Walkasins Clinical Trials & Research | Sensory Peripheral Neuropathy

Providing balance to people
with peripheral neuropathy

Initial In-Clinic Research Showing Meaningful Improvements in Balance and Gait Function Published in PLOS ONE Journal in 2019

In collaboration with the Minneapolis VA Medical Center, outcomes with Walkasins in this study showed:

Improved Balance

Functional Gait Assessment (FGA) score improved by an average of 4.4. points.

Improved Gait Speed

Mean normal gait speed increased from 0.93 m/s to 1.02 m/s

Decreased Fall-Risk

A majority of subjects no longer classified at high-risk for falls (FGA>22)

Positive results from the PLOS ONE in-clinic study of short-term effects of Walkasins led to study of long-term effects of Walkasins use.

Walkasins Clinical Trials | Functional Gait Assessment Improvements

In-clinic assessment of Walkasins in randomized cross-over design demonstrating improvements when device turned on.

PLOS ONE

Long-Term Safety & Effectiveness

Ongoing multi-site U.S. Clinical Trial to Investigate Long-Term, Daily Effects of Walkasins Use on Gait, Balance Function, and Patient-Reported Outcomes:

Walk2Wellness

VISIT TRIAL SITE

walk2Wellness Study Design

Randomized cross-over study
Outcome measures:

Functional Gait Assessment (FGA)
Walking Speed
4-stage Balance Test
Timed-Up-and-Go (TUG)

Walkasins Sensory Neuroprosthesis | walk2Wellness Clinical Study Design

The Functional Gait Assessment (FGA) is the preferred metric for gait balance and can predict future falls. It has been shown to be low in individuals with peripheral neuropathy^7,8.

A history of falls has been linked to reduced confidence with mobility, decreased activity levels, ultimately contributing to decreased quality of life⁹.

Gait speed typically declines with age and it declines faster in those with peripheral neuropathy^10,11.

Slower gait speed is related to increased disability, hospitalization, mortality, need for fall prevention interventions and reduced access to the community¹².

walk2Wellness INTERIM Study Overview and Update

walk2Wellness Interim Results Have Been Presented At:

American Physical Therapy Association (APTA) Combined Sections Meeting
International Society of Physical and Rehabilitation Medicine (ISPM&R)
American Academy of Neurology (AAN)
Peripheral Nerve Society (PNS)

SEE MORE CONFERENCE PRESENTATIONS

walk2Wellness Clinical Partners Include:

Teresa Bisson, PT, DPT, NCS, ATP, University of Minnesota – M Health Fairview, St. Paul, Minnesota
Helen Cohen, EdD, OTR, FAOTA, Baylor College of Medicine, Houston, Texas
Mohammad Khoshnoodi, MD, Johns Hopkins School of Medicine, Baltimore, Maryland
Lewis A. Lipsitz, MD, Director, Hinda and Arthur Marcus Institute for Aging Research, Chief Academic Officer, Irving and Edyth S. Usen and Family Chair in Medical Research, Professor of Medicine, Harvard Medical School, Chief, Division of Gerontology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
Sara Koehler-McNicholas, PhD, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota
Doris Kung, D.O., Baylor College of Medicine, Houston, Texas
Brad Manor, Ph.D., Associate Scientist, Marcus Institute, and Assistant Professor of Medicine, Harvard Medical School, Boston, Massachusetts
Diane Wrisley, PT, PhD, NCS, College of St. Mary, Omaha, Nebraska

Established Clinical Utility for Sensory Replacement

Walkasins System | Wearable Sensory Prosthetic | RxFunction

Tactile stimuli have been shown to enhance balance function and reaction time compared to other forms of sensory stimuli^13,14,15,16.

Walkasins is a sensory neuroprosthesis designed to utilize tactile stimuli to improve balance.

EXPLORE CONFERENCE PRESENTATIONS ON WALKASINS

EXPLORE PEER-REVIEWED RESEARCH

Sensory Peripheral Neuropathy and Walkasins

Sensory information from plantar cutaneous mechanoreceptors, important for postural control and balance, is lost as a result of peripheral neuropathy.⁴

Epidemiological evidence has linked patients with peripheral neuropathy to:

Increased risk of falling¹
Decreased stability while standing²
Reduced stability when exposed to balance perturbations³

Sensory Peripheral Neuropathy | Walking & Balance

Walkasins Sensory Neuroprosthesis Unit

Walkasins sensory neuroprosthesis can improve gait and balance function in patients with peripheral neuropathy who have balance impairments.⁵

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References

Richardson JK, Hurvitz EA. Peripheral neuropathy: A true risk factor for falls. J Gerontol A Biol Sci Med Sci. 1995; 50(4): M211–215. pmid:7614243
Geurts AC, Mulder TW, Nienhuis B, Mars P, Rijken RA. Postural organization in patients with hereditary motor and sensory neuropathy. Arch Phys Med Rehabil. 1992; 73(6): 569–572. pmid:1622307
Inglis JT, Horak FB, Shupert CL, Jones-Rycewicz C. The importance of somatosensory information in triggering and scaling automatic postural responses in humans. Exp Brain Res. 1994; 101(1): 159–164. pmid:7843295
Meyer PF, Oddsson LI, De Luca CJ. The role of plantar cutaneous sensation in unperturbed stance. Exp Brain Res. 2004b Jun;156(4):505-12. Epub 2004 Feb 14
Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE (2019) Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet – A randomized control cross-over study. PLoS ONE 14(4): e0216212. https://doi.org/10.1371/journal.pone.0216212
https://link.springer.com/article/10.1007/s00221-004-1868-3 https://link.springer.com/search?query=oddsson+meyer&search-within=Journal&facet-journal-id=221
Diane M. Wrisley, Neeraj A. Kumar, Functional Gait Assessment: Concurrent, Discriminative, and Predictive Validity in Community-Dwelling Older Adults, Physical Therapy, Volume 90, Issue 5, 1 May 2010, Pages 761–773, https:// doi.org/10.2522/ptj.20090069
Koehler-McNicholas SR, Danzl L, Cataldo AY, Oddsson LIE (2019) Neuromodulation to improve gait and balance function using a sensory neuroprosthesis in people who report insensate feet – A randomized control cross-over study. PLoS ONE 14(4): e0216212. https://doi.org/10.1371/journal.pone.0216212
Dionyssiotis Y. (). Analyzing the problem of falls among older people. International journal of general medicine, 5, 805–813. doi:10.2147/IJGM.S32651
Studenski, S. (2011). Gait Speed and Survival in Older Adults. Jama, 305(1), 50. doi:10.1001/jama.2010.1923
Lipsitz, L. A., Manor, B., Habtemariam, D., Iloputaife, I., Zhou, J., & Travison, T. G. (2018). The pace and prognosis of peripheral sensory loss in advanced age: association with gait speed and falls. BMC geriatrics, 18(1), 274. doi:10.1186/ s12877-018-0970-5Gait speed is predictive of survival with slower gait speeds indicative of earlier mortality.
Middleton, A., Fritz, S. L., & Lusardi, M. (2015). Walking speed: the functional vital sign. Journal of aging and physical activity, 23(2), 314–322. doi:10.1123/japa.2013-0236
Meyer PF, Oddsson LI, De Luca CJ. The role of plantar cutaneous sensation in unperturbed stance. Exp Brain Res. 2004b Jun;156(4):505-12. Epub 2004 Feb 14
Jeka JJ. Light touch contact as a balance aid. Phys Ther. 1997;77(5):476–487. doi:10.1093/ptj/77.5.476
J. M. T. Brebner and A. T. Welford, “Introduction: an historical background sketch,” in Reaction Times, A. T. Welford, Ed., pp. 1–23, Academic Press, New York, NY, USA, 1980.
Jeka JJ. Light touch contact as a balance aid. Phys Ther. 1997;77(5):476–487. doi:10.1093/ptj/77.5.476
A. Moscatelli, M. Bianchi, S. Ciotti, G. C. Bettelani, C. V. Parise, F. Lacquaniti, A. Bicchi, Touch as an auxiliary proprioceptive cue for movement control. Sci. Adv. 5, eaaw3121 (2019).

Indication for Use

Walkasins is indicated for patients with lower limb sensory peripheral neuropathy who present with gait and balance impairments. Walkasins is indicated for patients who can feel the tactile stimuli from the Leg Unit on the lower leg.

Please see the Safety Information for a complete list of warnings, precautions, and contraindications.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Healthcare Professionals

Providing balance to people
with peripheral neuropathy

Clinical Research

Clinically Proven Technology