Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task

23 de junio de 2026 actualizado por: Bezmialem Vakif University

Effects of Cognitive-Based Balance Rehabilitation on Balance, Gait and Cognitive Functions in Parkinson's Disease Patients: Comparison of Virtual Reality and Dual Task

This prospective, randomized, single-blind, controlled clinical trial aims to evaluate and compare the efficacy of cognitive-based balance rehabilitation delivered via immersive Virtual Reality (VR) versus traditional Dual-Task Training (DTT) on balance, gait, cognitive functions, and quality of life in patients with Parkinson's Disease (PD). Postural instability and cognitive decline are hallmark features of progressive PD that significantly elevate fall risks and compromise daily independence, yet conventional pharmacological therapies offer limited effectiveness in restoring complex postural control. Given that motor and cognitive processes are intrinsically linked, this study addresses a critical gap in neurorehabilitation by investigating two contemporary modalities designed to challenge these systems simultaneously. A total of 34 participants diagnosed with PD (aged 40-80 years, Hoehn and Yahr stages I-III) will be randomly allocated to either the Dual-Task Group (DTG), receiving structured therapeutic exercises integrated with sequential cognitive tasks, or the Virtual Reality Group (VRG), engaging in an immersive balance program utilizing the Oculus Quest 2® headset with the FIT-XR application. Both groups will undergo an identical intervention protocol consisting of 45-minute supervised sessions, conducted twice weekly for 8 consecutive weeks during their pharmacological "on" phase. Standardized assessments will be performed by a blinded clinician at baseline and post-intervention (Week 8). The primary outcome measures will be dynamic balance and gait assessed through the Mini-Balance Evaluations Systems Test (Mini-BESTest) alongside global cognitive performance measured via the Montreal Cognitive Assessment (MoCA). Secondary outcomes will encompass objective posturographic indices using the Biodex Balance System, motor severity via the Unified Parkinson's Disease Rating Scale (UPDRS-III), freezing of gait, health-related quality of life, global perceived improvement, and potential cyber-sickness symptoms monitored through the Virtual Reality Sickness Questionnaire (VRSQ) to comprehensively determine the safety and comparative therapeutic value of these interventions.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

34

Fase

  • No aplica

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Diagnosed with Parkinson's Disease by a neurologist.
  • Hoehn & Yahr Stage I-III.
  • Aged between 40-80 years.
  • Literate and capable of performing basic mathematical calculations.
  • Montreal Cognitive Assessment≥21
  • Stable pharmacological treatment.
  • Physician's approval for exercise participation.

Exclusion Criteria:

  • Currently participating in another exercise or drug trial.
  • Presence of any additional neurological disorders.
  • Significant musculoskeletal disorders, arthritis, or cardiovascular disease.
  • Uncontrolled epilepsy or severe orthostatic hypotension.
  • Engaged in regular moderate-intensity exercise more than once a week in the last 6 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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Dual Task Group
Participants in this group will undergo a supervised, structured therapeutic exercise program specifically designed for balance and postural control, which will be integrated with concurrent, increasingly complex cognitive tasks (such as counting backward, calculation, or memory retrieval). The intervention will consist of 45-minute sessions held twice a week for 8 consecutive weeks, totaling 16 sessions. All exercises will be conducted by a physiotherapist during the patients' pharmacological 'on' phase.
Otro: Dual Task Training (DTT)
A supervised physical therapy program consisting of motor balance and postural control exercises executed simultaneously with secondary cognitive tasks. The physical component includes progressive static and dynamic balance training, functional gait training, and coordination exercises. The concurrent cognitive tasks involve backward counting, mental arithmetic, and working memory retrieval. The intervention is delivered in 45-minute sessions, twice a week for 8 weeks (16 sessions total) by a certified physiotherapist.
Comparador activo: Virtual Reality Group
Participants in this group will engage in an immersive Virtual Reality (VR) balance rehabilitation program utilizing the Oculus Quest 3® headset. They will play the clinically validated FIT-XR application, which is tailored to target upper and lower extremity coordinate functions and dynamic balance. The exercise intensity, session duration (45 minutes), and frequency (twice a week for 8 weeks, totaling 16 sessions) will be identical to the Dual Task Group. Sessions will be supervised by a physiotherapist during the patients' pharmacological 'on' phase, with full safety protocols implemented to prevent fall risks.
Otro: Virtual Reality Training (VRT)
An immersive virtual reality rehabilitation program utilizing the Oculus Quest 3® VR headset. Participants engage in motion-based exercises within the clinically validated FIT-XR software application, specifically targeting multi-directional reaching, stepping, upper and lower limb coordination, and dynamic weight shifting. The exercise intensity, session duration (45 minutes), and frequency (twice weekly for 8 weeks, 16 sessions total) are tightly matched to the Dual Task Group. All sessions are fully supervised by a physiotherapist with standard safety measures.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mini-Balance Evaluations Systems Test
Periodo de tiempo: Baseline and Week 8
A 14-item clinical rating scale specifically focused on dynamic gait and postural control across four domains: anticipatory postural adjustments, reactive postural responses, sensory orientation, and dynamic gait. Each item is scored on a scale from 0 (unable to perform) to 2 (normal performance). The total score ranges from 0 to 28, where higher scores indicate better dynamic balance and superior postural performance.
Baseline and Week 8

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Montreal Cognitive Assessment
Periodo de tiempo: Baseline and Week 8
A 30-point screening instrument designed to detect mild cognitive impairment and dementia by evaluating short-term memory, visuospatial abilities, executive function, language, attention, concentration, working memory, and orientation. The total score ranges from 0 to 30, with higher scores indicating better global cognitive function.
Baseline and Week 8
Biodex Balance System
Periodo de tiempo: Baseline and Week 8
Postural stability (anterior-posterior stability index, mediolateral stability index, general stability index), fall risk index, and limits of stability will be assessed using the Biodex Balance System. Higher scores on stability indices indicate poorer postural stability, while higher scores on limits of stability indicate better postural control.
Baseline and Week 8
Unified Parkinson's Disease Rating Scale - Part III (Motor Examination)
Periodo de tiempo: Baseline and Week 8
A comprehensive clinical rating scale used to evaluate the severity of motor symptoms in Parkinson's disease. Part III involves the objective motor examination. Each item is scored from 0 (unaffected) to 4 (most severely affected), yielding a total score ranging from 0 to 108. Higher scores indicate greater disease severity and more pronounced motor impairment.
Baseline and Week 8
Parkinson's Disease Questionnaire-39
Periodo de tiempo: Baseline and Week 8
A 39-item self-administered, disease-specific health status instrument evaluating quality of life across 8 dimensions. Each item is scored on a scale from 0 (never) to 4 (always). Individual dimension scores and the global index are standardized to range from 0 to 100. Higher scores indicate worse quality of life (more frequent difficulties), while lower scores reflect better health status.
Baseline and Week 8
Freezing of Gait Questionnaire
Periodo de tiempo: Baseline and Week 8
A 6-item self-report questionnaire designed to evaluate the severity of freezing of gait and its impact on walking performance. It includes 4 items on freezing severity and 2 items on general walking difficulty, with each item scored from 0 to 4. The total score ranges from 0 to 24, where higher scores indicate more severe freezing of gait and a greater negative impact on gait performance.
Baseline and Week 8
Global Rating of Change Scale
Periodo de tiempo: Post-intervention (Week 8)
A 5-point Likert scale used to measure participants' subjective perception of overall health change and treatment satisfaction over the course of the study. Total scores range from -2 to +2, where -2 represents "much worse", 0 represents "the same", and +2 represents "much better". Higher scores indicate greater perceived improvement and higher treatment satisfaction.
Post-intervention (Week 8)
Virtual Reality Sickness Questionnaire
Periodo de tiempo: Post-intervention (Week 8)
A 9-item self-report questionnaire assessing general oculomotor discomfort and disorientation following the virtual reality intervention. Items are scored using a 4-point Likert scale from 0 (none) to 3 (severe). The total score ranges from 0 to 27, where higher scores indicate worse and more severe cyber-sickness symptoms. This measure is evaluated only for the Virtual Reality Group.
Post-intervention (Week 8)

Colaboradores e Investigadores

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

Patrocinador

Bezmialem Vakif University

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 (Estimado)

20 de junio de 2026

Finalización primaria (Estimado)

30 de junio de 2027

Finalización del estudio (Estimado)

30 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de junio de 2026

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

23 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

  • E-35700536-108.99-176309

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. .

Suscribir