An interventional study of Mobile Application (Auditory and Tactile Stimuli) in PARKINSON DIS, sponsored by Ege University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Ege University · Not applicable, Interventional, and Treatment
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.
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).
Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.
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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).
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.
Device: Mobile Application (Auditory and Tactile Stimuli)
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.
A smartphone application providing automated, patient-specific metronome sounds and tactile vibrations to support optimal walking speed and rhythm.
Gait Speed
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)
Time frame: Baseline and 6 weeks
Timed Up and Go Test (TUG)
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.
Time frame: Baseline and 6 weeks
Dual-Task Timed Up and Go Test
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.
Time frame: Baseline and 6 weeks
Freezing of Gait Questionnaire (FOGQ)
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.
Time frame: Baseline and 6 weeks
Falls Efficacy Scale-International (FES-I)
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.
Time frame: Baseline and 6 weeks
Five Times Sit to Stand Test (5xSST)
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.
Time frame: Baseline and 6 weeks
Trunk Impairment Scale (TIS)
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.
Time frame: Baseline and 6 weeks
System Usability Scale (SUS)
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.
Time frame: 6 weeks
Digital Competence Inventory for Older Adults
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.
Time frame: Baseline
Cadence
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
Time frame: Baseline and 6 weeks
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