PARKINSON DIS
Conditions
Keywords
Gait Training, Freezing of Gait, Mobile Application, External Cues, Rhythmic Auditory Stimulation, Tactile Stimulation, Rehabilitation, Metronome
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.
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).
Interventions
DEVICEMobile Application (Auditory and Tactile Stimuli)
A smartphone application providing automated, patient-specific metronome sounds and tactile vibrations to support optimal walking speed and rhythm.
Sponsors
Ege University
The Scientific and Technological Research Council of Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed | 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) | 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 | 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) | 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) | 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) | 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) | 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) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Cadence | 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 |
Countries
Turkey (Türkiye)
Contacts
CONTACTMehmet Özkeskin, Associate Professor
Outcome results
None listed