Improving Neck Control in Children With Cerebral Palsy Using Robotics

September 8, 2025 updated by: Sunil Agrawal, Columbia University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Irving Medical Center
        • Contact:
      • New York, New York, United States, 10027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device
Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.
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.
Data will be collected at baseline, immediately after post-intervention, 1 week post-intervention, and 3 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

New York Medical College

Investigators

  • Principal Investigator: Sunil Agrawal, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

June 8, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAV1209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a exploratory study at this point.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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