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临床试验/NCT04637100
NCT04637100撤回不适用

Effect of Free Mobile or Tablet-based Applications on Stroke-Related Cognitive Impairment in Inpatient Rehabilitation

Loma Linda University2 个研究点 分布在 1 个国家开始时间: 2021年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)

研究概览

简要总结

The investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. This is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.

详细描述

Study subjects will be randomized to a control or experimental group and allocation will be concealed. The experimental group will consist of the subject utilizing their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily. The control group will utilize their personal mobile or tablet device to perform the non-problem-solving task of watching educational videos of their choice from a pre-selected set of videos for the same amount of time daily. The intervention gaming arm will be provided different gaming apps if they lose interest or find a particular game too easy or too difficult. The control video arm will be provided different educational videos according to their needs that may change throughout their inpatient stay.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized at Loma Linda East Campus Rehabilitation Hospital
  • First time stroke patient
  • mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation
  • Have daily access while inpatient to a personally owned Apple or Android smartphone or tablet device prior to the initial session.

排除标准

  • Unable to understand and follow verbal and written instructions in English
  • Presence of aphasia that limits device use or ability to provide consent
  • Presence of pre-stroke speech, language, or cognitive disorder
  • Unable to operate device due to cognitive, physical, or visual impairment

结局指标

主要结局

Scales of Cognitive and Communicative Ability for Neurorehabilitation (SCCAN)

时间窗: From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks

Assesses cognitive-communicative deficits and functional ability in patients in rehabilitation hospitals, clinics, and skilled nursing facilities. The SCCAN contents relate to daily activities that adults would be expected to perform for independent living. The SCCAN has eight scales and a total score: Oral Expression, Orientation, Memory, Speech Comprehension, Reading Comprehension, Writing, Attention, Problem Solving Typical functioning = 87-94 Mild impairment = 69-86 Moderate impairment = 47-68 Severe impairment = 0-46

次要结局

  • Montreal Cognitive Assessment (MOCA)(From date of randomization until the day of discharge, assessed at beginning and end of this period, up to 5 weeks)
  • Modified Gaming Engagement Questionnaire(From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.)
  • Program Evaluation(From date of randomization until the day of discharge, assessed at end of this period, up to 5 weeks. Qualitative feedback only.)

研究者

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

Christopher Tarver

Assistant Professor

Loma Linda University

研究点 (2)

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