Comparison of body-weight support-assisted balance and gait training with or without balance perturbations in post-stroke rehabilitation: A multisite randomized controlled trial (Preprint)

BACKGROUND Impaired balance regulation after stroke puts patients and therapists at a heightened risk of injury during rehabilitation. Body weight support systems (BWSS) allow patients to safely conduct gait and balance training while minimizing risk and the fear of falling. Integrating perturbation-based balance training (PBT) modules with a BWSS may lead to further improvements. OBJECTIVE Our goal was to evaluate the impact of a ceiling-track mounted BWSS integrated with a novel PBT (BWSS-P) module on the rehabilitation of stroke-related gait and balance impairments. METHODS A multisite randomized active-comparator controlled trial was conducted. Inpatients with Berg Balance Scale (BBS) scores ≥21/56 were recruited from 4 sites. Participants completed two-to-six BWSS or BWSS-P study sessions. Both groups conducted the same balance and gait regimen, with the BWSS-P group also receiving eight balance perturbations per session. BBS, Activities-Specific Balance Confidence (ABC), and 10 Meter Walk Test (10MWT) assessments were collected. RESULTS 126 patients were approached with 99 yielding sufficient data for analysis. With a corrected alpha level of α=.0054, both groups showed significant in-group changes over time for all outcomes evaluated (P≤.001). However, the primary outcome measure, the BBS, did not show evidence of a difference between BWSS and BWSS-P groups over time (F1,97=1.57, P=0.21) via linear mixed-effects modeling with type III Wald F test with Kenward-Roger degrees of freedom. No significant between-group differences were noted for either secondary outcome measure, the ABC scale (F1,94.99=0.36, P=.55), or 10MWT (F1,97=4.15, P=.04). CONCLUSIONS Although significant between-group differences were not observed, participants in both groups demonstrated similar improvements from pre- to post-assessment. This novel PBT technology shows promise as an option for gait and balance recovery training, especially for individuals with impaired balance control or fear of falling. The BWSS-P intervention contributed positively to rehabilitation outcome overall and should be considered as a viable treatment modality when clinically appropriate. CLINICALTRIAL ClinicalTrials.gov (NCT05110300); https://clinicaltrials.gov/study/NCT05110300.