Improving Neck Control in Children With Cerebral Palsy Using Robotics

NCT06533293 | Recruiting FDA Device

• 1 other identifier: AAAV1209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cerebral Palsy; Neck Disorder

Keywords

Motor training, Robotics

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Gross Motor Functional Measure-items set (GMFM-IS)

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

• Canadian Occupational Performance Outcome (COPM)

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

Study Arms (1)

Device

EXPERIMENTAL

Motor learning principles will be combined with robotics to apply gentle forces on the head-neck during training.

Device: Neck Brace Device

Interventions

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.

Device

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• CP, as medical diagnosis
• GMFCS IV-V classification

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• New York Medical College: collaborator

Study Sites (2)

ROAR Lab, Mudd Hall

New York, New York, 10027, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

NOT YET RECRUITING

Related Links

• Amyotrophic lateral sclerosis patients regain head-neck control using a powered neck exoskeleton

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sunil Agrawal

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunil K Agrawal, PhD

CONTACT

2128542841; sunil.agrawal@columbia.edu

Victor Santamaria

CONTACT

vsantama@nymc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an exploratory study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2024
• First Posted: August 1, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)