CClinicalTrials.gg
Status unknownNCT01455155Updated Oct 19, 2011

Creative Therapy to Affect Stroke Outcomes

A Phase 4 interventional study of Creative therapy (art and music therapy) and Physical therapy in Stroke, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-10-19.

Sponsored by Mahidol University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke
  • Art therapy
  • Music therapy
  • Creative therapy
  • Efficacy
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 204 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Stroke patients
  • Duration of stroke >=1 month
  • Age >=50 years
  • Ability to follow command and communicable

Exclusion criteria

Exclusion Criteria:

  • Unstable medical conditions, including fever, uncontrolled hypertension
  • Serious contact diseases, for example AIDS, TB
  • Severe dementia or uncontrolled psychiatric problems
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
204 participants (estimated)

Study arms

  • 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)

  • Active comparator
    Control

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

    Other: Physical therapy

Interventions

  • OtherCreative 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.

  • OtherPhysical therapy

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

06

What researchers measure

Primary outcomes

  1. Abbreviated Mental Score test (AMS)

    The creative therapy will be considered success if the AMS increases after 4-week of treatment.

    Time frame: 4 weeks

Secondary outcomes

  1. Barthel index (BI)

    The creative therapy will be considered success if the BI score increases after 4-week of treatment.

    Time frame: 4 weeks

  2. Hospital anxiety depression score (HADS)

    The creative therapy will be considered success if the HADS decreases after 4-week of treatment.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

07

Study locations

1 site
  • Faculty of Medicine Siriraj Hospital
    Bangkok, 10700, Thailand
    • Vilai Kuptniratsaikul, MD · Contact · sivkp@mahidol.ac.th · 662-419-7511
    • Vilai Kuptniratsaikul, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01455155
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Oct 19, 2011
Start date
Nov 2011
Primary completion
Oct 2013 (estimated)
Completion
May 2014 (estimated)
Last update
Oct 19, 2011

Study contacts

Vilai Kuptniratsaikul, MD
Contact
sivkp@mahidol.ac.th
662-419-7511
Vilai Kuptniratsaikul, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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