Cerebral Palsy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESingle-event multilevel surgery
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Gillette Children's Specialty Healthcare
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diplegic cerebral palsy * Mild or Moderate Impairment, Gross Motor Function Classification System (GMFCS) Levels I-III * Will receive follow-up care and physical therapy within the Gillette Children's Specialty Healthcare system
Exclusion criteria
* Botulinum toxin injections, baclofen, or other similar treatments in the 3 months prior to pre-operative gait analysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery | 6-months after individual's 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. |
| Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery | 1-year after individual's 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Deviation Index 6-months After Orthopaedic Surgery | 6-months after individual's 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. |
| Change in Gait Deviation Index 1-year After Orthopaedic Surgery | 1-year after individual's 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Orthopaedic Surgery Single-event multilevel surgery | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Orthopaedic Surgery |
|---|---|
| Age, Continuous | 10.5 years STANDARD_DEVIATION 3.1 |
| Dynamic Motor Control (DMC) | 80.5 normalized z-score STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gait Deviation Index (GDI) | 68.2 z-score STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
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.
Time frame: 1-year after individual's orthopaedic surgery
Population: 46 of the 55 participants returned for 12-month post-operative gait analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthopaedic Surgery | Change in Walk Dynamic Motor Control Index 1-year After Orthopaedic Surgery | -2.7 normalized z-score | Standard Deviation 6.7 |
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.
Time frame: 6-months after individual's orthopaedic surgery
Population: 32 of the 55 participants returned for 6-month post-operative gait analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthopaedic Surgery | Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery | -2.4 normalized z-score | Standard Deviation 6 |
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.
Time frame: 1-year after individual's orthopaedic surgery
Population: 46 of the 55 participants returned for 12-month post-operative gait analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthopaedic Surgery | Change in Gait Deviation Index 1-year After Orthopaedic Surgery | 2.1 normalized z-score | Standard Deviation 8.1 |
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.
Time frame: 6-months after individual's orthopaedic surgery
Population: 32 of the 55 participants returned for 6-month post-operative gait analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Orthopaedic Surgery | Change in Gait Deviation Index 6-months After Orthopaedic Surgery | 2.8 normalized z-score | Standard Deviation 9.2 |