The Effects of a Wearable Sensory Prosthesis on Gait and Balance Function After 10 Weeks of Use in Persons With Peripheral Neuropathy and High Fall Risk - The walk2Wellness Trial
| Autor: | Lars I. E. Oddsson, Teresa Bisson, Helen S. Cohen, Laura Jacobs, Mohammad Khoshnoodi, Doris Kung, Lewis A. Lipsitz, Brad Manor, Patricia McCracken, Yvonne Rumsey, Diane M. Wrisley, Sara R. Koehler-McNicholas |
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| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
neuroprosthesis Aging medicine.medical_specialty Activities of daily living peripheral neuropathy Cognitive Neuroscience lcsh:RC321-571 03 medical and health sciences 0302 clinical medicine Physical medicine and rehabilitation Quality of life falls medicine lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry Balance (ability) sensory prosthesis business.industry balance sensory substitution medicine.disease Gait Clinical Trial 030104 developmental biology medicine.anatomical_structure Peripheral neuropathy Gait analysis neuromodulation Ankle medicine.symptom business gait speed 030217 neurology & neurosurgery Balance problems Neuroscience |
| Zdroj: | Frontiers in Aging Neuroscience Frontiers in Aging Neuroscience, Vol 12 (2020) |
| ISSN: | 1663-4365 |
| Popis: | BackgroundSensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of long-term, home-based daily use of a wearable sensory prosthesis on gait function, balance, quality of life and fall rates in PN patients. The device (Walkasins®, RxFunction Inc., MN, United States) partially substitutes lost nerve function related to plantar sensation providing directional tactile cues reflecting plantar pressure measurements during standing and walking. We tested the null hypothesis that the Functional Gait Assessment (FGA) score would remain unchanged after 10 weeks of use.MethodsParticipants had PN with lost plantar sensation, gait and balance problems, an FGA score < 23 (high fall risk), and ability to sense tactile stimuli above the ankle. Clinical outcomes included FGA, Gait Speed, Timed Up&Go (TUG) and 4-Stage Balance Test. Patient-reported outcomes included Activities-Specific Balance Confidence (ABC) scale, Vestibular Disorders Activities of Daily Living Scale, PROMIS participation and satisfaction scores, pain rating, and falls. Evaluations were performed at baseline and after 2, 6, and 10 weeks. Subjects were not made aware of changes in outcomes. No additional balance interventions were allowed.ResultsForty-five participants of 52 enrolled across four sites completed in-clinic assessments. FGA scores improved from 15.0 to 19.1 (p < 0.0001), normal and fast gait speed from 0.86 m/s to 0.95 m/s (p < 0.0001) and 1.24 m/s to 1.33 m/s (p = 0.002), respectively, and TUG from 13.8 s to 12.5 s (p = 0.012). Four-Stage Balance Test did not improve. Several patient-reported outcomes were normal at baseline and remained largely unchanged. Interestingly, subjects with baseline ABC scores lower than 67% (high fall risk cut-off) increased their ABC scores (49.9% to 59.3%, p = 0.01), whereas subjects with ABC scores above 67% showed a decrease (76.6% to 71.8%, p = 0.019). Subjects who reported falls in the prior 6 months (n = 25) showed a decrease in the number of fall-risk factors (5.1 to 4.3, p = 0.023) and a decrease in fall rate (13.8 to 7.4 falls/1000 days, p = 0.014). Four pre-study non-fallers (n = 20) fell during the 10 weeks.ConclusionA wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN.Trial registrationClinicalTrials.gov (#NCT03538756). |
| Databáze: | OpenAIRE |
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