Category: Stroke; Technology (e.g. robotics, assistive technology, mHealth)
Objective : To investigate the clinical efficacy and safety of a home use gait treatment device for the improvement of post-stroke gait impairments.
Before-after trial where each individual’s gait was compared before and 1 week after the treatment period.
Setting : The participants' home.
Participants (or Animals, Specimens, Cadavers) :
Subjects were recruited via volunteer sample with 21 subjects completing the training protocol and analyzed for primary and secondary endpoints. Eligibility criteria included: age 21-80, one or more cerebral stroke (on same side), last stroke occurred at least 6 months ago, and gait asymmetry but able to walk independently with or without a cane.
Twelve sessions ambulating on the iStrideTM device for 30 mins (three times per week for four weeks). Sessions were supervised by a physical therapist.
Main Outcome Measure(s) :
Primary Outcome: gait speed 10 Meter Walk Test (10MWT) and secondary outcome measures included: Timed Up and Go Test (TUG), Berg Balance Scale (BBS), Functional Gait Assessment (FGA), and Stroke Specific Quality of Life Scale (SS-QOL).
Results showed statistically significant improvement, above minimal detectable change (MDC), from baseline to 1-week post-training (p=0.0001 for 10MWT, p=0.0001 for TUG, p=0.001 for BBS, p=0001 for FGA, and p=0.001 for SS-QOL). 100% of subjects improved beyond the MDC on at least 1 metric, 76% improved beyond the MDC on 3/4 metrics. 62% of our subjects improved at least 1 gait speed category and 90% reduced fall risk on at least 1 metric.
The iStrideTM device, used in the home environment, facilitates clinically significant improvements in gait speed and fall risk for individuals with hemiparesis from stroke.
Lauren Rashford– Director of Clinical Operations and Customer Development, Moterum Technologies Inc., Charlotte, North Carolina
Brianne Darcy– Clinical Research Manager, Moterum Technologies, Charlotte, North Carolina
Elizabeth Lundin– Clinical Trial Physical Therapist, Moterum Technologies Inc., Katy, Texas
Ryan Medas– Physical Therapist, Moterum, Charoltte, North Carolina
Stephen Shultz– Assistant Professor, Wingate University, Matthews, North Carolina
Elizabeth DuBose– Manager of Therapies, Prisma Heath- Roger C Peace Rehabilitation Hospital, Greenville, South Carolina
David Huizenga– CEO, Moterum Technologies, Seneca, South Carolina
Kyle Reed– Associate Professor of Mechanical Engineering, University of South Florida, Tampa, Florida