跳至主要内容
临床试验/NCT04901637
NCT04901637Unknown不适用

Musculoskeletal Problems in Caregivers of Stroke Survivors

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Extended Nordic Musculoskeletal Questionnaire

研究概览

简要总结

Stroke is one of the major causes of neurological disability in adults globally. Fifteen million patients suffer from stroke annually throughout the world, from which 5 million had to continue to live with a major disability. Especially in developing and non-developing countries, it contributes significantly to the mortality and morbidity.

The improvements in medical care of acute stroke, especially in a specialized stroke unit setting, reduced overall mortality of the disease. However, the general prognosis of stroke survivors did not improve accordingly, so that many survivors have to deal with different forms of disability. Following a stroke, patients usually suffer from variable degrees of disability. They require acute treatment at an inpatient setting and extensive assistance throughout their recovery at home. Most stroke survivors depend on informal caregivers, who usually is a family member (eg, spouse) providing unpaid care for the patient.Caregivers are usually unprepared and unfit for such a support after discharge. And as a result, they may experience a decline in their physical and mental health status, social life and general well-being

The current study sought to examine the musculoskeletal problems of the informal caregivers in relation with the physical condition and the degree of disability of the patient they are caring. To our knowledge this study can be considered as the first of its kind by evaluating the symptoms of the caregiver from their viewpoint and relates the level of their symptoms to the level of incapacity of the stroke patient.

详细描述

In our observational study, we evaluated the cross-sectional survey data of the informal caregivers who had provided care for stroke patients. The convenience sampling method was used to assemble the study population. Consecutive informal caregivers accompanying stroke survivors to the outpatient stroke clinic at Kanuni Sultan Süleyman Training and Research Hospital, Istanbul, Turkey were included in our study.

Patients were eligible if they (1) had a stroke according to the WHO definition at least 6 months prior, who need assistance with the activities of daily life(ADL) and are older than 18 years of age.

The informal caregivers over the age of 18, who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance were included in the study. Caregivers, who are above the age of 65, who have underlying comorbid illnesses, neurological disability, or psychiatric disabilities that would hinder their capacity to deliver care were removed from the study. Because of the negative effects of aging on the musculoskeletal system, caregivers over 65 years of age were also excluded.

Data forms, designed by the researchers, were used to record information on each caregiver's age, gender, educational level, employment status, and relationship with stroke survivor. Respective stroke survivors' data were also recorded.

Validated scales were used to assess the physical condition and disability levels of stroke survivors. Modified Ashworth Scale (MAS) was used to quantify the spasticity of the upper and the lower extremity muscles. MAS is a 6-point rating scale. The lowest score is 0 and means "no increase in muscle tone," while the highest score 4 shows that the affected limb is rigid during flexion or extension

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • For stroke survivors:
  • Patients were eligible if they had a stroke according the WHO definition at least 6 months prior,
  • Who need assistance with the activities of daily life(ADL)
  • Older than 18 years of age
  • For caregivers:
  • Older than 18 years of age
  • Who have cared for a stroke victim for at least 6 months, and provided some basic ADL assistance

排除标准

  • For caregivers:
  • Who are above the age of 65

结局指标

主要结局

Extended Nordic Musculoskeletal Questionnaire

时间窗: 1 interview day

The effect of musculoskeletal symptoms during the last 6 months was evaluated using the NMQ-E, which is a one-page survey evaluating nine body regions: hand/wrist, elbow, shoulder, neck, upper back, low back, hip/thigh, knee and foot/ankle.Responses were provided as 'trouble, including ache, pain and discomfort'.Only musculoskeletal symptoms (affecting joints, muscles, and bones) were asked about in order to rule out other symptoms like neuropathic or abdominal pain.

Caregiver Burden Inventory

时间窗: 1 interview day

BI is a self-administered 24-item questionnaire with five domains: time dependency, developmental, physical, social, and emotional pressures. All objects are scored on a 5-point Likert scale, with 0 being the least disruptive (not at all disruptive) and 4 being the most disruptive (very disruptive). The global score is calculated by adding the subscale scores together. Greater caregiver burden is shown by higher ratings

次要结局

未报告次要终点

研究者

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

Tugba Sahbaz

Medical Doctor

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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