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[Prueba de dispositivo que no es aprobado o autorizado por la FDA de EE. UU.]

31 de agosto de 2026 actualizado por: University of Nebraska

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

51

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ahad Behboodi, PhD
  • Número de teléfono: 402-554-7525
  • Correo electrónico: abehboodi@unomaha.edu

Ubicaciones de estudio

    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68106
        • Reclutamiento
        • University of Nebraska Medical Center, Munroe-Meyer Institute
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

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]

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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).
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.
Otros nombres:
  • BCI-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.
Otros nombres:
  • HABIT-VR Group

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assisting Hand Assessment
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
Baseline (first assessment session) to 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Box and Block Test Time
Periodo de tiempo: 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.
From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Ahad Behboodi, PhD, University of Nebraska

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de julio de 2025

Finalización primaria (Estimado)

1 de mayo de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

3 de febrero de 2025

Primero enviado que cumplió con los criterios de control de calidad

7 de febrero de 2025

Publicado por primera vez (Actual)

11 de febrero de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 0407-24-FB
  • P20GM109090 (Subvención/contrato del NIH de EE. UU.)
  • 1R15HD117277-01 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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