Recruiting

HABIT-VR vs. VR

Sponsor:

University of Nebraska

Code:

NCT06818877

Conditions

Healthy Children

CP (Cerebral Palsy)

CP

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

Interventions

Brain-Computer Interface (BCI)-HABIT-VR

Hand and Bimanual Intensive Therapy Virtual Reality (HABIT-VR)

Study Details

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

Study ID

NCT06818877

Start date

Jul 30, 2025

Status verified date

Apr, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

51 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

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.

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 measure

  • 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 ]
  • Brain Cortical Activity Measurement by Waveguard Electroencephalogram Cap [ Time Frame: Baseline (first assessment session) to 2 weeks ]

Central Contacts and Locations

Central contacts

Ahad Behboodi, PhD

402-554-7525abehboodi@unomaha.edu

Locations

University of Nebraska Medical Center, Munroe-Meyer Institute

Recruiting

Omaha, Nebraska, United States, 68106

Contacts

Dr. Andrea Cunha, PT, PhD

402-559-6219abaraldicunha@unmc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Sep 3, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-09-03.