Rehabilitation programme for post-stroke lateropulsion including exoskeleton-assisted training: rationale and single-case experimental design protocol

Introduction Lateropulsion is characterised by an impaired active body orientation with respect to gravity. After hemisphere stroke, it is caused by a biased internal model of verticality and affects up to two-thirds of individuals in the acute phase after the right lesion location. It substantially limits mobility, increases the risk of falls and slows functional recovery. Despite its high prevalence and major clinical impact, evidence supporting the effectiveness of rehabilitation programmes specifically targeting lateropulsion remains limited. The EXOskeleton LATeropulsion study aims to evaluate the effects of a structured rehabilitation programme specifically designed to treat lateropulsion by training verticality representation, body orientation relative to gravity, awareness of body orientation, fall prevention, postural stabilisation and spatial representation of body and near environment. Part of the intervention is delivered using exoskeleton-assisted training. Methods and analysis This monocentric study, conducted at the University Hospital Grenoble-Alpes (France), uses a single-case experimental design with a multiple-baseline approach. Three participants are enrolled sequentially, with prespecified baseline durations of non-specific rehabilitation of 1, 2 and 3 weeks according to inclusion order, followed by a 3-week lateropulsion-specific rehabilitation programme and a post-intervention period of non-specific rehabilitation (2–4 weeks). Intervention combines physiotherapy sessions and exoskeleton-assisted sessions using the Atalante device, both specifically targeting lateropulsion. It aims to modulate the internal model of verticality through implicit indexing of the upright position, achieved via exoskeleton-assisted exercises or body-weight-supported walking and by controlled body tilts. Exercises performed with or without the exoskeleton address awareness of body tilt, active control of body orientation relative to gravity, spatial attention and postural stabilisation tasks. The primary outcome is visual vertical (VV) orientation, assessed daily throughout the study. Secondary outcomes include postural vertical, clinical measures of lateropulsion, balance and gait assessments and feasibility and acceptability assessments. Individual VV time series will undergo visual analysis, and changes in level and trend between baseline and intervention will be estimated using segmented longitudinal regression accounting for baseline trajectories. Effects will be reported in degrees with 95% CIs and complemented by a design-comparable between-case standardised mean difference. Post-intervention data will be analysed separately to assess persistence of changes. Ethics and dissemination The study is approved by an institutional review board at the national level (Comité de Protection des Personnes Ile de France X; 2024-A01586-41). All participants will provide written informed consent before enrolment. Findings will be submitted to peer-reviewed journals in rehabilitation, stroke or neuroscience. Trial registration number NCT07023770.