Gait Device Treatment Using Telehealth for Individuals With Stroke During the COVID-19 Pandemic: Nonrandomized Pilot Feasibility Study.

BACKGROUND: During the COVID-19 pandemic, rehabilitation providers and consumers adopted telehealth practices at unprecedented rates. Multiple prepandemic studies demonstrate the feasibility and comparable efficacy between in-clinic and remote treatment for certain impairments caused by stroke, such as upper extremity weakness and impaired motor function. However, less guidance has been available regarding gait assessment and treatment. Despite this limitation, safe and effective gait treatment is fundamental to optimizing health and well-being after stroke and should be considered a treatment priority, including during the COVID-19 pandemic. OBJECTIVE: This study explores the feasibility of using telehealth to deliver gait treatment using a wearable gait device, the iStride device, to stroke survivors during the 2020 pandemic. The gait device is used to treat hemiparetic gait impairments caused by stroke. The device alters the user's gait mechanics and creates a subtle destabilization of the nonparetic limb; therefore, supervision is required during its usage. Before the pandemic, treatment with the gait device had been provided in person to appropriate candidates using a combination of physical therapists and trained personnel. However, upon the emergence of the COVID-19 pandemic, in-person treatment was halted in adherence to pandemic guidelines. This study investigates the feasibility of 2 remote delivery treatment models with the gait device for stroke survivors. METHODS: Participants were recruited during the first half of 2020 after the onset of the pandemic and included 5 individuals with chronic stroke (mean age 72 years; 84 months post stroke). Four participants were previous gait device users who transitioned to the telehealth delivery model to continue their gait treatment remotely. The fifth participant performed all study-related activities, from recruitment through follow-up, remotely. The protocol included virtual training for the at-home care partner, followed by 3 months of remote treatment with the gait device. Participants were instructed to wear gait sensors during all treatment activities. To assess feasibility, we monitored the safety of the remote treatment, compliance with protocol activities, acceptability of the telehealth treatment delivery, and preliminary efficacy of the gait treatment. Functional improvement was measured using the 10-Meter Walk Test, the Timed Up and Go Test, and the 6-Minute Walk Test, and quality of life was assessed using the Stroke-Specific Quality of Life Scale. RESULTS: No serious adverse events occurred, and participants rated high acceptance of the telehealth delivery. Protocol compliance averaged 95% of treatment sessions, 100% of assessments, and 85% of sensor usage during treatment. After 3 months of treatment, the average improvement in each functional outcome exceeded the minimal clinically important difference or minimal detectable change value. CONCLUSIONS: Remote treatment delivery with the gait device appeared feasible with care partner support. Gait treatment using telehealth may be useful to offset negative immobility impacts for those requiring or preferring remote care during the pandemic or otherwise. TRIAL REGISTRATION: ClinicalTrials.gov NCT04434313; https://clinicaltrials.gov/ct2/show/NCT04434313.

One-year retention of gait speed improvement in stroke survivors after treatment with a wearable home-use gait device.

Background: Gait impairments after stroke are associated with numerous physical and psychological consequences. Treatment with the iStride® gait device has been shown to facilitate improvements to gait function, including gait speed, for chronic stroke survivors with hemiparesis. This study examines the long-term gait speed changes up to 12 months after treatment with the gait device. Methods: Eighteen individuals at least one-year post-stroke completed a target of 12, 30-minute treatment sessions with the gait device in their home environment. Gait speed was measured at baseline and five follow-up sessions after the treatment period: one week, one month, three months, six months, and 12 months. Gait speed changes were analyzed using repeated-measures ANOVA from baseline to each follow-up time frame. Additional analysis included comparison to the minimal clinically important difference (MCID), evaluation of gait speed classification changes, and review of subjective questionnaires. Results: Participants retained an average gait speed improvement >0.21 m/s compared to baseline at all post-treatment time frames. Additionally, 94% of participants improved their gait speed beyond the MCID during one or more post-treatment measurements, and 88% subjectively reported a gait speed improvement. Conclusion: Treatment with the gait device may result in meaningful, long-term gait speed improvement for chronic stroke survivors with hemiparetic gait impairments. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03649217, identifier NCT03649217.