The Effect of Art Therapy on Patients With Stroke

NCT04038424 | Not Yet Recruiting

• 1 other identifier: 2019-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke and Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• The Roger's Happy Sad face

  pre and post each session/3 weeks

• Self-efficacy and satisfaction for Art

  3 weeks

Study Arms (2)

Study group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group (n = 30) will receive only the Routine Hospital Management (RHM) and the department conventional rehabilitation activity.

Interventions

Art therapy OTHER

Art therapy including coloring, painting and listening to music

Also known as: Hand Therapy Ball Exercises

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Unit of stroke and cerebral vascular disease treatment

Cairo, Egypt

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Interventions

Art Therapy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Naglaa FA Youssef, PhD

CONTACT

00000000000; youssef_naglaa@cu.edu.eg

Naglaa FA Youssef, PhD

CONTACT

youssef_naglaa@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: July 30, 2019
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

EG (1)