Improving Neck Control in Children With Cerebral Palsy Using Robotics

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06533293
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Palsy
  • Neck Disorder

Eligibility Criteria

Sex
ALL
Age
11 Years - 21 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Mar 6, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Device
    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

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Sunil Agrawal
[email protected]
212-854-2841
ROAR Lab, Mudd HallNew YorkNew York10027
Sunil Agrawal, PhD
[email protected]
212-854-2841

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By research site
Columbia University Irving Medical Center· New York, NYROAR Lab, Mudd Hall· New York, NY

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