A therapeutic shoe engineered to improve stroke recovery is proving successful and expected to hit the market by the end of the year. Clinical trials have been completed on the U.S. patented and licensed iStride Device, formerly the Gait Enhancing Mobile Shoe (GEMS), with results just published  in the Journal of NeuroEngineering and Rehabilitation. September 16, 2019
by Sarah Worth, University of South Florida-Tampa December 13, 2017
A new device created at the University of South Florida – and including a cross-disciplinary team of experts from USF engineering, physical therapy and neurology – is showing early promise for helping correct the signature limp experienced by many stroke survivors.
Called the Gait Enhancing Mobile Shoe (GEMS), the shoe attachment is the result of multidisciplinary work and expertise in USF’s engineering, physical therapy, and neurology programs.
In addition to offering stroke patients good outcomes for improving their gait and balance, a preliminary study is showing the shoe also provides several advantages over a current stroke rehabilitation tool – the split-belt treadmill – including lower cost, greater convenience, and mobility.
“This is early in the process but we’re seeing the benefits we expected so it’s very promising,” said Kyle Reed PhD, associate professor in the Department of Mechanical Engineering in the USF College of Engineering and principal investigator for the preliminary study on GEMS.
“We really want to help people who are limited in their walking ability to improve enough so they can return to the activities of their daily lives. The long-term hope is that this shoe attachment could be less expensive and safe enough that, once trained on how to use it, patients could take the GEMS home for therapy.”
Reed developed the GEMS shoe along with Seok Hun Kim PT PhD, associate professor in the School of Physical Therapy and Rehabilitation Sciences in the USF Health Morsani College of Medicine and co-principal investigator for the GEMS study. In 2010, Dr. Reed received funding from the National Institutes of Health to conduct a clinical trial  of a small group of stroke survivors trying the GEMS; the study is not for severe stroke survivors, but mild to moderate stroke survivors.
The study  also includes USF Health stroke expert David Z. Rose MD, associate professor in the Department of Neurology in the USF Health Morsani College of Medicine, who said he sees the GEMS as a great potential option for stroke patients to improve their mobility.
“Many stroke patients are devastated that their ability to walk on their own can be so limited, even around their own homes,” Dr. Rose said. “Early data for the GEMS is very promising and the next phases of study will really help us see its true potential.”
Many stroke patients develop an asymmetric gait because of damage to their central nervous system, resulting in difficulty moving their affected leg – they can’t extend their foot backward enough, which prevents natural pushing off into the swing phase experienced in an unaffected walk.
Typical stroke rehabilitation to improve gait symmetry involves using a split-belt treadmill that offers two independent belts operating at different speeds to exaggerate the asymmetry of the patient’s gait.
But an odd yet natural thing happens when patients leave the treadmill – their brain returns to a fixed-floor state and they regress, with many finding it difficult to recreate the gait correction on solid ground, a regression that is called an after effect.
While generally successful for improving stroke patients’ gaits, the split-belt treadmill is expensive, requires a dedicated space to house and a qualified staff to monitor sessions and, because of after effect, can require more time for patients to master the correction, said Seok Hun Kim PT PhD, associate professor in the School of Physical Therapy and Rehabilitation Sciences in the USF Health Morsani College of Medicine.
“The GEMS allows movement across any safe surface, thus ‘rewiring’ the brain to learn the new compensation technique for everyday walking, not just for when they are on the treadmill,” Dr. Kim said.
“The GEMS is generally worn on the unaffected side, helping the patient use their affected side to compensate for the irregular footing.”
While early results of this preliminary study are showing strong support for a successful approach to improving the gait of stroke patients, more detailed study with more patients will be necessary. Dr. Kim said a full study, one that compares to the current approach with the split-belt treadmill, is critical before clinicians adjust their approach.
|USF Engineer improves gait for stroke patients. iStride developer, Kyle Reed, demonstrates a prototype of the device back in 2017. USF Health. Youtube Dec 13, 2017. Sandra C. Roa, USF Communications|
|The iStride™ Gait Solution. Moterum Technologies Inc. Youtube Mar 27, 2019|
Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study, Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x. Full text
Gait enhancing mobile shoe (GEMS) for rehabilitation, Allison de Groot, Ryan Decker, Kyle B. Reed. World Haptics 2009 – Third Joint EuroHaptics Conference and Symposium on Haptic Interfaces for Virtual Environment and Teleoperator Systems, 18-20 March 2009, Salt Lake City UT, USA
iStride(TM) Device Used for Stroke Rehabilitation, Kyle B Reed, PhD. University of South Florida Tampa, Moterum Technologies Inc. ClinicalTrials.gov Identifier: NCT02185404
Device for Improving Double Limb Support, Step Length Symmetry, and Gait Speed in Hemiparetic Patients, Seok Hun Kim, David Huizenga, Ismet Handz̆ić, Rebecca Edgeworth, Matthew Lazinski, Tyagi Ramakrishnan, David Rose, Kyle Reed. October 2017. Archives of Physical Medicine and Rehabilitation, Volume 98, Issue 10, e52. doi: 10.1016/j.apmr.2017.08.158
Initial results of the gait enhancing mobile shoe on individuals with stroke, Seok Hun Kim, Ismet Handz̆ić, David Huizenga, Rebecca Edgeworth, Matthew Lazinski, Tyagi Ramakrishnan, Kyle B Reed. 2016. Proceedings of the International Conference of the IEEE Engineering in Medicine and Biology Society EMBC ’16, Orlando FL, USA
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Comparison of the passive dynamics of walking on ground, tied-belt and split-belt treadmills, and via the Gait Enhancing Mobile Shoe (GEMS), Handz̆ić I, Reed KB. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650509. doi: 10.1109/ICORR.2013.6650509.
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Design and Pilot Study of a Gait Enhancing Mobile Shoe, Handz̆ić I, Barno EM, Vasudevan EV, Reed KB. Paladyn. 2011 Dec 1;2(4). doi: 10.2478/s13230-012-0010-7.
Motion Controlled Gait Enhancing Mobile Shoe for Rehabilitation, Ismet Handz̆ić, Erin V. Vasudevan, and Kyle B. Reed. IEEE Int Conf Rehabil Robot. 2011 June; 2011: 1–6. doi: 10.1109/ICORR.2011.5975417
Stroke Patients Relearning How to Walk with Peculiar Shoe University of South Florida
GEMS: the Gait Enhancing Mobile Shoe Rehabilitation Engineering and Electromechanical Design Lab, University of South Florida
New simulator integrates technologies for interdisciplinary research, rehabilitation University of South Florida