Gait Characteristics and Cognitive Evolution in Parkinson Disease (GECO-PARKINSON STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Changes in Gait assessed by 6-Minute Walk Test (6MWT)
研究概览
简要总结
Parkinson's disease (PD) is a chronic progressive nervous system disease with gradual motor impairment. Cognitive dysfunction is common in PD, even in the early stages, and it is characterized by impairments in executive, attention, memory, language and visuospatial function. Motor symptoms, in particular, alterations in gait, have been studied in clinical practice to assess disease progression, and its response to treatments, both farmacological and physiotherapeutic.
Recent research on wearable technology in PD has shown that motor tests can be automated using wearable technology to eliminate human supervision and patient-reported data. Particularly, the quantitative gait analysis by using inertial devices has been proposed as a sensitive tool to longitudinally monitor gait worsening, response to dopaminergic treatment over time and cognitive dysfunction in PD patients.
The aim of this prospective multicente observational study is to investigate whether the dysfunction of specific gait parameters may be correlated to cognitive impairment (Attention/Executive Function Domain) in a cohort of ambulatory PD patients followed for 3 years.
详细描述
This is a prospective multicenter observational study with annual follow-up assessments over 3 years.
Gait is assessed by an inertial device (BTS G-WALK). G- WALK is an easy-to-use solution to obtain accurate, objective and quantitative spatial-temporal gait data. The device is a wireless system consisting of an inertial sensor composed by a triaxial accelerometer, a magnetic sensor, and a triaxial gyroscope that positioned on lumbar/ or sacral segments allows a functional gait analysis.
Cognitive performance is evaluated with a neuropsychological battery designed to assess memory, executive /attention, and visuospatial domains.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 55-74 years
- •Diagnosis of idiopathic PD based on MDS clinical diagnostic criteria
- •Hoehn & Yahr (H&Y) stages 2 to 3 at enrollment, independently by PD duration
- •Clinical-pharmacological stabilization until 3 months before the enrollment
- •DBS treatment (stable stimulation parameters until 6 months before the enrollment)
排除标准
- •Evidence of neurodegenerative and secondary parkinsonism
- •Dementia ( (score <25 on the Mini Mental State Examination - MMSE)
- •Psychiatric disorder (Beck Depression Inventory-II - BDI-II Score >19)
- •Presence of organ failure (Modified Cumulative Illness Rating Scale - CIRS > 2)
- •Orthopedic disorder or co-morbidities that may affect gait
- •Drug and alcohol use
结局指标
主要结局
Changes in Gait assessed by 6-Minute Walk Test (6MWT)
时间窗: Every year for 3 years
Gait assessment
Changes in Gait assessed by Extended-Time Up and Go (eTUG)
时间窗: Every year for 3 years
Gait assessment
Changes in cognitive function assessed by Mini-Mental State Examination (MMSE)
时间窗: Every year for 3 years
Cognitive Assessment. The MMSE score ranges from 0 to 30 points, in which a lower score indicates a higher degree of cognitive impairment.
Changes in cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
时间窗: Every year for 3 years
Cognitive Assessment. The total score of the MoCA is 30 points, with a score less than 24 is considered cognitive impairment.
Changes in cognitive function assessed by Frontal Assessment Battery (FAB)
时间窗: Every year for 3 years
Cognitive Assessment
次要结局
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale, part III(Every year for 3 years)
- "Rapid eye movement Sleep" Behavior Disorder Screening Questionnaire(Every year for 3 years)
- Hyposmia Rating Scale(Every year for 3 years)
- short Falls Efficacy Scale(Every year for 3 years)
- Berg Balance Scale(Every year for 3 years)
- Tinetti test(Every year for 3 years)
- Parkinson's Disease Questionnaire(Every year for 3 years)
- Beck Anxiety Index(Every year for 3 years)
- Beck Depression Inventory II(Every year for 3 years)