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临床试验/NCT05083195
NCT05083195Unknown不适用

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

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Single Leg Stance Test (The change between the initial value and the value after 2 months will be evaluated)

时间窗: 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.

Five Times Sit to Stand Test (The change between the initial value and the value after 2 months will be evaluated)

时间窗: 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.

Romberg Test (The change between the initial value and the value after 2 months will be evaluated)

时间窗: 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.

Independent Standing test (The change between the initial value and the value after 2 months will be evaluated)

时间窗: 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.

Katz Index of Independence in Activities of Daily Living (The change between the initial value and the value after 2 months will be evaluated)

时间窗: 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.

次要结局

  • Global Rating of Change Scales(End of weeks 8)
  • System Usability Scale(End of weeks 8)
  • Modified Falls Efficacy Scale (The change between the initial value and the value after 2 months will be evaluated)(Baseline and end of weeks 8)
  • WHOQOL-BREF-TR (The change between the initial value and the value after 2 months will be evaluated)(Baseline and end of weeks 8)
  • Fatigue Severity Scale (The change between the initial value and the value after 2 months will be evaluated)(Baseline and end of weeks 8)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Recep Ormen

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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