Mobile Application for Gait Training in Parkinson's Disease
Development and Investigation of the Effectiveness of an External Stimulus-Supported Gait Training Mobile Application for Patients With Parkinson's Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The developed mobile application is a digital tool that provides automated, patient-specific metronome sounds and corresponding tactile vibrations to support optimal walking speed and rhythm. This study aims to investigate the effects of this external stimulus-supported gait training on walking performance and functional mobility in patients with Parkinson's disease in a single-center, controlled design.
Participants will be randomized into two groups: an experimental group receiving both auditory and tactile stimuli (vibration) via the mobile application, and a control group receiving standard gait training without any external stimuli. Both groups will undergo gait training for 30 minutes per day, 3 days a week, over a period of 6 weeks. Assessments will be conducted before and after the intervention by trained clinicians under standardized conditions. Walking and balance performance will be evaluated using the Timed Up and Go Test (TUG) to assess functional mobility and dynamic balance, the Dual-Task TUG to assess cognitive-motor interaction, the 5-Times Sit to Stand Test (5xSST) to measure lower extremity functional strength, the Trunk Impairment Scale (TIS) to evaluate trunk control, and the Falls Efficacy Scale-International (FES-I) to assess fall anxiety. Additionally, spatiotemporal walking parameters, including cadence, walking speed, and step count, will be analyzed using a separate gait analysis mobile application (Gait Analyzer).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mehmet Özkeskin, Associate Professor
- Número de teléfono: +905056631833
- Correo electrónico: mehmet.ozkeskin76@gmail.com
Ubicaciones de estudio
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İzmir
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Izmir, İzmir, Turquía (Türkiye), 35350
- Reclutamiento
- Ege university
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Contacto:
- Mehmet Özkeskin, Assoc. Prof.
- Número de teléfono: 05056631833
- Correo electrónico: mehmet.ozkeskin76@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Diagnosed with idiopathic Parkinson's disease by a neurologist based on clinical and radiological findings.
Disease severity between stages 1 to 3 according to the Modified Hoehn and Yahr Scale.
Able to walk at least 10 meters independently or with an assistive device.
Being in the "ON" period of Parkinson's medication.
Ability to use technological devices such as smartphones (scoring 35 or higher on the Digital Competence Inventory for Older Adults).
Fluent in reading, understanding, and speaking Turkish.
Voluntarily participating in the study.
Exclusion Criteria:
Having neurological disorders other than Parkinson's disease that could affect mobility.
History of knee joint surgery or traumatic injury affecting the knee joint.
History of any surgery within the last 6 months.
Presence of a deep brain stimulator.
Hearing impairment.
Cognitive impairment or inability to understand and follow the study procedures.
Other physical or systemic conditions that could affect walking assessments (e.g., amputation, severe diabetes mellitus, alcohol addiction).
Plan de estudios
¿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: Mobile Application Group
Participants will receive gait training with personalized metronome sounds (auditory stimulus) and simultaneous vibrations (tactile stimulus) using a smartphone.
The training is applied for 30 minutes per session, 3 days a week, for 6 weeks.
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A smartphone application providing automated, patient-specific metronome sounds and tactile vibrations to support optimal walking speed and rhythm.
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Sin intervención: Control Group
Participants will receive standard gait training for 30 minutes per session, 3 days a week, for 6 weeks, without any external auditory or tactile stimuli.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Gait Speed
Periodo de tiempo: Baseline and 6 weeks
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Description: Assessed objectively using the Texas Instruments SensorTag wearable sensor. Participants walk over a level surface at their self-selected speed. The device captures the gait patterns, and the system records the mean gait speed. A higher value indicates better functional mobility and improvements following the dual-task training. Unit of Measure: centimeters/second (cm/s) |
Baseline and 6 weeks
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Timed Up and Go Test (TUG)
Periodo de tiempo: Baseline and 6 weeks
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Evaluates functional mobility and dynamic balance.
The time taken to stand up from a chair, walk 3 meters, turn, walk back, and sit down is recorded in seconds.
A shorter time indicates better functional mobility.
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Baseline and 6 weeks
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Dual-Task Timed Up and Go Test
Periodo de tiempo: Baseline and 6 weeks
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Evaluates the effect of a cognitive dual-task on mobility.
Participants perform the standard TUG test while completing a simultaneous cognitive task (e.g., counting backward).
The time is recorded in seconds.
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Baseline and 6 weeks
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Freezing of Gait Questionnaire (FOGQ)
Periodo de tiempo: Baseline and 6 weeks
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Evaluates freezing episodes and gait-related experiences.
It consists of 6 items evaluated on a 5-point Likert scale.
The total score ranges from 0 to 24.
Higher scores indicate more severe freezing of gait.
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Baseline and 6 weeks
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Falls Efficacy Scale-International (FES-I)
Periodo de tiempo: Baseline and 6 weeks
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Assesses the fear of falling during physical and social activities.
It consists of 16 items on a 4-point scale.
The total score ranges from 16 to 64.
Higher scores indicate a greater fear of falling.
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Baseline and 6 weeks
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Five Times Sit to Stand Test (5xSST)
Periodo de tiempo: Baseline and 6 weeks
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Evaluates lower extremity functional strength.
The time taken to stand up and sit down five times as quickly as possible is recorded in seconds.
A shorter duration indicates better lower extremity strength.
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Baseline and 6 weeks
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Trunk Impairment Scale (TIS)
Periodo de tiempo: Baseline and 6 weeks
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Evaluates trunk control, including static sitting balance, dynamic sitting balance, and trunk coordination.
The total score ranges from 0 to 23.
Higher scores indicate better trunk performance.
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Baseline and 6 weeks
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System Usability Scale (SUS)
Periodo de tiempo: 6 weeks
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Evaluates the usability and user experience of the developed mobile application (assessed only in the experimental group).
It consists of 10 items on a 5-point Likert scale.
Higher scores indicate better usability.
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6 weeks
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Digital Competence Inventory for Older Adults
Periodo de tiempo: Baseline
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Evaluates the digital competence of participants in using technological devices.
It consists of 24 items across four subscales: information literacy, communication and collaboration, safety, and problem-solving.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cadence
Periodo de tiempo: Baseline and 6 weeks
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Description: Evaluated using the Texas Instruments SensorTag wearable sensor during walking at a self-selected speed. The system records the step rate. A higher value generally indicates a more efficient walking pattern. Unit of Measure: steps/second |
Baseline and 6 weeks
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Colaboradores e Investigadores
Patrocinador
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
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Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 324S023
Información sobre medicamentos y dispositivos, documentos del estudio
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