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NCT Number: NCT07687979

Mobile Application for Gait Training in Parkinson's Disease

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.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University

Izmir, İzmir, 35350, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Özkeskin, Assoc. Prof.

CONTACT

[email protected]

05056631833

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mobile Application (Auditory and Tactile Stimuli)

Device

A smartphone application providing automated, patient-specific metronome sounds and tactile vibrations to support optimal walking speed and rhythm.

Primary outcomes

  1. Gait Speed

    Time frame: 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)

  2. Timed Up and Go Test (TUG)

    Time frame: 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.

  3. Dual-Task Timed Up and Go Test

    Time frame: 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.

  4. Freezing of Gait Questionnaire (FOGQ)

    Time frame: 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.

  5. Falls Efficacy Scale-International (FES-I)

    Time frame: 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.

  6. Five Times Sit to Stand Test (5xSST)

    Time frame: 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.

  7. Trunk Impairment Scale (TIS)

    Time frame: 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.

  8. System Usability Scale (SUS)

    Time frame: 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.

  9. Digital Competence Inventory for Older Adults

    Time frame: 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.

Secondary outcomes

  1. Cadence

    Time frame: Baseline and 6 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Özkeskin, Associate Professor

CONTACT

[email protected]

+905056631833

Sponsors and collaborators

Lead sponsor

Ege University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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