Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy
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ClinicalTrials.gov Identifier: NCT02699554 |
Recruitment Status :
Completed
First Posted : March 4, 2016
Results First Posted : May 9, 2022
Last Update Posted : May 9, 2022
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Condition or disease | Intervention/treatment |
---|---|
Cerebral Palsy | Procedure: Single-event multilevel surgery |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 55 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 1 Year |
Official Title: | Quantifying Patient-Specific Changes in Neuromuscular Control in Cerebral Palsy |
Actual Study Start Date : | September 2015 |
Actual Primary Completion Date : | September 2020 |
Actual Study Completion Date : | September 2020 |

Group/Cohort | Intervention/treatment |
---|---|
Orthopaedic surgery |
Procedure: Single-event multilevel surgery |
- Change in Walk Dynamic Motor Control Index 6-months After Orthopaedic Surgery [ Time Frame: 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 [ Time Frame: 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.
- Change in Gait Deviation Index 6-months After Orthopaedic Surgery [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699554
United States, Minnesota | |
Gillette Children's Specialty Healthcare | |
Saint Paul, Minnesota, United States, 55101 |
Principal Investigator: | Katherine M Steele, PhD | University of Washington |
Documents provided by Katherine Steele, University of Washington:
Responsible Party: | Katherine Steele, Assistant Professor, Mechanical Engineering, University of Washington |
ClinicalTrials.gov Identifier: | NCT02699554 |
Other Study ID Numbers: |
44170 1R01NS091056-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | March 4, 2016 Key Record Dates |
Results First Posted: | May 9, 2022 |
Last Update Posted: | May 9, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cerebral Palsy Nervous System Diseases Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |