Creative Therapy to Affect Stroke Outcomes

This study is not yet open for participant recruitment.
Verified October 2011 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01455155
First received: October 15, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted

October 15, 2011
October 15, 2011
November 2011
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • Barthel index (BI) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The creative therapy will be considered success if the pictorial Thai Quality of Life score increases after 4-week of treatment.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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.
  • 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).
  • Experimental: Creative therapy
    Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks
    Intervention: Other: Creative therapy (art and music therapy)
  • Active Comparator: Control
    Conventional physical therapy (5 times/week) for 4 weeks
    Intervention: Other: Physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
204
May 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 85 Years
No
Contact: Vilai Kuptniratsaikul, MD 662-419-7511 ext - sivkp@mahidol.ac.th
Thailand
 
NCT01455155
Si290/2011
No
Mahidol University
Mahidol University
Not Provided
Principal Investigator: Vilai Kuptniratsaikul, MD Mahidol University
Mahidol University
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP