Technology-based Analysis of Movement Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- gait metrics
研究概览
简要总结
Objectives: To generate pilot data to investigate the feasibility and the potential use in clinical practice of technology based objective measures of motor performances in patients affected by different movement disorders. To correlate kinematics findings with demographic and clinical details. Trial design and methods: Participants enrolled in prof. Bhatia's movement disorders clinic, will be classifies according to the main movement disorder, specifically, tremor, parkinsonism, dystonia, chorea, ataxia. In the study visit (one day only), they will undergo a clinical evaluation using the appropriate clinical scales (respectively, Fahn-Tolosa-Marin tremor rating scale, MDS-UPDRS Part III, Toronto Western Spasmodic Torticollis Rating Scale 2, Unified Hungtington Disease Rating scale and Scale for the Assessment and Rating of Ataxia) and a kinematic evaluation, using wearables and an infra-red and LED markers system. Then the protocol is concluded and they will continue the routine clinical follow-up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:
- •idiopatic parkinson's disease
- •atypical parkinsonism
- •sporadic or inherited/genetic dystonia
- •young-onset Parkinson's disease
- •Ataxia syndrome
- •Choereic syndrome
- •Essential tremor
- •Dystonic tremor
- •18 to 80 years of age
- •Willing and able to provide informed consent
- •able to walk unassisted
排除标准
- •Change in pharmacological therapy in the last 3 months.
- •Participated in a clinical drug trial up to 3 months before inclusion into the present study
- •Orthopaedical comorbidities affecting gait or posture.
- •Cognitive deficit
结局指标
主要结局
gait metrics
时间窗: up to 6 weeks after enrolment
gait cycles measures (step length, phase duration, number of steps) practice of technology based objective measures of motor performances in patients affected by different movement disorders, to objectively evaluate the disease burden, the efficacy of therapeutic interventions and having a deeper phenotyping of motor disabilities.
neck ROM
时间窗: up to 6 weeks after enrolment
range of motion of the neck in x,y and z axis
bradykinesia evaluation
时间窗: up to 6 weeks after enrolment
amplitude of repeated limb movements over time
tremor peak frequence
时间窗: up to 6 weeks after enrolment
fourier analysis for peak frequence of tremor
次要结局
- correlation with UPDRS gait Item(up to 6 weeks after enrolment)
