- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06818877
[Prueba de dispositivo que no es aprobado o autorizado por la FDA de EE. UU.]
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
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ahad Behboodi, PhD
- Número de teléfono: 402-554-7525
- Correo electrónico: abehboodi@unomaha.edu
Ubicaciones de estudio
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- Reclutamiento
- University of Nebraska Medical Center, Munroe-Meyer Institute
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Contacto:
- Dr. Andrea Cunha, PT, PhD
- Número de teléfono: 402-559-6219
- Correo electrónico: abaraldicunha@unmc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
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
¿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 |
|---|---|
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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.
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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).
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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:
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:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
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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.
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From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment
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Brain Cortical Activity Measurement by Waveguard Electroencephalogram Cap
Periodo de tiempo: Baseline (first assessment session) to 2 weeks
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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.
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Baseline (first assessment session) to 2 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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.
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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.
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From enrollment to the training sessions over two weeks and two assessment sessions within one week before and after the treatment.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ahad Behboodi, PhD, University of Nebraska
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
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)?
Información sobre medicamentos y dispositivos, documentos del estudio
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