Clinical trial NCT01455155: Creative Therapy to Affect Stroke Outcomes
Official title: Efficacy of Creative Therapy for Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Keywords: stroke
Art therapy
Music therapy
Creative therapy
Efficacy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Abbreviated Mental Score test (AMS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Barthel index (BI)
timeFrame: 4 weeks
measure: Hospital anxiety depression score (HADS)
timeFrame: 4 weeks
measure: Pictorial Thai Quality of Life score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Vilai Kuptniratsaikul, MD
role: PRINCIPAL_INVESTIGATOR
References: