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临床试验/NCT05306522
NCT05306522招募中不适用

The Effects of Telerehabilitation-Based Spinal Stabilization Exercises on Physical Activity Level and Fatigue in Chronic Stroke Patients

Hacettepe University2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2022年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Assessment of Physical Activity Level (the mean of the number of steps)

研究概览

简要总结

Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. These symptoms can negatively affect physical activity level and fatigue. Spinal stabilization exercises based on the basic principles of motor learning improves the coordination and endurance of the body muscles by increasing kinesthetic awareness, so this exercise approach can be used to strengthen body stability. The aim of this study is to investigate the effects of telerehabilitation based spinal stabilization exercises on physical activity level and fatigue in community dwelling stroke patients.

详细描述

Stroke is defined as a neurological disorder that causes acute focal damage to the Central Nervous System due to a vascular cause. Ischemic stroke and hemorrhagic stroke are the two most fundamental types of stroke. Approximately 80% of patients suffer from ischemic stroke, whereas 20% suffer from hemorrhagic stroke. Ischemic strokes usually develop due to arterial occlusions, rarely cerebral veins or venous sinus occlusions. Hemorrhagic strokes develop as intracerebral or subarachnoid hemorrhages.

It happens as a result of a ruptured aneurysm or a ruptured cerebral artery. The clinical presentation after stroke differs according to the affected artery, underlying etiology, localization and size of the affected area. Motor, sensory and cognitive problems such as paresis, spasticity, gait and balance disorders, sensory and visual problems, fatigue, aphasia, depression, apraxia, agnosia, and amnesia may occur after stroke. These symptoms reduce the quality of life of patients and negatively affect daily living activities. In addition, as a result of all these problems, the physical activity levels of the patients decrease. These post-stroke symptoms reveal the need for rehabilitation in these patients. In the literature, there are many rehabilitation approaches after stroke. The main purpose of these approaches is to improve the functional level of patients and to ensure their independence in activities of daily living at the highest possible level.

Spinal stabilization exercises improve trunk stabilization by increasing the activation of the core muscles that wrap the trunk like a corset. The aim of spinal stabilization exercises is to strengthen core muscles, support the vertebral column, provide optimal posture by increasing kinesthetic awareness, and facilitate movements with breathing. In the literature, it has been shown that spinal stabilization exercises improve balance and gait, reduce fatigue, increase the trunk control of the patients, increase the strength of the core muscles, decrease the fear of falling, improve respiratory functions and have positive effects on activities of daily living in stroke patients.

Telerehabilitation has been one of the important research areas of stroke rehabilitation in recent years. It not only provides a treatment opportunity for patients with limited access to rehabilitation centers, but also provides an opportunity to follow-up the rehabilitation of the patients treated in the rehabilitation center after discharge. Physiotherapists reach patients with telecommunication devices (smartphone, tablet, computer) and provide online rehabilitation services.

In this study, it is aimed to increase trunk stabilization with spinal stabilization exercises. The development of trunk stabilization will reduce the load on both the trunk and the extremities, thus reducing the energy expenditure of the patients while performing their daily living activities. As a result, it is predicted that there may be an increase in the functional activity levels of the patients and a decrease in their fatigue. In the literature, there is no study in which spinal stabilization exercises were applied on the basis of telerehabilitation in stroke patients. In addition, there is no study in the literature investigating the effect of spinal stabilization exercises on the physical activity level of stroke patients. This trial is original in these respects. In this study, the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in stroke patients will be investigated.

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 (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 50-75 years
  • Having an ischemic stroke with anterior circulation involvement
  • Getting a score of 24 or higher on the Mini Mental Test
  • Ambulation in indoor and outdoor environments with or without a walking aid (walker, cane or tripod)
  • At least 1 year has passed since the stroke event
  • To have the necessary infrastructure (internet) and equipment (smartphone, tablet or computer) for the telerehabilitation application
  • Not participating in any physiotherapy program in the last 6 months
  • Volunteering to participate in the study

排除标准

  • Having a history of more than one stroke
  • Having a known orthopedic, psychiatric or other neurological disease
  • Having a history of surgery involving the lower extremities, abdominal region or gait
  • Known presence of dementia
  • Presence of aphasia and apraxia

研究组 & 干预措施

Telerehabitation Group

Experimental

Patients will undergo telerehabilitation based spinal stabilization exercise 3 days per week for 6 weeks.

干预措施: Spinal stabilization exercise (Other)

Face to face Group

Experimental

Patients will undergo spinal stabilization exercise 3 days per week for 6 weeks.

干预措施: Spinal stabilization exercise (Other)

结局指标

主要结局

Assessment of Physical Activity Level (the mean of the number of steps)

时间窗: 6 weeks

It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the number of steps taken by the users The following information will be saved: The number of steps in one day: .........steps (the mean of steps in seven days)

Assessment of Physical Activity Level (the distance of the patient walks)

时间窗: 6 weeks

It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the distance the patient walk. The following information will be saved: The distance the patients walks in one day:........meters (the mean of the distance in seven days)

Assessment of Physical Activity Level (the time the patient sleeps)

时间窗: 6 weeks

It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the time the patient sleeps. The following information will be saved: The time the patient sleeps in one day:......minutes (the mean of sleep time in seven days)

Assessment of Physical Activity Level (the calories the patient burns)

时间窗: 6 weeks

It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the calories the patients burn. The following information will be saved: he burned calories in one day:..........calories (the mean of the burned calories in seven days)

Fatigue Assessment (physical fatigue)

时间窗: 6 weeks

Fatigue will be assessed with Fatigue Severity Scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 items. Increase of the score shows severe fatigue.

Fatigue Assessment (cognitive, physical and psychosocial fatigue)

时间窗: 6 weeks

Fatigue will be assessed with Fatigue İmpact Scale (FIS). FIS is a scale with scores ranging from 0 to 160. . It includes 40 items. It has 3 subscales; cognitive fatigue (10 items), physical fatigue (10 items) and psychosocial fatigue (20 items).

Fatigue Assessment (ambulatory fatigue)

时间窗: 6 weeks

Fatigue will be assessed with linear trend of fatigue. Linear trend of fatigue is calculated from the 6 Minute Walk Test. The formula: (\[(-5\*D1)+(-3\*D2)+(-1\*D5)+(1\*D4)+(3\*D5)+(5\*D6)\])/70 (D1=1 Distance walked in 1st minute, D2=Distance walked in 2nd minute, D3=Distance walked in 3rd minute, D4= Distance walked in 4th minute, D5= Distance walked in 5th minute, D6= distance walked in 6th minute)

次要结局

  • Functional Capacity Assessment(6 weeks)
  • Trunk İmpairment Assessment(6 weeks)
  • Assessment of the Endurance of Core Muscles(6 weeks)
  • Quality of Life Assessment(6 weeks)

研究者

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

Ali Naim Ceren

Principal Investigator

Hacettepe University

研究点 (2)

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