Back to resultsThe Effect of Art Therapy on Patients With Stroke
Primary Purpose
Ischemic Stroke and Hemorrhagic Stroke
Status
Suspended
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Art therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Ischemic Stroke and Hemorrhagic Stroke
Eligibility Criteria
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.
Sites / Locations
- Unit of stroke and cerebral vascular disease treatment
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
The intervention group (n = 30) will receive Routine Hospital Management (RHM), conventional rehabilitation activity and AT (painting, coloring, listening to music and Hand Therapy Ball Exercises). Overall 9 sessions over a period of three weeks will be performed and each session will take around 30 min.
The control group (n = 30) will receive only the Routine Hospital Management (RHM) and the department conventional rehabilitation activity.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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''.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04038424
Brief Title
The Effect of Art Therapy on Patients With Stroke
Official Title
The Effect of Art Therapy on Cognitive Ability, Arm Activity and Mental Health Status in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Suspended
Why Stopped
Due to the Pandemic of COVID-19
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
March 3, 2020 (Actual)
Study Completion Date
December 3, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke and Hemorrhagic Stroke
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
The intervention group (n = 30) will receive Routine Hospital Management (RHM), conventional rehabilitation activity and AT (painting, coloring, listening to music and Hand Therapy Ball Exercises). Overall 9 sessions over a period of three weeks will be performed and each session will take around 30 min.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group (n = 30) will receive only the Routine Hospital Management (RHM) and the department conventional rehabilitation activity.
Intervention Type
Other
Intervention Name(s)
Art therapy
Other Intervention Name(s)
Hand Therapy Ball Exercises
Intervention Description
Art therapy including coloring, painting and listening to music
Primary Outcome Measure Information:
Title
The Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
3 weeks
Title
The Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
3 weeks
Title
The Arm Activity (ArmA) Measure
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
The Roger's Happy Sad face
Description
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''.
Time Frame
pre and post each session/3 weeks
Title
Self-efficacy and satisfaction for Art
Description
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.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Unit of stroke and cerebral vascular disease treatment
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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The Effect of Art Therapy on Patients With Stroke
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