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

Enhancing Upper Extremity Rehabilitation in Neurodiverse Children: Brain-Computer Interface Mediated Neurofeedback and Virtual Reality for Improved Engagement and Training Quality

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Healthy Children; CP (Cerebral Palsy); CP
• Intervention / Treatment: Device: Brain-Computer Interface (BCI)-HABIT-VR; Device: Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR)

Detailed Description

Dysfunction in sensory, perceptual, and motor systems can lead to movement impairment, resulting in limitations in functional activities for children with cerebral palsy (CP). These limitations may be due to deficits in motor planning and execution. Previous investigations suggest that running a camp that uses VR software based on hand-arm bimanual Intensive Training (HABIT) improves motor planning and execution deficits in children with CP. The purpose of this study is to 1) develop a VR-augmented BrainComputer Interface Neurofeedback (BCI-NFT) for upper extremity motor rehabilitation of children with CP that can reliably deliver cortically linked neurofeedback to their forearm muscles and 2) compare the impact of BCI HABIT-VR and HABIT-VR on cortical activity and upper limb function in children with CP. Children who are 6-17 years old will be eligible for this study. Before starting the study, upper extremity motor function will be assessed with a set of clinical tests. Children with motor planning and execution deficits will receive 40 hours of either HABIT-VR or standard BCI-HABIT-VR (4 hours per day, 5 days/week, for two consecutive weeks), during which performance of the tasks and their movements will be tracked through 3-D motion tracking of the VR system. Two assessment sessions, before and after each camp, will be conducted to examine the outcome. The functional outcomes include Assistive Hand Assessment (AHA) to measure upper limb function, Box and Block Tests (BBT) to measure upper limb dexterity, and EEG recordings to measure changes in the cortical activity.

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahad Behboodi, PhD; Phone Number: 402-554-7525; Email: abehboodi@unomaha.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Recruiting
      • University of Nebraska Medical Center, Munroe-Meyer Institute
      • Contact: Dr. Andrea Cunha, PT, PhD; Phone Number: 402-559-6219; Email: abaraldicunha@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• 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

Exclusion Criteria

• 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]

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Device: Brain-Computer Interface (BCI)-HABIT-VR; 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.; Other Names: BCI-HABIT-VR Group; Device: Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR); 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.; Other Names: HABIT-VR Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test Time	The Box and Block Test Time (BBT) will count the number of aparticipant can transfer from one compartment of a divided box to the other within 60 seconds. More blocks indicates better hand function.	From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Ahad Behboodi, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): September 3, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Equipment and Supplies; Electrical Equipment and Supplies; Brain-Computer Interfaces
• Other Study ID Numbers: 0407-24-FB; P20GM109090 (U.S. NIH Grant/Contract); 1R15HD117277-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes