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Creative Therapy to Affect Stroke Outcomes

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Creative therapy (art and music therapy)
Physical therapy
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, Art therapy, Music therapy, Creative therapy, Efficacy

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Creative therapy

Control

Arm Description

Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks

Conventional physical therapy (5 times/week) for 4 weeks

Outcomes

Primary Outcome Measures

Abbreviated Mental Score test (AMS)
The creative therapy will be considered success if the AMS increases after 4-week of treatment.

Secondary Outcome Measures

Barthel index (BI)
The creative therapy will be considered success if the BI score increases after 4-week of treatment.
Hospital anxiety depression score (HADS)
The creative therapy will be considered success if the HADS decreases after 4-week of treatment.
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.

Full Information

First Posted
October 15, 2011
Last Updated
October 15, 2011
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01455155
Brief Title
Creative Therapy to Affect Stroke Outcomes
Official Title
Efficacy of Creative Therapy for Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Art therapy, Music therapy, Creative therapy, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Creative therapy
Arm Type
Experimental
Arm Description
Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional physical therapy (5 times/week) for 4 weeks
Intervention Type
Other
Intervention Name(s)
Creative therapy (art and music therapy)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Physical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week).
Primary Outcome Measure Information:
Title
Abbreviated Mental Score test (AMS)
Description
The creative therapy will be considered success if the AMS increases after 4-week of treatment.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Barthel index (BI)
Description
The creative therapy will be considered success if the BI score increases after 4-week of treatment.
Time Frame
4 weeks
Title
Hospital anxiety depression score (HADS)
Description
The creative therapy will be considered success if the HADS decreases after 4-week of treatment.
Time Frame
4 weeks
Title
Pictorial Thai Quality of Life score
Description
The creative therapy will be considered success if the pictorial Thai Quality of Life score increases after 4-week of treatment.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vilai Kuptniratsaikul, MD
Phone
662-419-7511
Email
sivkp@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilai Kuptniratsaikul, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vilai Kuptniratsaikul, MD
Phone
662-419-7511
Email
sivkp@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Vilai Kuptniratsaikul, MD

12. IPD Sharing Statement

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Creative Therapy to Affect Stroke Outcomes

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