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Completed

NCT Number: NCT02085226

Art as Creative Engagement for Stroke

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NHS (National Health Service) Tayside, Stroke Rehab Unit, Stracathro Hospital, Brechin, Angus, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Stroke
  • Medically stable and referred for rehabilitation
  • Able to sit upright in chair
  • 3 or more weeks of rehabilitation planned

Exclusion criteria

  • Diagnosis of Transient Ischemic Attack
  • Patinet in acute medical need
  • Patient unable to provide informed consent

Treatment and study plan

Creative Engagement Intervention

Other

The CEI has 5 component stages which map the participant's journey with the Artist

  • Meeting with Artist, discuss interests, stroke and explore initial creative goals.
  • Introduction to materials and mark making to create interpretations of established images.
  • From mark making and interpretations to developing personal project ideas.
  • Turning personal project ideas into creative finished pieces.
  • Review of completed work, mounting and display of work, future plans.

It is recognised that participants will progress differently. Components may be repeated or retuned to or may be addressed simultaneously. Participants may progress rapidly and so move from stage 5 back to stages 2, 3 or 4 to progress new work or experience new materials or processes.

Other names: CEI

Portfolio Group

Other

The Portfolio group will receive conventional rehabilitation activity at each site. In addition, to control for effects of art related attention received by the intervention group, after baseline assessment and randomisation, this group will receive from the research assistant, a portfolio of work produced by previous participants of the Tayside CEI, with details of community programmes that people with stroke can attend after hospital discharge. Participants will be invited to view the portfolio during their stay. Prior to outcome assessment, the research assistant will visit participants again to answer questions and to discuss options for community programmes, if the person is interested.

Primary outcomes

  1. Stroke Impact Scale

    Time frame: Assessed at end of intervention at 4 weeks

Secondary outcomes

  1. Positive and Negative Affect Schedule (PANAS)

    Time frame: Assessed at end of intervention at 4 weeks

  2. Visual Analogue Self-Esteem Scale (VASES)

    Time frame: Assessed at end of intervention at 4 weeks

Other outcomes

  1. Trait Hope Scale

    Time frame: Assessed at end of intervention at 4 weeks

  2. General Self Efficacy Scale

    Time frame: Assessed at end of intervention at 4 weeks

  3. Self-Efficacy for Art Scale

    Time frame: Assessed at end of intervention at 4 weeks

  4. Recovery Locus Of Control Scale (RLOC)

    Time frame: Assessed at end of intervention at 4 weeks

  5. Stroke Impact Scale

    Time frame: 16 weeks

  6. Positive and Negative Affect Scale

    Time frame: 16 weeks

  7. Visual Analogue Self-Esteem Scale

    Time frame: 16 weeks

  8. Trait Hope Scale

    Time frame: 16 weeks

  9. General Self-Efficacy Scale

    Time frame: 16 weeks

  10. Self-Efficacy for Art Scale

    Time frame: 16 weeks

  11. Recovery Locus of Control Scale

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • University of Edinburgh
  • University of Stirling

Registry information

Official study 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

Acronym: ACES

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 12, 2014
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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