Gait, Physical Activity, and Sleep in Parkinson's Disease

Biruni University

Status: Enrolling

Conditions: Parkinson Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07424924

BiruniUniv.

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Trial design

34 participants in 2 patient groups

Healthy Volunteers

Description:

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.

People with Parkinson's Disease

Description:

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.