Comparison of Body Weight Support-Assisted Balance and Gait Training With or Without Balance Perturbations in Poststroke Rehabilitation: Multisite Randomized Controlled Trial.

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: This study aimed to evaluate the impact of a ceiling-track-mounted BWSS plus an integrated 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 2-to-6 BWSS or BWSS-P study sessions. Both groups conducted the same balance and gait regimen, with the BWSS-P group also receiving 8 balance perturbations per session. BBS, Activities-Specific Balance Confidence, and 10 Meter Walk Test assessments were collected. Results: A total of 126 patients were approached with 99 yielding sufficient data for analysis. With a corrected α level of .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 Activities-Specific Balance Confidence scale (F1,94.99=0.36; P=.55), or 10 Meter Walk Test (F1,97=4.15; P=.04). Conclusions: Although significant between-group differences were not observed, participants in both groups demonstrated similar improvements from before to after 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.