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临床试验/NCT05193539
NCT05193539已完成不适用

Effects of Comprehensive Augmented and Virtual Reality for Upper Limb Rehabilitation in First-Ever Stroke Patients

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Fugl-Meyer Assessment for Upper Extremity score

研究概览

简要总结

The purpose of this study was to assess the efficacy of augmented and virtual reality-based rehabilitation programs on improving upper extremity function in subacute stroke patients.

详细描述

This was a randomized, single-blinded study, conducted at a single acute rehabilitation unit in a university hospital. In this study, the effect of augmented and virtual reality-based rehabilitation for the recovery of subacute stroke patients compared with conventional occupational therapy was evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The researcher responsible for randomization was independent from the assessors, assuring blindness to treatment allocation and randomization procedures. The blinded assessor performed the baseline and post-treatment assessments. The patients and the occupational therapists were not blinded due to the nature of treatment modality.

入排标准

性别
All
接受健康志愿者

入选标准

  • First ever stroke
  • Onset of stroke less than 3 months
  • Sufficiently medically stable to participate in active rehabilitation
  • Mild-to-moderate upper extremity motor impairments (Brunnstrom stage for the upper extremity 2-6).

排除标准

  • Severe cognitive impairment (defined as score < 10 on the Mini-Mental State Examination)
  • Evidence of apraxia
  • Clinical history of neglect
  • Previous upper extremity hemiplegia.

结局指标

主要结局

Fugl-Meyer Assessment for Upper Extremity score

时间窗: 2 weeks after intervention

range (0-126), higher scores mean a better motor function

次要结局

  • EuroQol Visual Analogue Scale(2 weeks after intervention)
  • Berg Balance Scale(2 weeks after intervention)
  • Grip strength (kg)(2 weeks after intervention)
  • Box and Block Test(2 weeks after intervention)
  • Modified Barthel Index(2 weeks after intervention)
  • Motor Activity Log of Amount of Use and Quality of Movement(2 weeks after intervention)
  • Hand response reaction time(2 weeks after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Geol Do

M.D, PhD, Assistant professor

Samsung Medical Center

研究点 (1)

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