The Relationship Between Balance and Gait Impairments, Physical Activity Level, and Sleep Quality in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Mini Balance Evaluation Systems Test (Mini-BESTest) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(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
研究组 & 干预措施
Healthy Volunteers
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
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.
结局指标
主要结局
Mini Balance Evaluation Systems Test (Mini-BESTest) Score
时间窗: 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.
次要结局
- Kinovea-Based Gait Parameters (Step Length and Stride Length)(Baseline (single assessment during study participation))
- 2-Minute Walk Test (2MWT) Distance(Baseline (single assessment during study participation))
- Daily Step Count (Wearable-Recorded Physical Activity)(7 days (during one-week monitoring period))
- Pittsburgh Sleep Quality Index (PSQI) Total Score(Baseline (single assessment during study participation))
- Wearable-Derived Sleep Parameters (Sleep Stages and Wake Time)(7 days (during one-week monitoring period))
研究者
Guzin Kaya Aytutuldu
Assistant Professor
Biruni University