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NCT Number: NCT07424924

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mini Balance Evaluation Systems Test (Mini-BESTest) Score

    Time frame: Baseline (single assessment during study participation)

    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.

Secondary outcomes

  1. Kinovea-Based Gait Parameters (Step Length and Stride Length)

    Time frame: Baseline (single assessment during study participation)

    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

  2. 2-Minute Walk Test (2MWT) Distance

    Time frame: Baseline (single assessment during study participation)

    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.

  3. Daily Step Count (Wearable-Recorded Physical Activity)

    Time frame: 7 days (during one-week monitoring period)

    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.

  4. Pittsburgh Sleep Quality Index (PSQI) Total Score

    Time frame: Baseline (single assessment during study participation)

    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.

  5. Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)

    Time frame: 7 days (during one-week monitoring period)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Güzin Kaya Aytutuldu, phd

CONTACT

[email protected]

05366265884

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Official study title

The Relationship Between Balance and Gait Impairments, Physical Activity Level, and Sleep Quality in Parkinson's Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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