跳至主要内容
临床试验/CTRI/2024/10/075512
CTRI/2024/10/075512尚未招募不适用

Development and Validation of a Hand Assessment Battery Using an Indigenous End-effector Robot System for People with Stroke

Nistara Singh Chawla1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Validity, Reliability, Sensitivity, Specificity, Responsivenes, MCID

研究概览

简要总结

A robotic system will be used for the purpose of assessment of upper extremity of individuals with stroke. The individuals would be seated comfortably and explained about the procedure. Sensory, motor and kinematic assessments will be performed. The patients will be assessed at 5 different time points for the evaluating the psychometric properties of these assessments. Validity, reliability, sensitivity, specificity, MCID and responsiveness to change will be evaluated. The values of the robotic assessments will be compared to those measured with electromagnetic trackers for reference.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Diagnosis of stroke confirmed by a neurologist; Individuals with ischaemic or haemorrhagic stroke; Ability to follow commands (MOCA more than 24).

排除标准

  • Pain in the hand equivalent or more than 3 as scored on NPRS; Spasticity in the hand of more than Grade 1+ as measured on MAS; Visual, perceptual issues, global and Wernicke’s aphasia; Premorbid hand deficits and hand deformities; Comorbid neurological/ psychiatric conditions (Parkinson disease, psychosis, etc); Any condition that precludes the opening of hand or prevent attachment of Robot to hand.

结局指标

主要结局

Validity, Reliability, Sensitivity, Specificity, Responsivenes, MCID

时间窗: once every week for 4 weeks and then after 3 months

次要结局

未报告次要终点

研究者

发起方
Nistara Singh Chawla
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nistara Singh Chawla

Manipal College of Health Professions

研究点 (1)

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