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
  Purpose

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 Intervention Phase
Stroke
Other: Creative therapy (art and music therapy)
Other: Physical therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Creative Therapy for Stroke Patients

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 204
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455155

Contacts
Contact: Vilai Kuptniratsaikul, MD 662-419-7511 ext - sivkp@mahidol.ac.th

Locations
Thailand
Faculty of Medicine Siriraj Hospital Not yet recruiting
Bangkok, Thailand, 10700
Contact: Vilai Kuptniratsaikul, MD    662-419-7511 ext -    sivkp@mahidol.ac.th   
Principal Investigator: Vilai Kuptniratsaikul, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Vilai Kuptniratsaikul, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01455155     History of Changes
Other Study ID Numbers: Si290/2011
Study First Received: October 15, 2011
Last Updated: October 15, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
stroke
Art therapy
Music therapy
Creative therapy
Efficacy

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014