Mobile Application for Gait Training in Parkinson's Disease

Официальное название

Development and Investigation of the Effectiveness of an External Stimulus-Supported Gait Training Mobile Application for Patients With Parkinson's Disease

Обзор

The developed mobile application provides patient-specific metronome-based auditory cues and simultaneous tactile vibrations to regulate walking rhythm. In this study, the effects of the mobile application on walking performance and balance in patients with Parkinson's disease will be examined in a single-center, controlled design. Participants will undergo gait training for 30 minutes per day, 3 days a week, for a total of 6 weeks. The experimental group will use the mobile application, while the control group will receive standard gait training without any external stimuli. Walking and functional performance will be assessed before and after the intervention using the Timed Up and Go Test (TUG) to assess functional mobility and dynamic balance, the 5-Times Sit to Stand Test (5xSST) to evaluate lower extremity functional strength, and the Freezing of Gait Questionnaire (FOGQ) to evaluate freezing episodes. Additionally, spatiotemporal walking parameters will be measured using a separate gait analysis mobile application. Appropriate statistical tests will be applied, and a significance level of p\<0.05 will be considered.

Подробное описание

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).

Вмешательства

• Устройство Mobile Application (Auditory and Tactile Stimuli)
  A smartphone application providing automated, patient-specific metronome sounds and tactile vibrations to support optimal walking speed and rhythm.

Первичные конечные точки

• Gait Speed [Срок оценки: Baseline and 6 weeks]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline and 6 weeks]
• Dual-Task Timed Up and Go Test [Срок оценки: Baseline and 6 weeks]
• Freezing of Gait Questionnaire (FOGQ) [Срок оценки: Baseline and 6 weeks]
• Falls Efficacy Scale-International (FES-I) [Срок оценки: Baseline and 6 weeks]
• Five Times Sit to Stand Test (5xSST) [Срок оценки: Baseline and 6 weeks]
• Trunk Impairment Scale (TIS) [Срок оценки: Baseline and 6 weeks]
• System Usability Scale (SUS) [Срок оценки: 6 weeks]
• Digital Competence Inventory for Older Adults [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Cadence [Срок оценки: Baseline and 6 weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Ege University — Izmir

Идентификаторы

NCT: NCT07687979 · 324S023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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