Creative Therapy to Affect Stroke Outcomes
| Tracking Information | |||||
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| First Received Date ICMJE | October 15, 2011 | ||||
| Last Updated Date | October 15, 2011 | ||||
| Start Date ICMJE | November 2011 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Abbreviated Mental Score test (AMS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ] The creative therapy will be considered success if the AMS increases after 4-week of treatment. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Creative Therapy to Affect Stroke Outcomes | ||||
| Official Title ICMJE | Efficacy of Creative Therapy for Stroke Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Stroke | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 204 | ||||
| Estimated Completion Date | May 2014 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01455155 | ||||
| Other Study ID Numbers ICMJE | Si290/2011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mahidol University | ||||
| Study Sponsor ICMJE | Mahidol University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mahidol University | ||||
| Verification Date | October 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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