Development and Investigation of the Effectiveness of an External Stimulus-Supported Gait Training Mobile Application for Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Five Times Sit to Stand Test (5xSST)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Five Times Sit to Stand Test (5xSST)
时间窗: Baseline and 6 weeks
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.
Gait Speed
时间窗: Baseline and 6 weeks
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)
Timed Up and Go Test (TUG)
时间窗: Baseline and 6 weeks
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.
Dual-Task Timed Up and Go Test
时间窗: Baseline and 6 weeks
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.
Freezing of Gait Questionnaire (FOGQ)
时间窗: Baseline and 6 weeks
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.
Falls Efficacy Scale-International (FES-I)
时间窗: Baseline and 6 weeks
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.
Trunk Impairment Scale (TIS)
时间窗: Baseline and 6 weeks
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.
System Usability Scale (SUS)
时间窗: 6 weeks
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.
Digital Competence Inventory for Older Adults
时间窗: Baseline
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.
次要结局
- Cadence(Baseline and 6 weeks)