Creative Therapy to Affect Stroke Outcomes

Phase 4

• Conditions: Stroke
• Interventions: Other: Creative therapy (art and music therapy); Other: Physical therapy

• Registration Number: NCT01455155
• Lead Sponsor: Mahidol University

Brief Summary

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.

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 Timeline

• Status Verified: 2011-10
• Study First Submitted: 2011-10-15
• Study First Submitted QC: 2011-10-15
• Last Update Submitted: 2011-10-15
• Study First Posted: 2011-10-19
• Last Update Posted: 2011-10-19
• Study Start: 2011-11
• Primary Completion: 2013-10
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Creative therapy	Creative therapy (art and music therapy)	Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks
Control	Physical therapy	Conventional physical therapy (5 times/week) for 4 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand