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Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes : study protocol for a single blind randomized controlled trial : the ACES study . BACKGROUND Benefits of art participation after stroke are becoming increasingly recognized . Qualitative studies suggest that participation in visual arts creative engagement interventions ( CEIs ) during rehabilitation after stroke may improve mood , self-esteem , hope and some aspects of physical recovery . This study examines the feasibility of undertaking a randomized controlled trial of a CEI delivered by artists within in-patient stroke rehabilitation to test effectiveness . METHODS/DESIGN This trial is a two arm , single-blind , randomized controlled feasibility trial within in-patient stroke rehabilitation . We will recruit 80 patients receiving stroke rehabilitation in two stroke units in a health board area of Scotland ( 40 patients in each arm ) . Intervention arm participants will receive a visual-arts based CEI facilitated by experienced artists . Artists will follow an intervention protocol with specific components that enable participants to set , achieve and review artistic goals . Participants will receive up to eight intervention sessions , four within a group and four one-to-one with the artist . Control group participants will receive usual care only.Data collection will occur at baseline , post-intervention and three-month follow-up . Stroke-related health status is the primary outcome ; mood , self-esteem , self-efficacy , perceived recovery control and hope are secondary outcomes . Semi-structured interviews will be conducted with purposively selected patients , artists and healthcare staff to elicit views and experiences of the intervention and feasibility and acceptability of trial processes . Recruitment rates , retention rates and patient preference for art participation will also be collected . Data will indicate , with confidence intervals , the proportion of patients choosing or refusing participation in the CEI and will allow calculation of recruitment rates for a future definitive trial . Summary data will indicate potential variability , magnitude and direction of difference between groups . Findings will inform sample size calculations for a definitive trial . Thematic analysis of qualitative data will be managed using the Framework Approach . Framework is an analytical approach for qualitative data , commonly used in policy and medical research . DISCUSSION If shown to demonstrate effects , this intervention has the potential to address aspects of stroke recovery previously . Not routinely addressed in rehabilitation . TRIAL REGISTRATION Registered with Clinical Trials.Gov : NCT02085226 on 6th March 2014 .
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Intervention_Physical
stroke rehabilitation
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Intervention_Educational
visual-arts based CEI
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Intervention_Psychological
facilitated by experienced artists
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Outcome_Other
effects
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Outcome_Mental
psychosocial outcomes :
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Outcome_Mental
mood , self-esteem , hope
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Outcome_Physical
Stroke-related health status
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Outcome_Mental
mood , self-esteem , self-efficacy , perceived recovery control and hope are secondary
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Outcome_Other
feasibility and acceptability
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Outcome_Mental
Recruitment rates , retention rates and patient preference for art participation
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Outcome_Mental
recruitment rates
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Participant_Sample-size
80 patients
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Participant_Condition
stroke
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Participant_Sample-size
40