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NCT06533293NARecruitingAccepts Healthy Volunteers

Improving Neck Control in Children With Cerebral Palsy Using Robotics

Columbia University

Start Date

3/6/2025

Completion Date

12/30/2026

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.

Detailed Description

The study investigators plan to recruit a sample of 30 children and adults (10 able-bodied children/young adults for the characterization phase and 20 children/young adults with bilateral cerebral palsy: 10 classified as GMFCS IV and 10 classified as GMFCS V). These participants will be aged 11-21 years. 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.

Eligibility Criteria

Age Range: 11 years to 21 years

Inclusion Criteria: * CP, as medical diagnosis * GMFCS IV-V classification Exclusion Criteria: * 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

Interventions

DEVICE

Neck Brace Device

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Conditions

Cerebral PalsyNeck Disorder

Locations

ROAR Lab, Mudd Hall

New York, New York 10027

United States

Columbia University Irving Medical Center

New York, New York 10032

United States