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临床试验/NCT07425158
NCT07425158已完成不适用

Differences in Treatment Characteristics and Patient and Therapist Satisfaction Between Robot Assisted Therapy and Conventional Occupational Therapy Among Individuals Post Stroke

linor kennet1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Observation

研究概览

简要总结

The purpose of this study is to compare the differences in treatment characteristics and patient and therapist satisfaction, between Robot Assisted Therapy (RAT) and Conventional Occupational Therapy (COT) single session in individuals post stroke.

详细描述

Method and research procedure: The study will include 30 sub-acute post stroke patients, aged 18-85, with severe motor impairment in the upper limb and with normal-mild cognitive ability, hospitalized at the Loewenstein Rehabilitation Hospital. Each subject will receive two 30-min treatment sessions, one Conventional Occupational Therapy (COT) and one Robot Assisted Therapy (RAT). Before and during each session, the Visual Analogue Scale (VAS) for reporting the level of pain will be administered. The number of repetitions and compensations will be counted by observation. After each session, a subjective satisfaction questionnaire regarding the treatment will be administered.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 85 year old following stroke (first-ever stroke).
  • Individuals in the sub-acute phase (up to three months)
  • Intact cognitive function (score > 21 points on the Mini Mental State Examination)
  • Sever weakness of the affected upper limb (score 5-20 points on the FMA)
  • Understanding and reading Hebrew
  • Normal or corrected eyesight.
  • Subjects were at least in one session of RAT and one session of COT

排除标准

  • Neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restrict upper limb function.
  • High muscle tone (score > 4 in Modified Ashworth Scale)
  • Apraxia (score <68 in De Renzi Apraxia Test)
  • Severe Sensory impairment.

研究组 & 干预措施

Therapy

Other

Each subject will receive two 30-min treatment sessions, one Robot Assisted Therapy and one Conventional Occupational Therapy.

干预措施: Robot Assisted Therapy (RAT) (Other)

结局指标

主要结局

Observation

时间窗: 30 min

The number of repetitions and compensations will be counted by observation

次要结局

  • VAS(1min)
  • Questionnaire(5 min)

研究者

发起方
linor kennet
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

linor kennet

Linor Kennet

Loewenstein Hospital

研究点 (1)

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