Abstract
BACKGROUND: Lower body positive pressure (LBPP) may provide a novel intervention for gait training in neurological conditions. Nonetheless, studies investigating the safety and feasibility of LBPP in patients with stroke are insufficient. OBJECTIVES: The purpose of this study was to evaluate the safety and feasibility of LBPP as a rehabilitation intervention for individuals with chronic stroke. METHODS: Individuals with chronic stroke were recruited from the community to participate in LBPP gait training three times a week for six weeks. The LBPP's safety and feasibility were documented throughout the study and at the end of six weeks. Safety and feasibility referred to the incidence of adverse events, complications, the participant and therapist satisfaction questionnaire, and the device limitation including but not limited to technical issues and physical constraints. In addition, blood pressure, pulse rate, and oxygen saturation were taken pre- and post-session. Dependent t-tests were used to analyze the difference between assessments. A Wilcoxon test was used to assess the ordinal data (Trial registration number NCT04767334). RESULTS: Nine individuals (one female, eight males) aged 57 ± 15.4 years were enrolled. All participants completed the intervention without adverse events. All participants reported positive scores from 4 (very satisfying) to 5 (extremely satisfying) in the safety and feasibility questionnaire. No significant differences were observed in blood pressure and oxygen saturation during the intervention sessions. However, significant increases were observed in heart rate from 82.6 ± 9.1 beats/min (pre-session) to 88.1 ± 6.8 beats/min (post-session) (p = 0.027). CONCLUSIONS: LBPP is a safe and feasible rehabilitation tool to use with individuals with chronic stroke.