Creative Therapy to Affect Stroke Outcomes

NCT ID: NCT01455155

Last Updated: 2011-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-05-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Creative therapy

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

Group Type: EXPERIMENTAL

Creative therapy (art and music therapy)

Intervention Type: 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.

Control

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

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vilai Kuptniratsaikul, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Countries

Thailand

Central Contacts

Vilai Kuptniratsaikul, MD

Role: CONTACT

sivkp@mahidol.ac.th

662-419-7511

Facility Contacts

Vilai Kuptniratsaikul, MD

Role: primary

sivkp@mahidol.ac.th

662-419-7511

Other Identifiers

Si290/2011

Identifier Type: -

Identifier Source: org_study_id