Balance Improvement and Fall Risk Reduction in Stroke Survivors After Treatment With a Wearable Home-Use Gait Device: Single-Arm Longitudinal Study With 1-Year Follow-Up.

Background: Falls are a common and serious problem after stroke, often leading to injuries, loss of independence, and increased health care usage. Functional balance, a primary risk factor for falls, is frequently impaired in individuals with hemiparetic gait impairments. Previous research with the iStride gait device (Moterum Technologies, Inc) showed that functional balance improved immediately following 4 weeks of treatment. However, the long-term retention of these effects remains unknown and could improve the management of balance and mobility impairments after stroke. Objective: This study aimed to determine the long-term functional balance effects of treatment with the gait device for individuals with hemiparetic gait impairments from stroke. Methods: Eighteen individuals with chronic stroke (9 male, 9 female, mean age 57 years, and 60 months post stroke) participated in twelve 30-minute treatment sessions with the gait device. During each treatment session, the device was worn on the less affected lower extremity during overground ambulation in the participant's home. All treatment and assessments were overseen by licensed physical therapists. Functional balance was evaluated using the Berg Balance Scale (BBS), the Timed Up and Go (TUG) test, and the Functional Gait Assessment (FGA) at baseline and 5 posttreatment follow-ups: 1 week, 1 month, 3 months, 6 months, and 12 months after treatment. Balance improvement was analyzed using repeated-measures ANOVA from baseline to each follow-up time frame, correlation analysis, comparison to each outcome's minimal detectable change (MDC) value, evaluation of fall risk classification changes, and subjective questionnaires. Results: Participants retained statistically significant improvements on the BBS, TUG, and FGA compared with baseline at all posttreatment time frames (P<.05). All participants initially identified as being at risk for falls reduced their fall risk on at least one outcome during one or more follow-up assessments. At 12 months post treatment, the average improvement on all 3 outcomes remained above their respective MDC thresholds, demonstrated by a 5.9-point improvement on the BBS, a 4.9-second improvement on the TUG, and a 34.6% (3.8-point) improvement on the FGA. At least 72% of participants exceeded the MDC of BBS, at least 44% exceeded the MDC of TUG, and at least 66% exceeded the MDC of FGA at every posttreatment time point. Subjective questionnaire responses indicated that 88% of participants perceived functional balance improvement following treatment with the gait device. Conclusions: The findings of this study indicate that treatment with the gait device may result in long-term functional balance improvement for individuals with hemiparetic gait impairments from stroke. Larger, controlled studies are recommended to confirm these findings.