Recruiting

Robot-assisted Training

Sponsor:

Cook Children's Health Care System

Code:

NCT06450158

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

Interventions

Robot (Amadeo)-assisted Training

Study Details

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

Study ID

NCT06450158

Start date

Sep 25, 2021

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Primary outcome measure

  • High Density Electroencephalogram (HD-EEG) [ Time Frame: Baseline, Day 15, Day 60 ]
  • Transcranial magnetic stimulation (TMS) [ Time Frame: Baseline, Day 15, Day 60 ]
  • MRI [ Time Frame: Day 15 ]
  • Pegboard Test [ Time Frame: Baseline, Day 15, Day 60 ]
  • Assisting Hand Assessment (AHA) [ Time Frame: Baseline, Day 15, Day 60 ]
  • MACS assessment [ Time Frame: Baseline, Day 15, Day 60 ]
  • Two Point Discrimination [ Time Frame: Baseline, Day 15, Day 60 ]
  • Monofilament [ Time Frame: Baseline, Day 15, Day 60 ]
  • Force [ Time Frame: Baseline, Day 15, Day 60 ]
  • Range of motion [ Time Frame: Baseline, Day 15, Day 60 ]
  • Spasticity [ Time Frame: Baseline, Day 15, Day 60 ]
  • Tone [ Time Frame: Baseline, Day 15, Day 60 ]
  • Hand motion trajectory (aiming & pointing test) [ Time Frame: Baseline, Day 15, Day 60 ]

Central Contacts and Locations

Central contacts

Laurie J Bailey, PhD

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

Locations

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Sadra Shahdadian, PhD

(682) 885-3236Sadra.Shahdadian@cookchildrens.org

Laurie Bailey, PhD

(682) 885-2488laurie.bailey@cookchildrens.org

Principal Investigator:

Christos Papadelis, PhD

More Information

Sponsor

Cook Children's Health Care System

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cook Children's Health Care System on 2026-07-10.