Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 12:35 PM
Study NCT ID:
NCT06533293
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2024-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Neck Control in Children With Cerebral Palsy Using Robotics
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Promoting Functional Neck Motion in Patients With Cerebral Palsy Using a Dynamic Neck Brace
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: