Improving Neck Control in Children With Cerebral Palsy Using Robotics
NCT ID: NCT06533293
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-06
2026-12-30
Brief Summary
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Aim 1 is a cross-sectional study. In this single-session, kinematic and muscle activity data will be collected during the postural static, active-proactive, and reactive postural head tasks. Gross Motor Functional Classification System (GMFCS) levels will also be collected to categorize the sample into subgroups.
Aim 2 is a prospective cohort quasi-experimental study. The data will be collected at baseline, across 12 intervention sessions, 1 week post-intervention, and 3 months follow-up.
Functional assessments will be used to compare across the pre, mid, and post training. Participants will be assessed in Gross Motor Functional Measures (GMFM), Seated Posture and Reaching Control (SP\&R-co), and Canadian Occupational and Performance Measure (COPM). The primary outcomes will be SP\&R-co test and COPM pre- and post-intervention.
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Detailed Description
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A motion capture/body mounted sensors and Electromyography (EMG) system will be used for measurement. This study will utilize specialized robotics that can apply gentle forces on the head-neck during movement training using the principles of motor learning.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
Neck Brace Device
The neck brace device will be manufactured in the Mechanical Department at Columbia University. The device measures head motion and EMG by electronic sensors, passively supports the head in certain configurations by springs, and actively assists head movement by motors.
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
Interventions
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Neck Brace Device
The neck brace device will be manufactured in the Mechanical Department at Columbia University. The device measures head motion and EMG by electronic sensors, passively supports the head in certain configurations by springs, and actively assists head movement by motors.
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
Eligibility Criteria
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Inclusion Criteria
* GMFCS IV-V classification
Exclusion Criteria
* uncontrolled epilepsy
* severe dyskinesia
* spinal cord malformations
* severe vertebral column deformities (scoliosis \>40° and/or kyphosis \>45º)
* blindness
* chemo-denervation 3 months before study
11 Years
21 Years
ALL
Yes
Sponsors
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New York Medical College
OTHER
Columbia University
OTHER
Responsible Party
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Sunil Agrawal
Professor
Principal Investigators
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Sunil Agrawal
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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ROAR Lab, Mudd Hall
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Amyotrophic lateral sclerosis patients regain head-neck control using a powered neck exoskeleton
Other Identifiers
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AAAV1209
Identifier Type: -
Identifier Source: org_study_id
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