Creative Therapy to Affect Stroke Outcomes

Stroke Clinical Trial

Official title:

Efficacy of Creative Therapy for Stroke Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01455155
• Other study ID #: Si290/2011
• Status: Unknown status
• Phase: Phase 4
• First received: October 15, 2011
• Last updated: October 15, 2011
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: October 2011
• Source: Mahidol University
• Contact: Vilai Kuptniratsaikul, MD
• Phone: 662-419-7511
• Email: sivkp[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 204
• Est. completion date: May 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Physical therapy
Physical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week).

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abbreviated Mental Score test (AMS)	The creative therapy will be considered success if the AMS increases after 4-week of treatment.	4 weeks
Secondary	Barthel index (BI)	The creative therapy will be considered success if the BI score increases after 4-week of treatment.	4 weeks
Secondary	Hospital anxiety depression score (HADS)	The creative therapy will be considered success if the HADS decreases after 4-week of treatment.	4 weeks
Secondary	Pictorial Thai Quality of Life score	The creative therapy will be considered success if the pictorial Thai Quality of Life score increases after 4-week of treatment.	4 weeks