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Recruiting NCT06533293

Improving Neck Control in Children With Cerebral Palsy Using Robotics

No phase Interventional Cerebral Palsy Neck Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neck Brace Device.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Neck Disorder. Basic parameters: 11 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • ROAR Lab, Mudd Hall — New York
  • Columbia University Irving Medical Center — New York

Identifiers

NCT: NCT06533293 · AAAV1209

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗