Robot-assisted Training in Children With CP
ConditionCerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorCook Children's Health Care System
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Psychoactive or myorelaxant medication during study procedures
Genetic syndrome diagnosis
History of trauma or brain operation
Inability to sit still
Trial design
Design model
Parallel
Treatments tested in this trial
Robot (Amadeo)-assisted Training
DeviceAmadeo® is an FDA Class I Exempt hand/finger robot that has the capacity to precisely measure hand/finger functions. To use Amadeo, a participant will be seated in a chair. The height of the robot arm support will be adjusted to achieve a comfortable position for the participant. One of the participant's arms will be will be placed on the robot arm support. Magnetic finger tips will then be attached to fingers and thumb. After this, fingers and thumb will be connected to the robot finger sliders. To use Amadeo, the movement range and maximal force of each finger will be configured according to the finger's capability. The following four types of function assessments will be performed with Amadeo: Force, range of motion, tone, and spasticity. Each session will last approximately one hour.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Experimental Group IExperimental treatment 1 intervention
Group B: Control Group INo intervention 0 interventions
Group C: Experimental Group IIExperimental treatment 1 intervention
Group D: Control Group IINo intervention 0 interventions
Trial outcomes
Primary outcomes
1
High Density Electroencephalogram (HD-EEG)
A high-density EEG net placed on participant's heads will be connected to the EEG recording device that measures the electrical potential generated by the participant's brain and recorded on the participant's scalp. After the net is placed on the head, extra leads are placed on the body for measuring electro-cardiography (ECG), electro-oculography (EOG), and electro-myography (EMG). Three tasks will be performed with simultaneous HD-EEG recording in each assessment session on the robot: one is active and passive movements of fingers with the robot; another is robotic vibration of fingers; the third is interactive game playing with the robot. The entire HD-EEG session will last up to 1.5 hours, and the participants will be given multiple breaks throughout the session. Somatosensory and motor evoked responses will be collected and quantified in the form of signal amplitude, power frequency, and localization.
Time frame
Baseline, Day 15, Day 602
Transcranial magnetic stimulation (TMS)
TMS is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain in order to map the motor cortex. During the TMS session, the participant will lay down comfortably in a specially designed armchair. The operator will initially place a band around the participant's head that is used for coregistering the participant's anatomy with respect to the location of the TMS coil.
Time frame
Baseline, Day 15, Day 603
MRI
MRI produces three-dimensional detailed anatomical image of the human brain. The imaging protocol will consist of structural MRI (T1), diffusion MRI (dMRI), and resting-state functional MRI (rs-fMRI) sequences. Scans will be performed on a 3T Siemens Tim Trio (Siemens Healthcare, USA). The entire data collection session will last \~30 min.
Time frame
Day 154
Pegboard Test
This assesses manual dexterity by measuring the time a child needs to transfer 25 cylindrical metal pegs in to 25 holes. The measurement is transfer time in seconds.
Time frame
Baseline, Day 15, Day 60Sponsors and contacts
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Source ClinicalTrials.gov