Accepted for/Published in: JMIR Formative Research
Date Submitted: Oct 8, 2024
Date Accepted: May 8, 2025
Balance Improvement and Fall Risk Reduction in Stroke Survivors After Treatment with a Wearable Home-Use Gait Device: Single Group Long-Term Study
ABSTRACT
Background:
Falls are a common and serious problem after stroke, with devastating impacts on health and safety. Our previous research showed that functional balance, a primary risk factor for falls, improved immediately after four weeks of treatment with the iStride gait device. Understanding the long-term retention of these effects may 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 12, 30-minute treatment sessions with the gait device in their homes. Functional balance was assessed using the Berg Balance Scale (BBS), the Timed Up and Go (TUG) test, and the Functional Gait Assessment (FGA) at baseline and five post-treatment follow-ups: one week, one month, three months, six months, and twelve months after treatment. Balance improvement was analyzed using repeated-measures ANOVA from baseline to each follow-up time frame, correlation analysis, comparison to the minimal detectable change (MDC), evaluation of fall risk classification changes, and subjective questionnaires.
Results:
Participants retained statistically significant improvements on the BBS, TUG, and FGA compared to baseline at all post-treatment time frames, P<.05. Additionally, 100% of participants reduced their risk for falls on at least one outcome; over 44% of participants exceeded the MDC of all outcomes at each post-treatment time period, and 88% of participants subjectively observed functional balance improvement.
Conclusions:
Findings indicate that treatment with the gait device may result in long-term functional balance improvement for individuals with hemiparetic gait impairments from stroke. Clinical Trial: ClinicalTrials.gov Identifier: NCT03649217
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