Creative Therapy to Affect Stroke Outcomes

NCT01455155 | Unknown Phase 4

• 1 other identifier: Si290/2011
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; Art therapy; Music therapy; Creative therapy; Efficacy

Outcome Measures

Primary Outcomes (1)

• Abbreviated Mental Score test (AMS)

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

  4 weeks

Secondary Outcomes (3)

• Barthel index (BI)

  4 weeks

• Hospital anxiety depression score (HADS)

  4 weeks

• Pictorial Thai Quality of Life score

  4 weeks

Study Arms (2)

Creative therapy

EXPERIMENTAL

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)

Control

ACTIVE COMPARATOR

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

Other: Physical therapy

Interventions

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.

Creative therapy

Physical therapy OTHER

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

Control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Stroke

Interventions

Reproductive Techniques, Assisted; Music Therapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics; Investigative Techniques; Sensory Art Therapies; Complementary Therapies; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Vilai Kuptniratsaikul, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vilai Kuptniratsaikul, MD

CONTACT

662-419-7511; sivkp@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

TH (1)