Robot-assisted hand training for children with cerebral palsy
Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy
NA · Cook Children's Health Care System · NCT06450158
This study is testing if robot-assisted hand training can help improve hand function and brain activity in children with cerebral palsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 7 Years to 18 Years |
| Sex | All |
| Sponsor | Cook Children's Health Care System (other) |
| Locations | 1 site (Fort Worth, Texas) |
| Trial ID | NCT06450158 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of robot-assisted hand training using the Amadeo device in improving manual functions and promoting brain reorganization in children diagnosed with cerebral palsy (CP). Participants will undergo assessments of their manual motor and sensory functions before, immediately after, and two months following the training, utilizing behavioral tasks and advanced neuroimaging techniques like high-density electroencephalography (HD-EEG) and transcranial magnetic stimulation (TMS). The goal is to provide evidence on how this innovative rehabilitation approach can enhance recovery and potentially lead to predictive factors for functional improvements in CP patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with high-functioning cerebral palsy, classified as level I or II on the Gross Motor Function Classification System.
Not a fit: Patients with a history of neurological disorders, brain injuries, or those classified as low-functioning may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve motor functions in children with cerebral palsy, enhancing their quality of life.
How similar studies have performed: Other studies have shown promising results with robot-assisted rehabilitation approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * An evaluation by a pediatric neurologist, Physical Medicine and Rehabilitation (PMNR) physicians (physiatrists), neonatal developmental specialist, or neonatologist with a diagnosis of CP. * Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS) * Participants in the control group should have no history of neurological disorder or brain injury 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 to give written informed consent
Where this trial is running
Fort Worth, Texas
- Cook Children's Medical Center — Fort Worth, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Christos Papadelis, PhD — Cook Children's Health Care System
- Study coordinator: Laurie J Bailey, PhD
- Email: laurie.bailey@cookchildrens.org
- Phone: 682-885-2488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy