The Effect of Art Therapy on Patients With Stroke

Ischemic Stroke and Hemorrhagic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04038424
• Other study ID #: 2019-44
• Status: Suspended
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: December 3, 2020

Study information

• Verified date: October 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Ischemic Stroke and Hemorrhagic Stroke
• Stroke

Intervention

Other:
• Art therapy
Art therapy including coloring, painting and listening to music

Locations

Country	Name	City	State
Egypt	Unit of stroke and cerebral vascular disease treatment	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Montreal Cognitive Assessment (MOCA)	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.	3 weeks
Primary	The Hospital Anxiety and Depression Scale (HADS)	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.	3 weeks
Primary	The Arm Activity (ArmA) Measure	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.	3 weeks
Secondary	The Roger's Happy Sad face	This Roger's scale will be used to assess mood, anxiety, and pain. The score ranges from 0-4, with 0 ''no symptoms'', and 4 ''worst possible symptoms''.	pre and post each session/3 weeks
Secondary	Self-efficacy and satisfaction for Art	To assess self-efficacy and perceived difficulty for art expression we will ask two single item questions. a four-point visual analogue scale with one as least confident/difficult and four as most confident/difficult. Additional question will be asked to rate the participant satisfaction with the intervention as a supportive method during their treatment.	3 weeks