NCT06818877 · University of Nebraska
Training Upper Limbs of Neurodiverse Children by Connecting Brain Activities to a Virtual Reality Based Game
What this study is about
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.
View original scientific description
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.
Interventions
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.
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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 \[e.g., autism, Attention-deficit/hyperactivity disorder (ADHD), learning disabilities\]
Where
- Omaha, Nebraska
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 28, 2026 · Source of record for eligibility and locations