Recruiting

Robotics & Coordination

Sponsor:

Columbia University

Code:

NCT06533293

Conditions

Cerebral Palsy

Neck Disorder

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Accepted

Interventions

Neck Brace Device

Study Details

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

Study ID

NCT06533293

Start date

Mar 6, 2025

Status verified date

Sep, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Device

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

Interventions

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Sunil K Agrawal, PhD

2128542841sunil.agrawal@columbia.edu

Victor Santamaria

vsantama@nymc.edu

Locations

ROAR Lab, Mudd Hall

Recruiting

New York, New York, United States, 10027

Contacts

Sunil Agrawal, PhD

212-854-2841sunil.agrawal@columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • Motor training, Robotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-09.