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El ensayo clínico NCT06769178 para Parálisis cerebral está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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How Much Virtual Reality Intervention Improve the Balance of Patients with Cerebral Palsy 24 Virtual
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El ensayo clínico NCT06769178 es un estudio intervencionista para Parálisis cerebral. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de junio de 2025 hasta completar 24 participantes. Dirigido por Yeditepe University, se espera que finalice el 1 de diciembre de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 10 de enero de 2025.
Resumen
The purpose of this clinical study is to investigate how effective virtual reality applications are in adult cerebral palsy rehabilitation.
The main questions it aims to answer are:
Do virtual reality interventions (of Becure Balance and Becure Wesense Systems) improve balance and is this improvement reflected in the clinic? Is there a change in brain functional resting state networks after virtual reality interven...
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Effect of Virtual Reality-Based Interventions on Clinical and Neuroplasticity, Brain Functional Resting State Networks in Cerebral Palsy Rehabilitation
Condiciones médicas
Parálisis cerebralPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- SimayA
Número del NCT
Inicio del estudio (real)
2025-06
Última actualización
2025-01-10
Fecha de finalización (estimada)
2026-12
Inscripción (prevista)
24
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
adult cerebral palsy
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
functional magnetic reasonance imaging
virtual reality
becure systems
balance
resting state functional magnetic reasonance imaging
Objetivo principal
Otros
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Simple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalSerious Game Group BecureBalance and WesenseSystems will be used.Games'll be chosen to improve balance and empowerment,and game levels will be adjusted according to the condition of the participants.Balance Adventure is a game that involves transferring weight in 4 directions.At level 1,the goal is to reach the exit by collecting all the stars. At level 3,the goal is to collect stars on a moving surface and move the ball without droppi...Mostrar más | Virtual Reality based Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games. |
OtrosControl Group Participants in the control group will receive a total of 16 sessions of structured NGT-based exercise applications prepared by the researchers.For this, involving balance and strengthening'll be applied, focusing mainly on lower extremity movements. For warm-up exercises, trunk rotation, shoulder rotation, hip rotation and toe-to-toe elevation and descent'll be performed for 10 minutes.Strengthening exercises'll mos...Mostrar más | Virtual Reality based Participants will receive treatment by a specialist physiotherapist for a total of 16 sessions, 2 days a week on non-consecutive days for 8 weeks. Both groups will receive neurodevelopmental treatment (NGT) for 16 sessions. While the control group will receive traditional balance training in each session, the VR group will play virtual reality-based games. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Muscle Strength Assessment | Muscle strength is an important component of health. Muscle weakness is seen in the presence of neurologicaldiseases and therefore muscle strength measurement is important for general health assessment. The most common equipment or methods that provide quantitative measurements of strength, such as isokinetic and portable dynamometers, have been shown to provide valid and reliable measurements. The muscle strengths of the participants in the lower extremity (hip flexor, extensor, abductor and adductor, knee flexor and extensor, ankle dorsi-plantar flexor) muscle groups will be measured with a handheld dynamometer. | up to 8 weeks |
Timed Up and Go Test (TUG) | TUG is a rapid test used in clinic as an outcome measure to assess functional mobility as well as static and dynamic balance. It's based on the length of time which takes for an individual to get up from a chair, walk 3 meters at a comfortable (or fastest) pace, turn (or touch the wall), walk to chair and sit down again. | up to 8 weeks |
Berg Balance Scale (BBS) | The BBS, developed by Berg et al (1995) and used in the assessment of balance, is a four-point scale that rates patients' balance from easy to difficult (0: cannot do, 4: does independently). During the test consisting of 14 items, steps, rulers, stopwatches and chairs are used. The test evaluates postural control and fall risk. The maximum total score is 56 points. 0-20: high fall risk, 21-40: moderate fall risk, 41-56: low fall risk. The Turkish validity and reliability of the scale was made by Şahin et al (2008). | up to 8 weeks |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
fMRI scan | High-resolution (1 x 1 x 1 mm isotropic) sagittal 190 slices will be acquired with a T1-weighted imaging sequence (TR/TE: 7.7/3.7 ms;, FA: 8°; FOV: 256 x 256). Functional resting state data will be acquired with a single-shot echo planar imaging (EPI) sequence of 300 dynamic acquisitions consisting of 35 slices of 4 mm thickness (TR/TE: 2230/30 ms, FA: 77°; matrix: 80x80) and will last approximately 11 minutes. Magnetic field maps will be recorded in order to correct signal distortions caused by tissue inhomogeneities in the magnetic field during the analysis phase before functional acquisition. Participants will be asked to fix their gaze on a point by keeping their eyes open during functional acquisitions. Participants will be informed that they can close their eyes and rest during the other stages of the acquisitions. fMRI acquisitions will be completed in approximately 30 minutes, including the preparation stages. The MRI acquisition sequences will be as follows: Survey, Resting S | up to 8 weeks |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Todos
Being diagnosed with unilateral spastic type cerebral palsy (hemiplegic type) / Being between the ages of 18-30 / Being able to walk independently (GMFCS I-II) / Not having Botox application in the last six months / Not using any medication that will affect the study process
Having a history of epileptic attacks / Having >2 spasticity in any joint according to the modified Ashworth scale / Having severe depression according to the Beck Depression Inventory /Having hearing-vision problems
Yeditepe UniversityContactos centrales del estudio
Contacto: Simay Atıcı, PhD C, +902165780000, [email protected]
Sitio no especificado.