RecruitingNot ApplicableNCT06533293

Improving Neck Control in Children With Cerebral Palsy Using Robotics

Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace

Sponsor

Columbia University

Enrollment

30 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Cerebral Palsy Neck Disorder

Summary

The goal of this study is to characterize the head-neck motion of children with cerebral palsy and investigate how robotics can be used to improve the head-neck coordination of these children. 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.

Eligibility

Min Age: 11 YearsMax Age: 21 Years

Inclusion Criteria2

CP, as medical diagnosis
GMFCS IV-V classification

Exclusion Criteria7

severe cognitive deficits
uncontrolled epilepsy
severe dyskinesia
spinal cord malformations
severe vertebral column deformities (scoliosis >40° and/or kyphosis >45º)
blindness
chemo-denervation 3 months before study

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Interventions

DEVICENeck 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.