One session of prism adaptation training does not increase immediate engagement in occupational therapy in people with spatial neglect early after stroke: a proof-of-concept study nested within a phase II RCT

Objectives Spatial neglect, a debilitating cognitive syndrome and predictor of poor functional outcome, affects attention and awareness after stroke. Early rehabilitation is essential but neglect itself may impede participation in therapy. In a proof-of-concept study nested within an RCT, we investigated whether the oft-reported immediate effects of prism adaptation training (PAT) might enable engagement if introduced at the start of an occupational therapy session. Methods Early after stroke we video-recorded in-patients carrying out a standardised activity in their first RCT occupational therapy session, before and after PAT (or a control therapy activity). Level of engagement was later scored by a video-rater, experienced in therapy, blind to arm allocation (intervention/control) and whether randomly presented videos were recorded pre-or post-therapy. The rater recorded engagement scores on a 100mm visual analogue scale. Treating therapists also reported, on a 3-point Likert scale, whether or not engagement changed. Results 49 of the RCT’s 53 patients were recruited (37 PAT, 12 control), 43 of whom consented to be video-recorded. Regression analysis did not suggest improvement in engagement following one session of PAT, using the blinded expert video scoring method: mean difference (95% CI) = −0.5 (−7.4 to 6.4) mm; p =0.89). Similarly, post-hoc re-rating of engagement scores (the video-rater viewed paired pre- and post-therapy recordings but remained blind to arm allocation) excluded any material difference in engagement following PAT: mean difference (95% CI) = 1.2 (−2.5 to 4.9) mm; p =.52). Impressions of level of engagement provided by the treating occupational therapists also suggested no change: OR (95% CI) = 1.3 (0.13 to 13); p =0.81). Conclusions Despite the need to enable neglect patients to engage in the therapy they are offered, we are confident that a single session of PAT at the start of a therapy session does not enhance immediate engagement in occupational therapy early after stroke. Our study does not address the alternative definition of engagement as a longitudinal, rapport-building process which could meaningfully be explored. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN88395268 ### Funding Statement This independent research was funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0816-20016). This research also received funding from The University of Manchester Research Impact Scholarship (MC) and Stroke Association, UK (AB; grant number TSA LECT 2015/01; SCOPE: Strategies to COPE with cognitive difficulties after stroke). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was approved by the Yorkshire and the Humber National Health Service Research Ethics Committee in the United Kingdom (18/YH/048) and entered on the ISRCTN registry, . I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.