Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation

 

But you didn't ask or answer the most important question! 

Does this get them recovered enough to not need the orthosis? 

Horrendous research, I'd have you all fired! Survivors don't want compensation, they want RECOVERY!

Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation

• Rebecca Macaluso,
• Matt Giffhorn,
• Sara Prokup,
• Brice Cleland,
• Jusuk Lee,
• Bokman Lim,
• Minhyung Lee,
• Hwang-Jae Lee,
• Sangeetha Madhavan &
• Arun Jayaraman 

Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 127 (2024) Cite this article

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Abstract

Objective

The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., Korea, called the Gait Enhancing and Motivating System-Hip (GEMS-H), in assistance mode only with the poststroke population in an outpatient-rehabilitation setting.

Methods

Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6–8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation.

Results

By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device.

Conclusions

Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke.

Trial Registration

This study is registered with ClinicalTrials.gov (NCT04285060).

Introduction

Stroke is the leading cause of adult-onset disability in the United States. Up to 80% of stroke survivors experience considerable gait impairments, such as reduced walking speeds, reduced endurance, and asymmetrical walking patterns, resulting in limited capacity for community ambulation [1]. These mobility deficits are the result of a combination of numerous neuromuscular changes post stroke, including: reduced corticospinal drive and control [2], muscle atrophy and weakness [3], impaired balance and postural control [4], and abnormal muscle synergies [5].

The goal of post-stroke rehabilitation is to facilitate return to an individual’s highest level of function for employment and social and community participation [6]. The return of mobility and walking is a crucial part of this return to everyday function [7]. There is strong evidence that individuals who have had a stroke continue to recover years after the original neurological insult [8, 9]. Thus, continuing therapy as part of outpatient care or in home/community settings provides the opportunity for individuals with chronic stroke to continue to recover walking function. One group of technologies that shows promise in seamless integration with the outpatient and community settings are unconstrained, light-weight, modular, robotic exoskeletons. The use of these modular exoskeletons may allow intense gait training to be combined with activities of daily living. Furthermore, these robots can also target specific chronic impairments without sacrificing the functional task practice. However, there are a limited number of studies that investigate the impact of this technology on walking performance in the chronic stroke population in the outpatient, home, and/or community settings [10, 11]. More clinical studies are warranted to help provide evidence to guide this new generation of light-weight, modular robots to become part of everyday rehabilitation strategies.

The primary objective of this study was to analyze the safety and efficacy, as measured by clinical outcomes, daily step count, and corticomotor excitability, of using the Samsung Gait Enhancing and Motivating System-Hip (GEMS-H) in assistance mode with the poststroke population as part of an outpatient-rehabilitation program. The primary hypothesis was that subjects would demonstrate improved clinical outcomes, as well as higher daily step counts and increased corticomotor excitability, after completing 18 training sessions.