PARKINSON DISNCT07687979
Mobile Application for Gait Training in Parkinson's Disease
A study testing Mobile Application (Auditory and Tactile Stimuli) in people with PARKINSON DIS, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- PARKINSON DIS
- What is being tested?
- Mobile Application (Auditory and Tactile Stimuli)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Apr 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University
Izmir, İzmir, 35350
Mehmet Özkeskin, Assoc. Prof., 05056631833, mehmet.ozkeskin76@gmail.com
About this study
Official title: Development and Investigation of the Effectiveness of an External Stimulus-Supported Gait Training Mobile Application for Patients With 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.
Read the detailed description
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).
- Conditions
- PARKINSON DIS
- Being tested
- Mobile Application (Auditory and Tactile Stimuli)
- Keywords
- Gait Training, Freezing of Gait, Mobile Application, External Cues, Rhythmic Auditory Stimulation, Tactile Stimulation, Rehabilitation, Metronome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Group | Experimental | 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. Receives: Device: Mobile Application (Auditory and Tactile Stimuli) |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (1)
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
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start7 Apr 2026
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Mehmet Ozkeskin, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687979
- Sponsor's protocol ID
- 324S023
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Investigation of the Effectiveness of an External Stimulus-Supported Gait Training Mobile Application for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07687979
- Acronym / sponsor ID
- 324S023
- Conditions
- PARKINSON DIS
- Keywords
- Gait Training, Freezing of Gait, Mobile Application, External Cues, Rhythmic Auditory Stimulation, Tactile Stimulation, Rehabilitation, Metronome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Group | Experimental | Device: Mobile Application (Auditory and Tactile Stimuli)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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Mobile Application Group |
Primary outcome
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)
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Cadence
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application (Auditory and Tactile Stimuli) in people with PARKINSON DIS, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Özkeskin, Associate Professor (+905056631833, mehmet.ozkeskin76@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: Baseline and 6 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.