An observational study in Parkinson Disease, sponsored by Biruni University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Biruni University · Observational
This study aims to investigate the relationship between balance and gait impairments, physical activity levels, and sleep status in individuals with Parkinson's disease (PD). Both motor and non-motor symptoms of PD significantly affect quality of life, yet these dimensions are often evaluated separately. By examining gait, balance, physical activity, and sleep parameters together and comparing patients with healthy individuals of similar age, the study seeks to clarify how these variables interact and whether observed impairments are disease-specific or related to natural aging. The findings are expected to contribute to a more comprehensive understanding of PD and support the development of more effective management strategies.
This study will be conducted between January 2026 and May 2026 and will include 34 participants aged 45-70 years: 17 individuals diagnosed with Parkinson's disease and 17 age-matched healthy individuals without neurodegenerative disease. Participants will be recruited from Biruni University Hospital and Biruni University. Gait analysis will be performed using Kinovea software by recording a 3-meter walk in the sagittal plane, allowing evaluation of parameters such as step length and arm swing. Physical activity will be assessed using a 2-Minute Walk Test monitored with a pulse oximeter to measure oxygen saturation and functional exercise capacity, as well as daily step counts recorded over one week using a wearable smart band (Honor Choice Band). Balance will be evaluated using the Mini-BESTest. Sleep status will be assessed objectively through the smart band, which records deep sleep, light sleep, REM sleep, and wakefulness, and subjectively using the Pittsburgh Sleep Quality Index. Participants will install the Wear Sync application on their smartphones to enable synchronization and collection of wearable device data.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 34 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
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Adults aged 45-70 years will be recruited from the Department of Physical Therapy and Rehabilitation at Biruni University Hospital and from Biruni University. The study population will consist of two groups: individuals diagnosed with Parkinson's disease at Hoehn and Yahr stages 1-3 and age-matched healthy individuals without neurological or neurodegenerative disorders. All participants must be able to walk independently without assistive devices and use a smartphone for wearable device synchronization. Individuals with severe visual or hearing impairments, additional neurological disorders, significant cardiovascular or orthopedic conditions affecting gait, vascular lower extremity pathologies, or less than five years of education will be excluded
For Patients with Parkinson's Disease:
A confirmed diagnosis of Parkinson's disease according to the United Kingdom (UK) Brain Bank Criteria and classified as Hoehn and Yahr stages 1-3
Ability to walk independently on a flat surface without assistive devices (Functional Ambulation Scale ≥3)
Stable medication regimen during the past month
Being in the "on" phase of medication
For Healthy Individuals:
No diagnosis of neurological and/or neurodegenerative disease
Exclusion Criteria:
(For both Parkinson's patients and healthy individuals)
Severe hearing or visual impairments
Presence of other neurological, cardiovascular, or orthopedic conditions that may affect walking ability
Any additional neurological disorder (e.g., dementia, cerebrovascular disease)
Education level less than 5 years
Vascular pathologies affecting the lower extremities
Lack of smartphone use
Age-matched healthy individuals (45-70 years) without neurological or chronic diseases. Participants will undergo gait analysis (Kinovea), Mini-BESTest for balance assessment, 2-Minute Walk Test with pulse oximeter monitoring, one-week physical activity monitoring via wearable device (Honor Choice Band), and sleep evaluation using wearable-recorded sleep parameters and the Pittsburgh Sleep Quality Index.
Individuals aged 45-70 years diagnosed with Parkinson's disease. Participants will undergo gait analysis (Kinovea), Mini-BESTest for balance assessment, 2-Minute Walk Test with pulse oximeter monitoring, one-week physical activity monitoring via wearable device (Honor Choice Band), and sleep evaluation using wearable-recorded sleep parameters and the Pittsburgh Sleep Quality Index.
Mini Balance Evaluation Systems Test (Mini-BESTest) Score
Dynamic balance performance assessed using the Mini Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest is a 14-item clinical balance assessment tool with scores ranging from 0 to 28, where higher scores indicate better balance performance. The test evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait.
Time frame: Baseline (single assessment during study participation)
Kinovea-Based Gait Parameters (Step Length and Stride Length)
Gait performance assessed from a 3-meter walk recorded in the sagittal plane and analyzed using Kinovea software. Step length and stride length will be calculated using heel markers (right/left) placed on participants and tracked on video
Time frame: Baseline (single assessment during study participation)
2-Minute Walk Test (2MWT) Distance
Functional exercise capacity assessed using the 2-Minute Walk Test. Participants will walk for 2 minutes along a 30-meter walkway after a 30-minute rest period. Total distance walked will be recorded in meters. Heart rate and oxygen saturation will be monitored pre- and post-test using a pulse oximeter.
Time frame: Baseline (single assessment during study participation)
Daily Step Count (Wearable-Recorded Physical Activity)
Physical activity level measured as daily step count using a wearable smart band (Honor Choice Band). Participants will wear the device for 7 consecutive days during normal daily activities; step counts will be extracted via the Wear Sync application.
Time frame: 7 days (during one-week monitoring period)
Pittsburgh Sleep Quality Index (PSQI) Total Score
Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire evaluating sleep quality over the previous month. Higher total scores indicate poorer sleep quality.
Time frame: Baseline (single assessment during study participation)
Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)
Objective sleep status measured using the Honor Choice Band, including duration of deep sleep, light sleep, REM sleep, and wake time/awake episodes as recorded automatically by the device and synchronized via the Wear Sync application.
Time frame: 7 days (during one-week monitoring period)
Plan to share: No
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