Clinical trial NCT03729648: Expressive Arts-based Intervention for Young and Pre-elderly Stroke Survivors
Official title: The Psycho-physiological & Social-spiritual Effects of Expressive Arts-based Intervention on Young and Pre-elderly Stroke Survivors: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Younger Stroke survivors
Expressive Arts Therapy
Rehabilitation
Randomized Controlled Trial
Salivary Cortisol
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group.

Detailed description: Stroke is a devastating illness that induces numerous impairments of body function and structure, and limitations to activities in all aspects of life, thus imposing multi-faceted restrictions on one's participation in daily living. It also has detrimental impacts on one's mental health, social relationship, and quality of life. Stroke survivors often face challenges arising from the illness and its disabilities, as well as the resulting deterioration of occupational functioning. They also suffer from the psycho-spiritual sequels of loss in functioning, sense of worthlessness and hopelessness, and fear of relapse, all of which could result in mental health distress such as depression, anxiety, stress, isolation, and impaired quality of life. Though the risk of stroke increases with age, statistics have documented an increasing trend of a younger age of onset. The issues faced by younger and pre-elderly stroke survivors (\<65 years old) will be even more severe due to longer term of survival, problems of resuming their occupations, and lacking of social welfare and resources for their pre-elderly age.

Existing research focuses primarily on older adults stroke survivors; this study is set out to contribute to current knowledge of the effectiveness of arts-based rehabilitation on younger stroke survivors. Both psychological and physiological outcomes will be examined for a comprehensive understanding on the biological, psychological, social, and spiritual changes after participating in a non-pharmacological, engaging, safe and enjoyable multi-modal expressive arts-based intervention approach of rehabilitation.

Examination on the relationships among bio-psycho-social-spiritual variables may help understand the complex relationships among these factors after stroke and during rehabilitation, which will contribute to the development of holistic care for stroke survivors.

This current study will adopt a 2-arm randomized controlled design with treatment-as-usual control. Upon screening for inclusion exclusion criteria, baseline data will be collected; and eligible participants will be randomized into either an 8-week Expressive Arts-based intervention group or Treatment-As-Usual control group. The control group will continue with routine rehabilitation service and have the option to participate in the Expressive Arts-based Intervention Group upon study completion. Participants will be assessed 3 times at baseline (T0), post-intervention (8th week, T1), and 6-month post-intervention (T2). The participants will complete the study in about 8 months.

Eligibility criteria: Inclusion Criteria:

1. Presence of a single-lesion stroke in the left or right, temporal, frontal, parietal or subcortical brain region
2. Experienced a major stroke event within 120 months from the time of study participation
3. Diagnosis of either (a) ischemic or (b) hemorrhagic stroke
4. Disability grade 1 to 4 on the Modified Rankin Scale
5. With residual functions of the affected extremity
6. The ability to understand instructions, both verbal and written in Chinese, and;
7. Ages 18 to below 65

Exclusion Criteria:

1. Concurrent diagnosis of major medical or psychiatric disorders other than stroke (except depression)
2. Currently receiving hospital treatment and care
3. Presence of hearing or visual deficits, even with aids
4. Total paralysis of the upper limbs
5. Amputation of one of the limbs

Primary outcomes:
measure: Change from Baseline Depression and Anxiety level at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Perceived Stress level at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Perceived Social Support level at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Self-esteem at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Hope level at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Spiritual well-being level at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Stroke-specific quality of life at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline general quality of life at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
measure: Change of Baseline Physical stress level and cortisol rhythm at 2 months and 8 months
timeFrame: Baseline, Month 2, and Month 8
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre on Behavioral Health HKU
Study officials:
affiliation: Director/Professor
name: Rainbow Ho
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan CKP, Lo TLT, Wan AHY, Leung PPY, Pang MYC, Ho RTH. A randomised controlled trial of expressive arts-based intervention for young stroke survivors. BMC Complement Med Ther. 2021 Jan 6;21(1):7. doi: 10.1186/s12906-020-03161-6.