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Expressive Arts-based Intervention for Young and Pre-elderly Stroke Survivors

The University of Hong Kong (HKU) logo

The University of Hong Kong (HKU)

Status

Completed

Conditions

Stroke

Treatments

Behavioral: Expressive Arts Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03729648
17609417

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

154 participants in 2 patient groups

Intervention
Experimental group
Description:
This arm of participants will be receiving Expressive Arts Therapy as intervention
Treatment:
Behavioral: Expressive Arts Therapy
Control
No Intervention group
Description:
This arm of participants will not receive any intervention and are allocated as a wait-list control group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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