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
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Mehmet Özkeskin, Associate Professor
- 電話番号：+905056631833
- メール：mehmet.ozkeskin76@gmail.com
研究場所
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İzmir
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Izmir、İzmir、トルコ（Türkiye）、35350
- 募集
- Ege university
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コンタクト：
- Mehmet Özkeskin, Assoc. Prof.
- 電話番号：05056631833
- メール：mehmet.ozkeskin76@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gait Speed
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cadence
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 324S023
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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