Improving Neck Control in Children With Cerebral Palsy Using Robotics

Columbia University

Status: Enrolling

Conditions: Neck Disorder; Cerebral Palsy

Treatments: Device: Neck Brace Device

Study type: Interventional

Funder types: Other

Identifiers

NCT06533293

AAAV1209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 11 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Device

Experimental group

Description:

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

Treatment:

Device: Neck Brace Device