- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07664878
AR-Based Motor Rehabilitation for Children With CP (PSYCHO-AR-REH)
25 de junio de 2026 actualizado por: Rudolf Psotta, College of Physical Education and Sport PALESTRA
Digitalization of Rehabilitation Care for Children With Motor Disorders Using Augmented Reality Technologies
The aim of the project is to create a digital system for cognitive-oriented rehabilitation of the central neuromuscular diseases (CND) with the use of augmented reality (AR) technology in children.
Solving the project supports the professional-oriented digital literacy of professionals in rehabilitation institutions in the Czech Republic (CR).
With the applied research, the software will be developed for the training of fine and gross motor skills, postural control and walking in the AR environment for children with cerebral palsy and verified in the practice of professionals in rehabilitation.
The project aims to modernization and increase of the effectiveness of the work of professionals in rehabilitation institutions in the CR.
The project is based on an interdisciplinary approach.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
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.
Ubicaciones de estudio
-
-
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Prague, Chequia
- Palestra
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-
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
No
Descripción
Inclusion Criteria:
- Medical diagnosis of spastic hemiparesis or diparesis types cerebral palsy
- The level of motor skills was at levels I and II according to the Gross Motor Function Classification System (GMFCS)
- spasticity of grade 2 or less diagnosed with the Modified Ashworth Scale (MAS)
- Ability to walk at least 10 meters without aids and without the support of a therapist
Exclusion Criteria:
- no neurological disease other than CP
- no visual impairment with exception of short-sightedness
- Children is not able to follow instructions during testing and training
- Injection treatment of anti-spastic medication in the last 3 months
- Lower limb surgery within the past 12 months
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: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Grupo experimental
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Traditional spa treatment comprising hydrotherapy and physical therapy.
The child wore Meta Quest 3 (Meta Platforms, Menlo Park, California, USA) VR/AR goggles during the exercises.
Our custom exercise applications were running on the device.
They provide brief verbal instructions at the start of each exercise.
During the exercise, they also give short cognitive prompts to support focused attention.
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Comparador activo: Control group
conventional physical therapy program
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Traditional spa treatment comprising hydrotherapy and physical therapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Speed of 10-meter walk test (m/s)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
Speed (m/s): average speed of the walk 10 metres (10MWT)
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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|
Cadence (steps/min)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Number of half-steps in one minute.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering)
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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|
Support phase (% cycle)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The average value of the durations of the right and left support phases as percentages of the duration of the gait cycle.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Swing Phase (% Cycle)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The average value of the durations of the right and left swing phases as percentages of the duration of the gait cycle.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
|
Symmetry index of pelvic tilt
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the sagittal component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Symmetry index of pelvic obliquity
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the frontal component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
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Symmetry index of pelvic rotation
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle.
Non-pathological subjects show an index greater than 90.
The pelvic tilt, is the transverse component of 3D pelvic movement.
Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).
|
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
|
The Pediatric balance scale (PBS)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
The Pediatric Balance Scale is a modified version of the Berg Balance Scale.
The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Higher total scores suggest that the child has good balance ability.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
One-Leg Balance (valuated by the time the child is able to maintain the position)
Periodo de tiempo: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
In this task, the child is asked to stand on one leg on a balance board or other unstable surface.
Each leg is tested separately.
The child must maintain balance for a maximum of 30 seconds.
The task is assessed in accordance with the MABC-2 manual.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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)
1 de marzo de 2025
Finalización primaria (Estimado)
1 de agosto de 2026
Finalización del estudio (Estimado)
1 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
24 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
25 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TQ01000031
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.
No
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. .