Viewing Study NCT06450158



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06450158
Status: RECRUITING
Last Update Posted: 2024-06-10
First Post: 2024-06-04

Brief Title: Robot-assisted Training in Children With CP
Sponsor: Cook Childrens Health Care System
Organization: Cook Childrens Health Care System

Study Overview

Official Title: Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy
Status: RECRUITING
Status Verified Date: 2024-05
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: Cerebral palsy CP is the most common physical disability in early childhood causing serious motor and sensory impairments Effective interventions for the recovery of motor functions are of profound significance to children with CP their families caregivers and health professionals Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP
Detailed Description: This study is designed to test whether robot-assisted hand training with Amadeo improves manual functions and induces cerebral neural plasticity in children with CP To evaluate the efficacy of the robot-assisted hand training investigators will measure manual motor and sensory functions with behavioral tasks and assess neural activities in the sensorimotor cortical network with high-density electroencephalography HD-EEG and transcranial magnetic stimulation TMS one day before one day after and two months after the robot-assisted training The study will provide direct evidence on the effectiveness of the robot-assisted training in recovering of manual functions in children with CP It will provide detailed insights on potential experience-dependent neuraplastic changes in the brain of children with CP It has the potential to insight the development of more effective rehabilitation for children with CP and also children with other neurological disorders like pediatric stroke It may uncover factors that will be predictive of functional improvements in individual CP patient

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
1R218D090549-02 OTHER_GRANT NICHD None