Robot-assisted Training in Children With CP

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Cook Children's Health Care System
Study ID
NCT06450158
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

First listed
Jun 10, 2024
Start date
Sep 25, 2021
Status verified
Jul 2026
Primary completion
Aug 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

High Density Electroencephalogram (HD-EEG) [ Time Frame: Baseline, Day 15, Day 60 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cook Children's Medical CenterFort WorthTexas76104
Sadra Shahdadian, PhD
[email protected]
(682) 885-3236
Laurie Bailey, PhD
[email protected]
(682) 885-2488
Christos Papadelis, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Cook Children's Medical Center· Fort Worth, TX

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