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NCT Number: NCT06818877

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center, Munroe-Meyer Institute

Omaha, Nebraska, 68106, United States

Location status: Recruiting

Location contact

Dr. Andrea Cunha, PT, PhD

CONTACT

[email protected]

402-559-6219

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

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.

Other names: BCI-HABIT-VR 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.

Other names: HABIT-VR Group

Primary outcomes

  1. 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

    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.

  2. Brain Cortical Activity Measurement by Waveguard Electroencephalogram Cap

    Time frame: Baseline (first assessment session) to 2 weeks

    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.

Secondary outcomes

  1. Box and Block Test Time

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahad Behboodi, PhD

CONTACT

[email protected]

402-554-7525

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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