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Идёт набор NCT07424924

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

— Наблюдательное Parkinson Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Parkinson Disease. Базовые параметры: 40 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Mini Balance Evaluation Systems Test (Mini-BESTest) Score [Срок оценки: Baseline (single assessment during study participation)]
Вторичные конечные точки (5)
  • Kinovea-Based Gait Parameters (Step Length and Stride Length) [Срок оценки: Baseline (single assessment during study participation)]
  • 2-Minute Walk Test (2MWT) Distance [Срок оценки: Baseline (single assessment during study participation)]
  • Daily Step Count (Wearable-Recorded Physical Activity) [Срок оценки: 7 days (during one-week monitoring period)]
  • Pittsburgh Sleep Quality Index (PSQI) Total Score [Срок оценки: Baseline (single assessment during study participation)]
  • Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time) [Срок оценки: 7 days (during one-week monitoring period)]

Критерии участия

Критерии включения

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

Критерии исключения

(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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр
  • Biruni University Hospital — Istanbul

Публикации

  • Bene R, Antic S, Budisic M, Lisak M, Trkanjec Z, Demarin V, Podobnik-Sarkanji S. Parkinson's disease. Acta Clin Croat. 2009 Sep;48(3):377-80. PMID 20055267
  • Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg Psychiatry. 2008 Apr;79(4):368-76. doi: 10.1136/jnnp.2007.131045. PMID 18344392
  • Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19. PMID 25904081

Идентификаторы

NCT: NCT07424924 · BiruniUniv.

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗