1-year After Orthopaedic Surgery | The Gait Deviation Index is a specific measurement which uses kinematics measured from instrumented gait analysis to compare an individual's gait pattern to typically-developing controls. A value of 100 indicates kinematics similar to unimpaired individuals while each 10 point deviation represents one standard deviation from unimpaired gait. Thus, a value of 80 would indicate that an individual's gait kinematics are on average two standard deviations from unimpaired gait. | 46 of the 55 participants returned for 12-month post-operative gait analysis | Posted | Mean | Standard Deviation | normalized z-score | 1-year after individual's orthopaedic surgery |
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| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
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