Robot-assisted Training in Children With CP

June 4, 2024 updated by: Cook Children's Health Care System

Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group I
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.
Device: Robot (Amadeo)-assisted Training

Amadeo® 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.
No Intervention: Control Group I
Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy.
Experimental: Experimental Group II
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.
Device: Robot (Amadeo)-assisted Training

Amadeo® 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.
No Intervention: Control Group II
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Density Electroencephalogram (HD-EEG)
Time Frame: Baseline, Day 15, Day 60

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.
Baseline, Day 15, Day 60
Transcranial magnetic stimulation (TMS)
Time Frame: Baseline, Day 15, Day 60
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.
Baseline, Day 15, Day 60
MRI
Time Frame: Day 15
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.
Day 15
Pegboard Test
Time Frame: Baseline, Day 15, Day 60
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.
Baseline, Day 15, Day 60
Assisting Hand Assessment (AHA)
Time Frame: Baseline, Day 15, Day 60
The AHA is an evaluation tool that measures and describes how children with an upper limb disability use his/her affected hand (assisting hand) collaboratively with the non-affected hand. The test will be performed for participants up to 12 years of age. The AHA assesses a child's spontaneous and normal way of handling objects when playing. The AHA score ranges from 22 points (hand is not used at all) to 88 points (hand is used as effectively as a normal hand).
Baseline, Day 15, Day 60
MACS assessment
Time Frame: Baseline, Day 15, Day 60
The MACS is used to measure children with CP's typical manual performance during daily activities they may encounter. The MACS describes five levels that are determined by a child's own ability to handle objects, and whether or not they need assistance to perform specific activities. The MACS levels form an ordinal scale from I (handles objects easily and successfully) to V (Does not handle objects and has severely limited ability to perform even simple actions).
Baseline, Day 15, Day 60
Two Point Discrimination
Time Frame: Baseline, Day 15, Day 60

The Touch Test® consists of two rotating, plastic disks joined together. Around the perimeter of the two disks are plastic rounded tips of the same length and diameter where all tips are paired except one. Paired tips are spaced at standard testing intervals. Participants will place their hands on a table, palms up, and close their eyes. A paired tip or single tip stimulus is applied randomly to the tip of a digit for at least three seconds, and the participant is asked to state whether he/she perceived a one-point or a two-point stimulus. Testing is conducted the same way for the dynamic test, but the stimulus is dragged from the bottom of the finger to the tip. Two-point discrimination is scored as 1 (normal), 2 (fair), and 3 (poor).

Monofilament measures touch sensitivity of the tip of all five fingers. Monofilament scores are 1 (normal), 2 (fair), and 3 (poor).
Baseline, Day 15, Day 60
Monofilament
Time Frame: Baseline, Day 15, Day 60

Touch sensitivity will be measured at the tip of all five fingers using von Frey monofilaments. The monofilaments consist of a set of plastic filaments with varying diameters. The monofilaments are aligned perpendicular to the skin and pressed down slowly until they started to bend. The monofilaments are held in place steadily for 1.5 seconds before being removed in the same way as they were applied. Participants are instructed to notify the experimenter if they felt any sensation of touch by saying ''yes" or ''no", and are asked to indicate on which finger they felt a sensation by either touching the finger or expressing it vocally.

Monofilament scores are 1 (normal), 2 (fair), and 3 (poor).
Baseline, Day 15, Day 60
Force
Time Frame: Baseline, Day 15, Day 60
This is measured by Amadeo. This assesses a person's isometric finger and grip strength. The measurement is grip strength in Newton.
Baseline, Day 15, Day 60
Range of motion
Time Frame: Baseline, Day 15, Day 60
This is measured by Amadeo. This measures the extension and flexion range of individual finger in mm.
Baseline, Day 15, Day 60
Spasticity
Time Frame: Baseline, Day 15, Day 60
This is measured by Amadeo. This assesses the existence and severity of spasticity with scores of 1 (normal), 2 (fair), and 3 (poor).
Baseline, Day 15, Day 60
Tone
Time Frame: Baseline, Day 15, Day 60
This is measured by Amadeo. This measures the tension of the finger muscles. Tone scores are measure from 0 (normal) to 4 rigid.
Baseline, Day 15, Day 60
Hand motion trajectory (aiming & pointing test)
Time Frame: Baseline, Day 15, Day 60
The Aiming & Pointing test is a computerized task, in which a participant will hold a digitizer pen and slice the digitizer on a tablet to control the movement of a cursor dot to hit a target dot (both dots displayed on a computer/laptop screen). This measures the accuracy of a child's aiming and pointing movements in mm.
Baseline, Day 15, Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Children's Health Care System

Investigators

  • Principal Investigator: Christos Papadelis, PhD, Cook Children's Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2021

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-012
  • 1R218D090549-02 (Other Grant/Funding Number: NICHD)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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