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The Effect of Home-Based Telerehabilitation in Individuals With Stroke

2021年10月8日 更新者:Recep Ormen、Istanbul University - Cerrahpasa (IUC)

The Effect of Individualized Home-Based Telerehabilitation Intervention on Physical Parameters and Activities of Daily Living in Individuals With Stroke

Stroke is a clinical picture that develops due to occlusion or rupture of cerebral vessels and results in loss of cerebral functions. Stroke individuals face some limitations in managing daily activities such as walking, dressing, feeding and showering. Personal, environmental, and societal limitations have led to the development of new treatment strategies, such as telerehabilitation(TR), to meet the needs of stroke individuals and their caregivers.

In this study, patients will be randomized and divided into 2 groups in order to examine the effects of two different TR methods on physical parameters and activities of daily living in stroke patients. Baseline assessments will be made for both groups to determine functionality, activities of daily living, fall activity, quality of life, and level of fatigue. For 8 weeks, the TR group will do their exercises with exercise videos prepared on the system 3 times a week. The control group, on the other hand, will do their exercises with exercise brochures on the system 3 times a week for 8 weeks. After 8 weeks, assessments will be repeated. With telerehabilitation to be applied to individuals with stroke, it is aimed to increase functional capacity, independence in daily living activities and quality of life, and reduce the number of falls and fatigue levels.

研究概览

研究类型

介入性

注册 (预期的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Recep Ormen, M.Sc
  • 电话号码:+905316777334
  • 邮箱:rormen@gmail.com

学习地点

    • Bakirkoy
      • Istanbul、Bakirkoy、火鸡、34100
        • 招聘中
        • Istanbul University-Cerrahpaşa
        • 副研究员:
          • Yonca Zenginler Yazgan, PhD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Diagnosed with stroke at least 1 year ago by a neurologist
  • Modified Rankin score ≤3
  • Have an internet infrastructure that can be accessed at home
  • Not participated in a standardized physiotherapy program in the past 3 months

Exclusion Criteria:

  • Presence of blurred or low vision problems
  • Hearing and speech impairment at a level that will affect participation in the system
  • Epilepsy
  • Presence of pregnancy
  • Having any cognitive problems that prevent using the system

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Telerehabilitation Group
This group will perform their exercises with pre-prepared personalized exercise videos over the telerehabilitation system 3 times a week for 8 weeks.
Balance, walking, strengthening exercise videos etc. taken in different positions will be uploaded to the telerehabilitation system. A personalized exercise program will be created from these exercises. This program will be defined to the account of the patient and the follow-up of the person will be carried out through the system.
实验性的:Control Group
This group will perform exercises with personalized exercise brochures defined over the telerehabilitation system 3 times a week for 8 weeks.
Photos and explanations of exercises taken in different positions such as balance, walking, strengthening etc. will be uploaded to the telerehabilitation system. A personalized exercise brochure will be created from these exercises. This program will be defined for the patient's account and the patient will be asked to follow the exercises with this brochure.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It is a functional assessment test that measures the patient's standing balance on one leg. It is applied for both legs of the patient with eyes open and closed.
Baseline and end of weeks 8
Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
This test assesses functional lower extremity strength, transfer, balance, and fall risk. The time the patient sits and stands up from the chair 5 times is recorded.
Baseline and end of weeks 8
Romberg Test (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
The patient's standing time is recorded in an upright position with her feet open at shoulder level and arms free at the side of the body, with her eyes open and then closed, without losing her balance.
Baseline and end of weeks 8
Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It tests the patient's ability to stand in an upright position without any support or assistance, with her feet shoulder-width apart and arms free at the side of the body.
Baseline and end of weeks 8
Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It is a scale that measures the patient's ability to perform activities of daily living independently and evaluates the functional status.
Baseline and end of weeks 8

次要结果测量

结果测量
措施说明
大体时间
Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It is a 14-item scale that measures the patient's confidence in falling.
Baseline and end of weeks 8
WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It is a health-related quality of life scale developed by the World Health Organization. A national question was added to the Turkish version of the scale in addition to the original version.
Baseline and end of weeks 8
Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)
大体时间:Baseline and end of weeks 8
It is a scale that evaluates the severity of fatigue with 9 items that patients can answer on their own.
Baseline and end of weeks 8
Global Rating of Change Scales
大体时间:End of weeks 8
It is a scale that evaluates how much the patient's current condition has changed compared to previous condition.
End of weeks 8
System Usability Scale
大体时间:End of weeks 8
It is a scale consisting of 10 questions widely used in the literature to evaluate the perceptibility and usability of interactive systems.
End of weeks 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Yonca Zenginler Yazgan, PhD、Istanbul University-Cerrahpasa Faculty of Health Science
  • 首席研究员:Recep Ormen, M.Sc、Istanbul University-Cerrahpasa Institute of Postgraduate Education

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月4日

初级完成 (预期的)

2022年8月4日

研究完成 (预期的)

2022年12月28日

研究注册日期

首次提交

2021年10月8日

首先提交符合 QC 标准的

2021年10月8日

首次发布 (实际的)

2021年10月19日

研究记录更新

最后更新发布 (实际的)

2021年10月19日

上次提交的符合 QC 标准的更新

2021年10月8日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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