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The Effect of Art Therapy on Patients With Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038424
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Naglaa Fathy Afifi Youssef, Cairo University

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke and Hemorrhagic Stroke Other: Art therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Art Therapy on Cognitive Ability, Arm Activity and Mental Health Status in Patients With Stroke
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
Experimental: Study group
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.
Other: Art therapy
Art therapy including coloring, painting and listening to music
Other Name: Hand Therapy Ball Exercises

No Intervention: Control group
The control group (n = 30) will receive only the Routine Hospital Management (RHM) and the department conventional rehabilitation activity.



Primary Outcome Measures :
  1. The Montreal Cognitive Assessment (MOCA) [ Time Frame: 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.

  2. The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.

  3. The Arm Activity (ArmA) Measure [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Roger's Happy Sad face [ Time Frame: pre and post each session/3 weeks ]
    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''.

  2. Self-efficacy and satisfaction for Art [ Time Frame: 3 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038424


Contacts
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Contact: Naglaa F Youssef, PhD 00201149495552 youssef_naglaa@cu.edu.eg
Contact: Naglaa F Youssef, PhD 00201149495552 youssef_naglaa@homtail.com

Locations
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Egypt
Unit of stroke and cerebral vascular disease treatment Recruiting
Cairo, Egypt
Contact: Ahmed Abdelalem, Professor         
Sponsors and Collaborators
Cairo University
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Responsible Party: Naglaa Fathy Afifi Youssef, Associate professor, Cairo University
ClinicalTrials.gov Identifier: NCT04038424    
Other Study ID Numbers: 2019-44
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases