Training Upper Limbs of Neurodiverse Children by Connecting Brain Activities to a Virtual Reality Based Game
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity of Nebraska
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Brain-Computer Interface (BCI)-HABIT-VR
DeviceRecent 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)
DeviceParticipants 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.
Treatment groups
51 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Cerebral Palsy GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment2
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.
Time frame
Baseline (first assessment session) to 2 weeksSecondary 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.
Time frame
From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nebraska
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of General Medical Sciences (NIGMS)
Collaborator
Source ClinicalTrials.gov