Mobile Application for Gait Training in Parkinson's Disease

NCT07687979 | Recruiting

• 1 other identifier: 324S023
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

PARKINSON DIS

Keywords

Gait Training; Freezing of Gait; Mobile Application; External Cues; Rhythmic Auditory Stimulation; Tactile Stimulation; Rehabilitation; Metronome

Outcome Measures

Primary Outcomes (9)

• 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)

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

Secondary Outcomes (1)

• Cadence

  Baseline and 6 weeks

Study Arms (2)

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.

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.

Interventions

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.

Mobile Application Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ege University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ege University

Izmir, İzmir, 35350, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Mehmet Özkeskin, Associate Professor

CONTACT

+905056631833; mehmet.ozkeskin76@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 7, 2026
• Study Start: April 7, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-04

Locations

TU (1)