Robot-assisted Training in Children With CP

Last updated: June 4, 2024
Sponsor: Cook Children's Health Care System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Palsy

Treatment

Robot (Amadeo)-assisted Training

Clinical Study ID

NCT06450158
2021-012
1R218D090549-02
  • Ages 7-18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • An evaluation by a pediatric neurologist, Physical Medicine and Rehabilitation (PMNR) physicians (physiatrists), neonatal developmental specialist, orneonatologist with a diagnosis of CP.

  • Classified as high-functioning (I or II) at the Gross Motor Function ClassificationSystem (GMFCS)

  • Participants in the control group should have no history of neurological disorder orbrain injury

Exclusion

Exclusion Criteria:

  • Psychoactive or myorelaxant medication during study procedures

  • Genetic syndrome diagnosis

  • History of trauma or brain operation

  • Inability to sit still

  • Metal implants

  • Baclofen pump

  • Inability or unwillingness of patient or parent/legally authorized representative togive written informed consent

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Robot (Amadeo)-assisted Training
Phase:
Study Start date:
September 25, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

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