Clinical trial NCT06450158: Robot-assisted Training in Children With CP
Official title: Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Cook Children's Health Care System
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: High Density Electroencephalogram (HD-EEG)
timeFrame: Baseline, Day 15, Day 60
measure: Transcranial magnetic stimulation (TMS)
timeFrame: Baseline, Day 15, Day 60
measure: MRI
timeFrame: Day 15
measure: Pegboard Test
timeFrame: Baseline, Day 15, Day 60
measure: Assisting Hand Assessment (AHA)
timeFrame: Baseline, Day 15, Day 60
measure: MACS assessment
timeFrame: Baseline, Day 15, Day 60
measure: Two Point Discrimination
timeFrame: Baseline, Day 15, Day 60
measure: Monofilament
timeFrame: Baseline, Day 15, Day 60
measure: Force
timeFrame: Baseline, Day 15, Day 60
measure: Range of motion
timeFrame: Baseline, Day 15, Day 60
measure: Spasticity
timeFrame: Baseline, Day 15, Day 60
measure: Tone
timeFrame: Baseline, Day 15, Day 60
measure: Hand motion trajectory (aiming & pointing test)
timeFrame: Baseline, Day 15, Day 60
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
Study officials:
affiliation: Cook Children's Health Care System
name: Christos Papadelis, PhD
role: PRINCIPAL_INVESTIGATOR
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