Training Upper Limbs of Neurodiverse Children by Connecting Brain Activities to a Virtual Reality Based Game

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT06818877
Status
Recruiting
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Conditions

  • CP
  • CP (Cerebral Palsy)
  • Cerebral Palsy
  • Healthy Children

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Brain-Computer Interface (BCI)-HABIT-VR — DEVICE
    Recent research indicates that running a camp using virtual reality (VR) software designed for a technique called hand-arm bimanual Intensive Training (HABIT) can help improve movement planning and execution in children with cerebral palsy (CP). In this study, investigators aim to combine brain activity monitoring (known as Brain-Computer Interface Neurofeedback, or BCI-NFT) to aid the rehabilitation of upper limb movements in children with CP. Furthermore, this new VR system (BCI-HABIT-VR) effects on brain activity and arm movement skills will be compared to the traditional HABIT-VR program.
  • Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR) — DEVICE
    Participants will engage in a virtual reality (VR) game designed to train upper limbs. A wristband, called the Empatica E4, will be worn which will help measure various factors such as heart rate, sweat levels, and skin temperature. Additionally, the upper limb movements during the game will be measured. There will be no brain activity recording for this group.

Study Details

This study is testing ways to help children with cerebral palsy (CP) improve how their hands work. Investigators want to see if brain activity using a virtual reality (VR) program can make their hands work better. The program is called Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR). Investigators will compare how well HABIT-VR works to a simple VR program. In the study a VR game will be played and participants in the treatment group, will have hand muscles gently stimulated to help the joints move.

Key Dates

First listed
Feb 11, 2025
Start date
Jul 30, 2025
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    There is no intervention for this group. Investigators will record healthy children's brain activity to train the virtual reality (VR) program to improve upper limb function.
  • Experimental: Cerebral Palsy Group
    Participants in the Cerebral Palsy Group (CP) will be split into two groups of two partici\[ants. Both groups will play some VR games while hand movements are tracked. These groups will switch after approximately 2 hours. The two groups are Condition 1 (standard HABIT in HABIT-VR camps and HABIT-VR in BCI-HABIT-VR camps) and Condition 2 (VR HABIT in HABIT-VR camps and BCI-augmented VR HABIT in BCI-HABIT-VR camps).

Primary Outcome Measure

Assisting Hand Assessment [ Time Frame: From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical Center, Munroe-Meyer InstituteOmahaNebraska68106
Dr. Andrea Cunha, PT, PhD
[email protected]
402-559-6219

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By research site
University of Nebraska Medical Center, Munroe-Meyer Institute· Omaha, NE

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