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NCT Number: NCT06533293

Improving Neck Control in Children With Cerebral Palsy Using Robotics

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Neck Disorder Nervous System Diseases

Age range

11 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neck Brace Device

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.

Primary outcomes

  1. Seated Postural and Reaching Control (SP&R-co)

    Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.

    Measurement of head-trunk and reaching control of children and young adults with CP while sitting static, active, proactive, and reactive postural dimensions while providing support at different regions of the torso.

Secondary outcomes

  1. Gross Motor Functional Measure-items set (GMFM-IS)

    Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.

    This is an abbreviated version of the original GMFM-66 to measure the gross motor status of the children with CP across 5 dimensions: A) lying and rolling, B) Sitting, C) Crawling and Kneeling, D) Standing and E) Walking, Running and Jumping.

  2. Canadian Occupational Performance Outcome (COPM)

    Time frame: Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.

    Measurement of perceived parent- and child-based goals and preferences that are specific to motor impediments that restrict participation.

Study contacts

Contact information is provided by the study sponsor or research team.

Sunil K Agrawal, PhD

CONTACT

[email protected]

2128542841

Victor Santamaria

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • New York Medical College

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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