EMPATH protocol: Randomized, double-blind trial of an Engaging and Mobile Prism Adaptation Treatment for spatial neglect in Home and rehabilitation settings

BACKGROUND: Spatial neglect is a common attentional condition post-stroke linked to poor rehabilitation outcomes. Prism adaptation, though a promising intervention, is not yet widely used clinically due to various barriers to its implementation, including limited accessibility, the repetitive nature of the therapy, and the need for specialized equipment. This protocol aims to examine the effectiveness, feasibility, and acceptability of an engaging, mobile, computerized prism adaptation procedure (Peg-the-Mole) for treating spatial neglect in stroke inpatient and outpatient community settings. METHODS/DESIGN: The present study uses a longitudinal, double-blind, quasi-randomized, controlled design. Forty-two individuals with right-hemisphere stroke experiencing mild to severe symptoms of neglect will be randomized into two groups: Use of Peg-the-Mole with 15-degree rightward-deviating prism goggles (intervention) or use of Peg-the-Mole with 5-degree rightward-deviating prism goggles (active control). Participants will complete 10 treatment sessions over 2 weeks, engaging with the Peg-the-Mole procedure for 15 minutes daily. Blinded assessments will take place immediately before and after treatment, as well as at one-month follow-up. The primary outcome measure will be the Star Cancellation conventional subtest of the Behavioural Inattention Test. Secondary outcomes will include additional conventional and behavioural subtests of the Behavioural Inattention Test, one subtest of the Eschenbeck Standardized Activities of Daily Living battery, the caregiver- and self-reported forms of the Halifax Neglect Impact Scale, data measuring feasibility and acceptability, prism adaptation after-effects, the Hospital Anxiety and Depression Scale, and the Fatigue Severity Scale. DISCUSSION: The Peg-the-Mole procedure has the potential to improve patient recovery and quality of life after stroke due to its gamified, portable features that promote treatment accessibility and adherence. Results from this study will help determine if the treatment can be implemented successfully in inpatient and community settings to improve neglect symptoms and daily living. TRIAL REGISTRATION: Clinicaltrials.gov, Identifier: NCT05595668; registered October 27, 2022.