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

NCT ID: NCT03729648

Last Updated: 2023-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.

Study Groups

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Intervention

This arm of participants will be receiving Expressive Arts Therapy as intervention

Group Type EXPERIMENTAL

Expressive Arts Therapy

Intervention Type BEHAVIORAL

The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.

Control

This arm of participants will not receive any intervention and are allocated as a wait-list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Expressive Arts Therapy

The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rainbow Ho

Role: PRINCIPAL_INVESTIGATOR

Director/Professor

Locations

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Centre on Behavioral Health HKU

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 33407413 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17609417

Identifier Type: -

Identifier Source: org_study_id

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