StrokePhase 4NCT01455155
Creative Therapy to Affect Stroke Outcomes
A Phase 4 study testing Creative therapy (art and music therapy) and Physical therapy in people with Stroke, run by Mahidol University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Creative therapy (art and music therapy) and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2011to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients
- Duration of stroke >=1 month
- Age >=50 years
- Ability to follow command and communicable
Who cannot join
- Unstable medical conditions, including fever, uncontrolled hypertension
- Serious contact diseases, for example AIDS, TB
- Severe dementia or uncontrolled psychiatric problems
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkok, 10700
Vilai Kuptniratsaikul, MD, 662-419-7511, sivkp@mahidol.ac.th
Vilai Kuptniratsaikul, MD
About this study
Official title: 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.
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.
- Conditions
- Stroke
- Being tested
- Creative therapy (art and music therapy), Physical therapy
- Keywords
- stroke, Art therapy, Music therapy, Creative therapy, Efficacy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creative therapy (art and music therapy)Other
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 therapyOther
Physical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week).
| Study group | Role | What they receive |
|---|---|---|
| Creative therapy | Experimental | Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks Receives: Other: Creative therapy (art and music therapy) |
| Control | Active comparator | Conventional physical therapy (5 times/week) for 4 weeks Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abbreviated Mental Score test (AMS)
The creative therapy will be considered success if the AMS increases after 4-week of treatment.
Measured: 4 weeks
Secondary outcomes (3)
Barthel index (BI)
The creative therapy will be considered success if the BI score increases after 4-week of treatment.
Measured: 4 weeks
Hospital anxiety depression score (HADS)
The creative therapy will be considered success if the HADS decreases after 4-week of treatment.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vilai Kuptniratsaikul, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455155
- Sponsor's protocol ID
- Si290/2011
- Status last verified
- Oct 2011
- First submitted
- 15 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Creative Therapy for Stroke Patients
- ClinicalTrials.gov ID
- NCT01455155
- Acronym / sponsor ID
- Si290/2011
- Conditions
- Stroke
- Keywords
- stroke, Art therapy, Music therapy, Creative therapy, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 19 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Creative therapy | Experimental | Other: Creative therapy (art and music therapy)Conventional physical therapy program (5 times/week) plus creative therapy (Art and Music) 2 times/week for 4 weeks |
| Control | Active comparator | Other: Physical therapyConventional physical therapy (5 times/week) for 4 weeks |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stroke patients
- Duration of stroke >=1 month
- Age >=50 years
- Ability to follow command and communicable
Key exclusion criteria (3 listed)
- Unstable medical conditions, including fever, uncontrolled hypertension
- Serious contact diseases, for example AIDS, TB
- Severe dementia or uncontrolled psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Creative therapy |
| Physical therapyPhysical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week). | Other | Control |
Primary outcome
Abbreviated Mental Score test (AMS)
Time frame: 4 weeks
The creative therapy will be considered success if the AMS increases after 4-week of treatment.
3 secondary outcomes
Barthel index (BI)
Time frame: 4 weeks
Hospital anxiety depression score (HADS)
Time frame: 4 weeks
Pictorial Thai Quality of Life score
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
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Metformin in Acute Ischemic Stroke
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Music Therapy in Post-Stroke Patients: A Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vilai Kuptniratsaikul, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Creative therapy (art and music therapy) and Physical therapy in people with Stroke, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vilai Kuptniratsaikul, MD (662-419-7511, sivkp@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbreviated Mental Score test (AMS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2011.