An observational study in Cerebral Palsy, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by University of Washington · Observational
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.
1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's enrollment of 55 is below the median of 63 across 465 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Procedure: Single-event multilevel surgery
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.
Time frame: 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.
Time frame: 1-year after individual's orthopaedic surgery
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.
Time frame: 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.
Time frame: 1-year after individual's orthopaedic surgery
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.
| Milestone | Orthopaedic Surgery |
|---|---|
| Started | 55 |
| Completed | 46 |
| Not completed | 9 |
| Withdrew: Lost to follow-up | 9 |
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.
| normalized z-score | Orthopaedic Surgery |
|---|---|
| Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery | -2.4 ± 6.0 |
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.
| normalized z-score | Orthopaedic Surgery |
|---|---|
| Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery | -2.7 ± 6.7 |
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.
| normalized z-score | Orthopaedic Surgery |
|---|---|
| Change in Gait Deviation Index 6-months After Orthopaedic Surgery | 2.8 ± 9.2 |
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.
| normalized z-score | Orthopaedic Surgery |
|---|---|
| Change in Gait Deviation Index 1-year After Orthopaedic Surgery | 2.1 ± 8.1 |
Collected over Adverse events data were collected from baseline to the 12-month follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Orthopaedic Surgery | 0/55 (0%) | 0/55 (0%) | 0/55 (0%) |
| Age, Continuous(years) | Orthopaedic Surgery |
|---|---|
| Mean | 10.5 ± 3.1 |
| Sex: Female, Male(Participants) | Orthopaedic Surgery |
|---|---|
| Female | 19 |
| Male | 36 |
| Ethnicity (NIH/OMB)(Participants) | Orthopaedic Surgery |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 53 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Orthopaedic Surgery |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 47 |
| More than one race | 1 |
| Unknown or Not Reported | 3 |
| Gait Deviation Index (GDI)(z-score) | Orthopaedic Surgery |
|---|---|
| Mean | 68.2 ± 12.1 |
| Dynamic Motor Control (DMC)(normalized z-score) | Orthopaedic Surgery |
|---|---|
| Mean | 80.5 ± 9.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
Ran from Sep 2015 to primary completion in Sep 2020, 60 months.
Results were first posted in May 2022, 1 year 8 months after primary completion.
Of 209 non-industry observational studies under Cerebral Palsy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 59. This study's 60 months is above that.
Counting every sponsor, half of 213 studies reached it within 20 months; a quarter within 8 and three quarters within 59.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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