Real-world use of transcutaneous spinal neuromodulation combined with activity-based rehabilitation across neurological disorders: a retrospective post-market study

Background Transcutaneous spinal neuromodulation (TSN) is the first therapy approved by US FDA and is delivered in conjunction with activity-based rehabilitation, but evidence describing routine clinical use across heterogeneous neurological populations remains limited. Objective To characterize the real-world implementation and documented safety of TSN delivered via xStep-assisted rehabilitation and to describe within-participant changes in routinely collected clinical outcomes. Methods This retrospective observational study reviewed de-identified records from 50 individuals with cerebral palsy (CP; n = 29), spinal cord injury (SCI; n = 11), or other neurological or structural conditions ( n = 10). xStep was incorporated into individualized activity-based rehabilitation for approximately 1 h per session, 2–5 days per week. Outcomes available in routine records included hand-held dynamometry, Modified Ashworth Scale (MAS), International Standards for Neurological Classification of Spinal Cord Injury motor and sensory scores, 10-Meter Walk Test (10MWT), and Timed Up and Go (TUG) test. Analyses were descriptive; outcome-specific denominators are reported. Results During same-session dynamometry, mean force increased from 5.41 N without stimulation to 6.00 N with stimulation across 12 participants; 10 of 12 had a net increase in mean force. Spasticity decreased in at least one assessed muscle group in 13 of 24 participants. Among eight participants with SCI and paired assessments, mean motor score changed from 44.12 to 45.50 and mean sensory score from 124.62 to 129.12. Descriptive improvements were also observed in gait speed and TUG completion time among ambulatory participants, with variable assessment intervals and no untreated comparator. No device-related adverse event, serious adverse event, neurological deterioration, or device-related treatment discontinuation was documented in the reviewed records. Conclusions xStep was integrated into individualized neurorehabilitation without documented device-related adverse events or treatment discontinuations in this retrospective cohort. The observed within-participant changes are clinical signals and do not establish efficacy or causality. Diagnosis-specific prospective studies with standardized exposure, predefined endpoints, and comparator conditions are needed.