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临床试验/NCT04038424
NCT04038424尚未招募不适用

The Effect of Art Therapy on Cognitive Ability, Arm Activity and Mental Health Status in Patients With Stroke

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
The Montreal Cognitive Assessment (MOCA)

研究概览

简要总结

Stroke can affect the physical, emotional and social aspects of the patient and their family members. It is the main cause of complex disability, with a high number of people living with its effects. Stroke can result in impairments in motor function, language, cognition, sensory processing, cognition, and emotional disturbances, which can affect the performance of functional activities and mental health status. Getting patients involved in art therapy (AT) class has shown to alleviate stress and promote a sense of wellbeing, which can aid their recovery and rehabilitation. The benefits of art therapy for people living with different health conditions worldwide have been reported, however, its effect on Egyptian patients with stroke has been neglected.

详细描述

Art therapy refers to a group of techniques including painting, drawing and listening to music. The participants will receive the program on three steps (early step, middle step, and late step). These steps aim to train the participants on the AT from simple to complex and motivate them to engage in the AT program.Therefore, this study aims to investigate the effect of art therapy on cognitive ability, arm activity and mental health status of patients with stroke.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • able to sit upright, supported or unsupported,
  • oriented to time and place by using the adapted Arabic Memory Screening Test,
  • able to perform at least two of the following skills: drinking from a cup, eating with a spoon and taking money from a purse by the affected arm, and
  • will stay in the stroke unit to at least 4 days (for receiving three sessions out of all sessions) before discharge,

排除标准

  • diagnosis of transient ischemic attack or brain stem stroke;
  • unconscious;
  • unable to provide informed consent;
  • hemodynamical unstable medical conditions, including fever;
  • serious infectious diseases, for example, viral hepatitis or HIV; and/or
  • severe dementia or uncontrolled psychiatric problems.

结局指标

主要结局

The Montreal Cognitive Assessment (MOCA)

时间窗: 3 weeks

The Montreal Cognitive Assessment is a 16-item screening assessment for mild cognitive impairment. It is widely used in stroke survivors and assesses performance attention, concentration, executive functions, memory, language, visual-constructional skills, conceptual thinking, calculations and orientation. The maximum score is 30 and scores of under 26 indicate cognitive impairment.

The Hospital Anxiety and Depression Scale (HADS)

时间窗: 3 weeks

This measurement consists of two subscales: Anxiety subscale (HADS-A) and a depression subscale (HADS-D) with 14 intermingled items. Each item is rated on a four-point scale of 0-3, giving maximum scores of 21 for anxiety and depression respectively. Scores of 11 or more on either subscale are considered as significant 'case' of psychological comorbidity, a score of 8-10 as borderline while a score of 7 or below is considered as normal.

The Arm Activity (ArmA) Measure

时间窗: 3 weeks

The ArmA measure is a patient and/or career-reported 20-item measure of difficulty in passive and active hemiparetic arm function. It consists of a seven-item passive function subscale, and 13-item active function subscale. Using a Likert scoring system between zero (no difficulty) and four (unable to do task). The passive function subscale scores range from zero (high function) to 28 and the active function subscale scores range from zero (high function) to 52.

次要结局

  • The Roger's Happy Sad face(pre and post each session/3 weeks)
  • Self-efficacy and satisfaction for Art(3 weeks)

研究者

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

Naglaa Fathy Afifi Youssef

Professor

Cairo University

研究点 (2)

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