Robot-assisted Training in Children With CP

NCT06450158 | Recruiting FDA Device

• 2 other identifiers: 2021-0121R218D090549-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (13)

• 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.

  Baseline, Day 15, Day 60

• 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.

  Baseline, Day 15, Day 60

• 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.

  Day 15

• 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.

  Baseline, Day 15, Day 60

• Assisting Hand Assessment (AHA)

  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

  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

  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

  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

  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

  This is measured by Amadeo. This measures the extension and flexion range of individual finger in mm.

  Baseline, Day 15, Day 60

• Spasticity

  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

  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)

  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

Study Arms (4)

Experimental Group I

EXPERIMENTAL

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

Control Group I

NO INTERVENTION

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

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

Control Group II

NO INTERVENTION

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.

Interventions

Robot (Amadeo)-assisted Training DEVICE

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.

Experimental Group I; Experimental Group II

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook Children's Health Care System: lead

Study Sites (1)

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

RECRUITING

Related Publications (30)

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MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Christos Papadelis, PhD

  Cook Children's Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie J Bailey, PhD

CONTACT

682-885-2488; laurie.bailey@cookchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: September 25, 2021
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-05

Locations

US (1)