Safety and Efficacy: The Impact of Robotic Hip Exoskeleton on Outpatient Stroke Rehabilitation

Background

Stroke is the leading cause of disability among adults in the United States, with up to 80% of stroke survivors experiencing gait impairments, such as reduced walking speed, endurance, and asymmetrical gait, thereby limiting their ability to walk within their communities. These mobility deficits stem from a combination of various neuromuscular changes post-stroke, including reduced corticospinal conduction and control, muscle atrophy and weakness, impaired balance and postural control, and abnormal muscle synergies. The goal of post-stroke rehabilitation is to facilitate individuals in regaining the highest level of function for employment, socialization, and community participation. Restoring walking and mobility capabilities is a key part of returning to daily life.

In recent years, lightweight, modular robotic hip exoskeletons have gradually shown potential for seamless integration in outpatient and community settings, allowing intensive gait training to be combined with activities of daily living. Additionally, these robots can be used to specifically train for chronic injuries without sacrificing the practice of functional tasks. However, research on the impact of this new generation of lightweight, modular robots on walking performance in chronic stroke populations in outpatient, home, and/or community settings is scarce. Therefore, more clinical research is urgently needed to provide guidance and make these robots a part of daily rehabilitation strategies.

Study Source

This study was conducted by Rebecca Macaluso and others in 2024 and published in the Journal of Neuroengineering and Rehabilitation. The affiliations include Shirley Ryan AbilityLab among other institutions. The corresponding author is Arun Jayaraman, email: ajayaraman@sralab.org. For article details, see: Macaluso et al. Journal of Neuroengineering and Rehabilitation (2024) 21:127.

Aims and Methods

The study aimed to analyze the safety and efficacy of the Gait Enhancing and Motivation System-Hip (GEMS-H) developed by Samsung Electronics Limited, and evaluate its impact as an adjunct in the outpatient rehabilitation environment after stroke.

41 participants with an average age of 60 years and an average stroke onset of 6.5 years were recruited to complete a prospective, single-arm intervention longitudinal study during the COVID-19 pandemic. Significant modifications were made to the traditional outpatient clinical environment guided by the Centers for Disease Control and Prevention guidelines, with all participants receiving 18 training sessions over 6-8 weeks. An ankle-worn pedometer was used to collect daily step counts throughout the study period. Additionally, transcranial magnetic stimulation tested corticospinal excitability of four bilateral lower limb muscles at baseline and after training.

Main Results

At the end of training, the main outcome of walking speed increased by 0.13 meters/second. Walking endurance, balance, and functional gait also improved, such as a 47-meter increase in the 6-minute walking test, a 2.93-point improvement in the Berg Balance Scale, and a 1.80-point increase in the Functional Gait Assessment. Daily step count increased significantly, with an average increase of 1750 steps per day. Training detected a 35% increase in lower limb motor-evoked potentials and a significant reduction in the active motion threshold in the medial gastrocnemius muscle (decrease by 5.7 points).

Conclusion

Gait training using the GEMS-H hip exoskeleton significantly improved walking speed, walking endurance, and balance in chronic stroke patients. Daily activities also improved, as evidenced by the increase in daily step counts. Changes in cortical motor excitability indicate that training with this device may help correct the interhemispheric imbalance commonly seen after stroke.

Highlights

• Key finding: Gait training using the GEMS-H hip exoskeleton showed significant improvements in walking speed, endurance, and balance, as well as improvement in daily activities through increased daily step counts.
• Innovation in research method: Application of Samsung’s advanced hip exoskeleton for safe and effective gait training in outpatient settings.
• Specificity of the subject group: Focus on the stroke patient population, especially those in the chronic phase of stroke rehabilitation.

Other Valuable Information

This trial was registered at clinicaltrials.gov (NCT04285060). The study provides third level evidence that 18 sessions of 45-minute GEMS-H gait training can lead to significant improvements in walking speed, walking endurance, and balance for people with subacute and chronic stroke.

This paper culminated in an assessment of the safety and efficacy of gait training using the GEMS-H hip exoskeleton for stroke patients, demonstrating that GEMS-H is an effective tool for outpatient stroke rehabilitation, with significant implications for advancing gait rehabilitation and enhancing quality of life.