Stroke Clinical Trial
Official title:
Can an Arts Based Creative Engagement Intervention Following Stroke Improve Psychosocial Outcomes? A Feasibility Trial of a Creative Engagement Intervention for In-patient Rehabilitation
Title: A C E S Study: Can an arts based creative engagement intervention (CEI) following
stroke improve psychosocial outcomes? A feasibility trial of a creative engagement
intervention for inpatient rehabilitation.
This is a feasibility randomised controlled trial of a novel intervention for stroke
rehabilitation examining effects of participation in visual arts activities on psychosocial
outcomes after stroke.
The investigators hypothesise that participation in a visual arts based intervention (CEI)
will improve stroke recovery variables, mood and self-esteem in stroke survivors receiving
in-patient rehabilitation compared to viewing a portfolio of artwork.
The results of the study will inform a sample size calculation for a full trial.
SUMMARY
Background: Stroke is the main cause of complex adult disability in Britain. Stroke
rehabilitation is typically task orientated, focusing on physical and functional
independence. Psychosocial consequences of stroke are serious and mediate recovery,
influencing family relationships, community reintegration and quality of life. Therefore,
improving psychosocial outcomes after stroke could improve overall recovery.
Creative arts programmes are increasingly used to address psychosocial outcomes in long-term
and mental health conditions. These programmes focus on positive influences of engagement in
creative art activities facilitated by artists. However, there is little research into
effects of creative engagement on psychosocial outcomes after stroke.
Objectives: The purpose of this study is to:
Conduct a feasibility randomised controlled trial (RCT) to test the effects of a
participatory visual arts intervention compared to art viewing on psychosocial outcomes
following stroke in order to assess effect size for sample size calculation in a full RCT.
The effects of the CEI will be examined in a randomised controlled feasibility trial, which
will be run at two stroke rehabilitation units in NHS Tayside and will explore the impact of
the intervention on a range of psychosocial outcomes.
Patients meeting inclusion criteria will be randomised to a CEI group or an attention control
group. The CEI group will receive a visual arts intervention of 4-8 sessions during
in-patient rehabilitation. The control group will receive an art portfolio to view after
randomisation and baseline assessment, with information about community opportunities to
engage in art. The groups will be compared on selected psychosocial outcomes. Findings will
indicate the potential magnitude and direction of change to allow for sample size
requirements in development of a subsequent randomised control trial to examine effectiveness
of the CEI.
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