A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 5
- 主要终点
- Rotation Time
研究概览
简要总结
The present study aims to use the SensMode System - a system composed of wearable devices for upper and lower limb movement analysis and electronic device for data acquisition and processing - on healthy subjects, subjects with idiopathic hyposmia, patients with Parkinson's disease, and subjects with de-novo drug-naïve extrapyramidal syndrome. The purpose is to identify normative data of objective motor measures obtained with such a system, as well as to increase knowledge about the potential contribution such a solution can make to the preclinical diagnosis of Parkinson's disease and the management of patients with this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects - Inclusion Criteria:
- •Adult subjects, both sexes, aged 50-80 years old
- •MMSE score >= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score <=5; age class 60-69 years: normal with score <=6; age class > 70 years: normal with score <=7
- •absence of neurological diseases
- •absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
- •expression of informed consent to participate in the study
- •Subjects with Parkinson's disease -- Inclusion criteria:
- •adult subjects, both sexes, 50-80 years of age
- •MMSE score >= 24
- •subjects with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or subjects with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the absence of dyskinesias
- •Hoehn and Yahr stage 1, 2, 3
- •absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
- •expression of informed consent to participate in the study
排除标准
- •Healthy subjects - Exclusion criteria:
- •denial of informed consent to participate in the study
- •Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score >=6; age class 60-69 years: hyposmia with score >=7; age class > 70 years: hyposmia with score >=8
- •body weight greater than 120 kg
- •insufficient degree of cooperation
- •malignant neoplasm in progress or with negative follow-up of less than 6 years
- •structured joint stiffness in the upper and/or lower extremities preventing proper execution of movements
- •paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury
- •mono/multi/poly sensory and/or motor neuropathy
- •chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
- •vertiginous syndromes in the acute phase
- •neurodegenerative diseases
- •venous thrombosis
- •cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
- •spinal or joint pain of various etiologies that may affect the performance of motor exercises
- •positive history of recurrent acute cervico-brachialgia and/or lumbosciatica
- •Subjects with Parkinson's disease - Exclusion criteria:
- •Denial of informed consent to participate in the study
- •Hoenn and Yahr stage 4, 5
- •Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person
- •body weight greater than 120 kg
- •insufficient degree of cooperation
- •malignant neoplasm in place or with negative follow-up of less than 6 years
- •structured joint stiffness in the upper and/or lower extremities that prevents proper execution of movements
- •paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury mono/multi/poly sensory and/or motor neuropathy
- •chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
- •vertiginous syndromes in the acute phase
- •neurodegenerative diseases, excluding Parkinson's disease
- •venous thrombosis
- •cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
- •spinal or joint pain of various etiologies that may affect the performance of motor exercises
- •positive history of recurrent acute cervico-brachialgia and/or low back pain
研究组 & 干预措施
Motor Data Analysis for Healthy Subjects
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
干预措施: Motor Data Analysis (Device)
Motor Data Analysis for patients with Parkinson's disease
All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement
干预措施: Motor Data Analysis (Device)
结局指标
主要结局
Rotation Time
时间窗: at Enrollment (T0)
Time to perform a turning of 360°
Number of repetitions
时间窗: at Enrollment (T0)
Number of repetitions in Finger Tapping task
Fundamental frequency of accelerometer signal
时间窗: At enrollment (T0)
Fundamental frequency of accelerometer signal for hands resting tremor task
Time to Stand Up
时间窗: at Enrollment (T0)
Time to stand up from a chair
Gait Time
时间窗: at Enrollment (T0)
Time to walk for 15 meters straight on
Strides Number
时间窗: at Enrollment (T0)
Number of strides to walk for 15 meters straight on
次要结局
未报告次要终点
研究者
Filippo Cavallo
Associate Professor
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna