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临床试验/NCT04591132
NCT04591132Unknown不适用

Technology-based Analysis of Movement Disorders

University College, London0 个研究点目标入组 50 人开始时间: 2020年11月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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