Title: A feasibility Study of Prisms And Therapy In Attention Loss after stroke (SPATIAL feasibility)
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Half of the UK s 1M stroke survivors experience disability. National guidelines recommend occupational therapy (OT) to increase independence but people with Unilateral Spatial Neglect , a cognitive impairment of attention/awareness of one side, have difficulty engaging in OT. INTERVENTION: Prism Adaptation Training only takes 10 minutes to: seat the patient, fit prism glasses and practise pointing to targets. The prisms shift the view to one side. With repeated pointing the person s awareness is adjusted. When the glasses are removed the brain is temporarily tricked to looking more to the neglected side. Adding Prism Adaptation Training to the beginning of OT sessions might enable people with neglect to engage in and benefit from recommended OT. AIMS: To test proof of concept of the prism intervention in the clinical setting, and determine the feasibility and acceptability of delivery of intervention and conducting a randomised controlled trial. RESEARCH QUESTION: Is it feasible to conduct a randomised controlled trial of prism adaptation training delivered within OT, up to five times per week for up to three weeks for people with unilateral spatial neglect after stroke in the post-acute setting? DESIGN: Mixed methods: a multi-centre, feasibility, stratified randomised controlled trial with process evaluation and proof of concept exploration with service user involvement. SETTING: Six North West NHS OT in-patient stroke services (and Early Supported Discharge services if appropriate). TRIAL PARTICIPANTS: Adults who screen positive for neglect that is causing difficulty with everyday activities, 1-4 weeks post admission with stroke, eligible for standard OT, normally residing in the area and able to provide consent/proxy, sit with support and perform brief intervention. Where available, adult informal carers will be invited to participate. RECRUITMENT: Sites will open to recruitment one per month for 12 months maximum. Monthly recruitment is estimated at 1 to 1.5 per site suggesting a total sample of 60-80. Consenting participants with neglect will be randomly allocated in a 3:1 ratio to either prism adaptation training and OT or OT without prism adaptation training using a concealed, online randomisation service stratified by site. The researcher collecting follow-up outcome measures will be blind to group allocation. Participants will be asked to nominate an informal carer who will be invited to provide their perspective. An estimated 40-50 carers will take part. PROOF OF CONCEPT: We will video the first OT session to examine the immediate effect of prism training on engagement in OT. Videos will be analysed by a blinded rater. PARTICIPANT OUTCOMES: will be measured at intervention end (T1) and three months post -randomisation (T2). The intended primary outcome for a definitive trial is Extended Activities of Daily Living at T2. Secondary outcomes include standardised neglect tests; a patient reported measure of impact of cognitive difficulties, length of stay, destination on transfer from in-patient care. We will measure impact on carers and self-reported informal carer costs. PROCESS EVALUATION: Telephone interviews with OTs will include their experiences; treatment fidelity; implementation; acceptability and delivery across the stroke pathway. After outcome assessment researchers will ask participants with stroke and informal carers about acceptability of intervention delivery and trial processes. FEASIBILITY OUTCOMES: We will measure recruitment, treatment fidelity, acceptability, attrition, completeness of data collection and variability for this population in the proposed primary outcome. POTENTIAL BENEFITS: Presence of neglect in the early weeks is associated with poor long term outcomes. People with neglect miss out on the full benefits of evidence-based early stroke care and are often transferred from in-patient care with considerable care packages. Their cognitive difficulties exclude them from much stroke research. This study aims to remove these barriers.

Lay abstract: Stroke is a sudden interruption of the blood supply to the brain caused by a clot or a bleed. Half of the UK s one million stroke survivors experience disability and national guidelines recommend occupational therapy to increase independence in everyday activities. Some people have difficulty engaging in therapy because of Unilateral Spatial Neglect which impairs attention/awareness of one side e.g. of the body. Prism Adaptation Training only takes 10 minutes to: fit prism glasses and practise pointing to visual targets. The prisms shift the view to one side. With repeated pointing the person s awareness is adjusted. When the glasses are removed the brain is temporarily tricked to looking more to the neglected side. This adaptation might enable people to engage in and benefit from recommended occupational therapy. To find out whether adding prism adaptation training to occupational therapy is effective we need research (a clinical trial). Trials often overestimate the number of patient participants that can be recruited or fail for other reasons. To ensure success we propose an initial feasibility trial over two years at six stroke services. We will test methods of recruiting and following up participants. Of the 80 participants, 60 will have therapy with prism training and 20 without, decided at random. By videoing sessions we will examine whether prism training enables the patient to engage attention in therapy. We will explore whether therapists deliver the prism training as intended, 5 times a week for 3 weeks, and will interview occupational therapists about any difficulties they had. We will assess disability in the stroke survivors to determine how to measure the possible benefits and ask survivors and family carers for their views. Stroke survivors helped design this application and will advise throughout. The study s findings will be provided to participants. Amended 25/7/17 following panel review

Research activity codes: 6.7 PHYSICAL
Health categories: STROKE