Healthy ChildrenNCT06818877
Training Upper Limbs of Neurodiverse Children by Connecting Brain Activities to a Virtual Reality Based Game
A study testing Brain-Computer Interface (BCI)-HABIT-VR and Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR) in people with Healthy Children and CP (Cerebral Palsy), run by University of Nebraska at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children, CP (Cerebral Palsy), CP
- What is being tested?
- Brain-Computer Interface (BCI)-HABIT-VR and Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- Typically developing children
- Aged 6 to 17
- Good physical health
- Ability to follow verbal instructions
Who cannot join
- 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]
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Nebraska Medical Center, Munroe-Meyer Institute
Omaha, Nebraska, 68106
Dr. Andrea Cunha, PT, PhD, 402-559-6219, abaraldicunha@unmc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Children, CP (Cerebral Palsy), CP, Cerebral Palsy
- Being tested
- Brain-Computer Interface (BCI)-HABIT-VR, Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Computer Interface (BCI)-HABIT-VRDevice
Also called BCI-HABIT-VR Group
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
Also called HABIT-VR Group
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Brain-Computer Interface (BCI)-HABIT-VR; Device: Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (first assessment session) to 2 weeks
Secondary outcomes (1)
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.
Measured: From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start30 Jul 2025
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Sponsor
- Investigators
- Ahad Behboodi, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818877
- Sponsor's protocol ID
- 0407-24-FB
- Other IDs
- 1R15HD117277-01, P20GM109090
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No