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

NCT06818877 | Recruiting FDA Device

• 3 other identifiers: 0407-24-FB1R15HD117277-01P20GM109090
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Children; CP (Cerebral Palsy); CP; Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• Assisting Hand Assessment

  The Assisting Hand Assessment (AHA) is scored from 0 to 100 AHA-units, with higher scores indicating greater ability in using the affected in bi-manual tasks.

  From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment

• Brain Cortical Activity Measurement by Waveguard Electroencephalogram Cap

  Changes in a participant's brain cortical activity will be measured during the intervention using a an FDA-cleared WAVEGUARD (TM) EEG Cap and an eego amplifier.

  Baseline (first assessment session) to 2 weeks

Secondary Outcomes (1)

• Box and Block Test Time

  From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.

Study Arms (2)

Control Group

NO INTERVENTION

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.

Cerebral Palsy Group

EXPERIMENTAL

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).

Device: Brain-Computer Interface (BCI)-HABIT-VR; Device: Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR)

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.

Also known as: BCI-HABIT-VR Group

Cerebral Palsy Group

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.

Also known as: HABIT-VR Group

Cerebral Palsy Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with cerebral palsy
• Aged 6 to 17
• Unilateral and bilateral cerebral palsy (Hemiplegic or Diplegic cerebral palsy)
• Manual Ability Classification System Score (MACS) between I-IV.
• Gross Motor Function Classification System (GMFCS) levels ranging from I to III.
• Ability to follow verbal instructions
• Typically developing children
• Aged 6 to 17
• Good physical health
• Ability to follow verbal instructions

You may not qualify if:

• Children with cerebral palsy
• Other conditions leading to the inability to move the upper extremity or handle objects
• Visual impairments preventing the performance of intervention and testing tasks
• Received an intensive therapeutic intervention involving upper extremities, botulinum toxin in an upper extremity within the past 6 months, or any upper extremity surgery in the past year
• Typically developing children
• Chronic illnesses or medical conditions that could impact their development
• Significant behavioral or emotional issues that could indicate developmental disorders or psychological conditions
• Diagnosed developmental disorders \[e.g., autism, Attention-deficit/hyperactivity disorder (ADHD), learning disabilities\]

Sponsors & Collaborators

• University of Nebraska: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Nebraska Medical Center, Munroe-Meyer Institute

Omaha, Nebraska, 68106, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Ahad Behboodi, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahad Behboodi, PhD

CONTACT

402-554-7525; abehboodi@unomaha.edu

Study Design

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

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 11, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)