Robot-assisted Training in Children With CP

Cook Children's Health Care System

Status: Enrolling

Conditions: Cerebral Palsy

Treatments: Device: Robot (Amadeo)-assisted Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06450158

1R218D090549-02 (Other Grant/Funding Number)

2021-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Experimental Group I

Experimental group

Description:

Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy. Amadeo will be used to train the more-affected hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.

Treatment:

Device: Robot (Amadeo)-assisted Training

Control Group I

No Intervention group

Description:

Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy.

Experimental Group II

Experimental group

Description:

Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury. Amadeo will be used to train the non-dominant hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.

Treatment:

Device: Robot (Amadeo)-assisted Training

Control Group II

No Intervention group

Description:

Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury.