Creative Therapy to Affect Stroke Outcomes

Efficacy of Creative Therapy for Stroke Patients

Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. The focal brain lesions encountered in patients with stroke can result in impairments in motor function, language, cognition, sensory processing, cognition and emotional disturbances. All of these conditions affect performance of functional activities. The abrupt change in the life situation of the stroke survivor impacts all phases of care. This may reduce a patient's quality of life.

Many innovative therapy techniques have been developed to help the restoration of lost functions and to aid in prevention and treatment of depression. Music and art therapy has been used in rehabilitation settings to stimulate brain functions involved in movement, cognition, speech, emotions, and sensory perceptions. However many research studies on the use of music and art therapy in rehabilitation of acquired brain injury have suffered from small sample size, making it difficult to achieve statistically significant results. In addition, differences in factors such as study designs, methods of interventions, and intensity of treatment have led to varying results.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: Creative therapy (art and music therapy); Other: Physical therapy

Detailed Description

Our study focuses on the use of creative therapy with a patient diagnosed with stroke. Creative therapy refers to a group of techniques include art therapy, writing, movement therapy, role play, and music therapy that are expressive and creative in nature. The aim of creative therapies is to help patients find a form of expression beyond words or traditional therapy, such as cognitive or psychotherapy. These therapies use arts modalities and creative processes during intentional intervention in therapeutic, rehabilitative, community, or educational settings to foster health, communication, and expression.

• Study Type: Interventional
• Enrollment (Anticipated): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Stroke patients
• Duration of stroke >=1 month
• Age >=50 years
• Ability to follow command and communicable

Exclusion Criteria:

• Unstable medical conditions, including fever, uncontrolled hypertension
• Serious contact diseases, for example AIDS, TB
• Severe dementia or uncontrolled psychiatric problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Creative therapy; Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks	Other: Creative therapy (art and music therapy); Creative therapy composed of groups of activities relating to music and art sciences 8 sessions (2 sessions per week for 4 weeks) These activities emphasized on stimulating of cognition, physical, emotion, communication, social relationship, and spiritual domains.
Active Comparator: Control; Conventional physical therapy (5 times/week) for 4 weeks	Other: Physical therapy; Physical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated Mental Score test (AMS)	The creative therapy will be considered success if the AMS increases after 4-week of treatment.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel index (BI)	The creative therapy will be considered success if the BI score increases after 4-week of treatment.	4 weeks
Hospital anxiety depression score (HADS)	The creative therapy will be considered success if the HADS decreases after 4-week of treatment.	4 weeks
Pictorial Thai Quality of Life score	The creative therapy will be considered success if the pictorial Thai Quality of Life score increases after 4-week of treatment.	4 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Vilai Kuptniratsaikul, MD, Mahidol University

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: October 15, 2011
• First Submitted That Met QC Criteria: October 15, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): October 19, 2011
• Last Update Submitted That Met QC Criteria: October 15, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: stroke; Efficacy; Music therapy; Art therapy; Creative therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Si290/2011