Creative Therapy to Affect Stroke Outcomes
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|ClinicalTrials.gov Identifier: NCT01455155|
Recruitment Status : Unknown
Verified October 2011 by Mahidol University.
Recruitment status was: Not yet recruiting
First Posted : October 19, 2011
Last Update Posted : October 19, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Creative therapy (art and music therapy) Other: Physical therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Creative Therapy for Stroke Patients|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||May 2014|
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).
- Abbreviated Mental Score test (AMS) [ Time Frame: 4 weeks ]The creative therapy will be considered success if the AMS increases after 4-week of treatment.
- Barthel index (BI) [ Time Frame: 4 weeks ]The creative therapy will be considered success if the BI score increases after 4-week of treatment.
- Hospital anxiety depression score (HADS) [ Time Frame: 4 weeks ]The creative therapy will be considered success if the HADS decreases after 4-week of treatment.
- Pictorial Thai Quality of Life score [ Time Frame: 4 weeks ]The creative therapy will be considered success if the pictorial Thai Quality of Life score increases after 4-week of treatment.
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): NCT01455155
|Contact: Vilai Kuptniratsaikul, MDfirstname.lastname@example.org|
|Faculty of Medicine Siriraj Hospital||Not yet recruiting|
|Bangkok, Thailand, 10700|
|Contact: Vilai Kuptniratsaikul, MD 662-419-7511 email@example.com|
|Principal Investigator: Vilai Kuptniratsaikul, MD|
|Principal Investigator:||Vilai Kuptniratsaikul, MD||Mahidol University|