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
Sensory 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 (Walk...
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| Vydané v: | Frontiers in aging neuroscience Ročník 12; s. 592751 |
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| Hlavní autori: | , , , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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Switzerland
Frontiers Research Foundation
09.11.2020
Frontiers Media S.A |
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| ISSN: | 1663-4365, 1663-4365 |
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| Abstract | Sensory 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.
Participants 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.
Forty-five participants of 52 enrolled across four sites completed in-clinic assessments. FGA scores improved from 15.0 to 19.1 (
< 0.0001), normal and fast gait speed from 0.86 m/s to 0.95 m/s (
< 0.0001) and 1.24 m/s to 1.33 m/s (
= 0.002), respectively, and TUG from 13.8 s to 12.5 s (
= 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%,
= 0.01), whereas subjects with ABC scores above 67% showed a decrease (76.6% to 71.8%,
= 0.019). Subjects who reported falls in the prior 6 months (
= 25) showed a decrease in the number of fall-risk factors (5.1 to 4.3,
= 0.023) and a decrease in fall rate (13.8 to 7.4 falls/1000 days,
= 0.014). Four pre-study non-fallers (
= 20) fell during the 10 weeks.
A wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN.
ClinicalTrials.gov (#NCT03538756). |
|---|---|
| AbstractList | Sensory 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.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.Participants 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.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.Forty-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.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.A wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN.CONCLUSIONA wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN.ClinicalTrials.gov (#NCT03538756).TRIAL REGISTRATIONClinicalTrials.gov (#NCT03538756). Background: Sensory 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, USA) 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. Methods: Participants 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 Four-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. Results: Forty-five participants of 52 enrolled across four sites completed in-clinic assessments. FGA scores improved from 15.0 to 19.1 (p<0.000001), normal and fast gait speed from 0.86m/s to 0.95m/s (p<0.00005) and 1.24m/s to 1.33m/s (p<0.002), respectively, and TUG from 13.8s to 12.5s (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 six 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. Conclusion: A wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN. Trial registration: ClinicalTrials.gov (#NCT03538756) 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). Sensory 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. Participants 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. Forty-five participants of 52 enrolled across four sites completed in-clinic assessments. FGA scores improved from 15.0 to 19.1 ( < 0.0001), normal and fast gait speed from 0.86 m/s to 0.95 m/s ( < 0.0001) and 1.24 m/s to 1.33 m/s ( = 0.002), respectively, and TUG from 13.8 s to 12.5 s ( = 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%, = 0.01), whereas subjects with ABC scores above 67% showed a decrease (76.6% to 71.8%, = 0.019). Subjects who reported falls in the prior 6 months ( = 25) showed a decrease in the number of fall-risk factors (5.1 to 4.3, = 0.023) and a decrease in fall rate (13.8 to 7.4 falls/1000 days, = 0.014). Four pre-study non-fallers ( = 20) fell during the 10 weeks. A wearable sensory prosthesis presents a new way to treat gait and balance problems and manage falls in high fall-risk patients with PN. ClinicalTrials.gov (#NCT03538756). |
| Author | Oddsson, Lars I. E. Manor, Brad Bisson, Teresa Koehler-McNicholas, Sara R. Khoshnoodi, Mohammad Jacobs, Laura Kung, Doris Lipsitz, Lewis A. Cohen, Helen S. McCracken, Patricia Wrisley, Diane M. Rumsey, Yvonne |
| AuthorAffiliation | 7 Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife , Roslindale, MA , United States 1 RxFunction Inc. , Eden Prairie, MN , United States 9 Harvard Medical School , Boston, MA , United States 10 Minneapolis VA Health Care System , Minneapolis, MN , United States 11 College of Saint Mary , Omaha, NE , United States 4 M Health Fairview , Minneapolis, MN , United States 3 Recaniti School for Community Health Professions, Ben Gurion University of the Negev , Beersheba , Israel 5 Baylor College of Medicine , Houston, TX , United States 2 Department of Rehabilitation Medicine, University of Minnesota , Minneapolis, MN , United States 6 The Johns Hopkins University School of Medicine , Baltimore, MD , United States 8 Division of Gerontology, Beth Israel Deaconess Medical Center , Boston, MA , United States |
| AuthorAffiliation_xml | – name: 8 Division of Gerontology, Beth Israel Deaconess Medical Center , Boston, MA , United States – name: 10 Minneapolis VA Health Care System , Minneapolis, MN , United States – name: 6 The Johns Hopkins University School of Medicine , Baltimore, MD , United States – name: 4 M Health Fairview , Minneapolis, MN , United States – name: 5 Baylor College of Medicine , Houston, TX , United States – name: 2 Department of Rehabilitation Medicine, University of Minnesota , Minneapolis, MN , United States – name: 7 Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife , Roslindale, MA , United States – name: 11 College of Saint Mary , Omaha, NE , United States – name: 1 RxFunction Inc. , Eden Prairie, MN , United States – name: 3 Recaniti School for Community Health Professions, Ben Gurion University of the Negev , Beersheba , Israel – name: 9 Harvard Medical School , Boston, MA , United States |
| Author_xml | – sequence: 1 givenname: Lars I. E. surname: Oddsson fullname: Oddsson, Lars I. E. – sequence: 2 givenname: Teresa surname: Bisson fullname: Bisson, Teresa – sequence: 3 givenname: Helen S. surname: Cohen fullname: Cohen, Helen S. – sequence: 4 givenname: Laura surname: Jacobs fullname: Jacobs, Laura – sequence: 5 givenname: Mohammad surname: Khoshnoodi fullname: Khoshnoodi, Mohammad – sequence: 6 givenname: Doris surname: Kung fullname: Kung, Doris – sequence: 7 givenname: Lewis A. surname: Lipsitz fullname: Lipsitz, Lewis A. – sequence: 8 givenname: Brad surname: Manor fullname: Manor, Brad – sequence: 9 givenname: Patricia surname: McCracken fullname: McCracken, Patricia – sequence: 10 givenname: Yvonne surname: Rumsey fullname: Rumsey, Yvonne – sequence: 11 givenname: Diane M. surname: Wrisley fullname: Wrisley, Diane M. – sequence: 12 givenname: Sara R. surname: Koehler-McNicholas fullname: Koehler-McNicholas, Sara R. |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33240077$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Copyright © 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas. 2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Copyright © 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas. 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas |
| Copyright_xml | – notice: Copyright © 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas. – notice: 2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: Copyright © 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas. 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas |
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| DOI | 10.3389/fnagi.2020.592751 |
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| Keywords | gait speed neuromodulation sensory prosthesis falls balance neuroprosthesis peripheral neuropathy sensory substitution |
| Language | English |
| License | Copyright © 2020 Oddsson, Bisson, Cohen, Jacobs, Khoshnoodi, Kung, Lipsitz, Manor, McCracken, Rumsey, Wrisley and Koehler-McNicholas. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 content type line 23 Reviewed by: Alexander Stamenkovic, Virginia Commonwealth University, United States; Francesco Maria Petrini, SensArs Neuroprosthetics, Switzerland Edited by: Federico Ranieri, University of Verona, Italy |
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| PublicationTitle | Frontiers in aging neuroscience |
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| Snippet | Sensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of long-term,... Background: Sensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of... BackgroundSensory peripheral neuropathy (PN) is associated with gait, balance problems and high fall risk. The walk2Wellness trial investigates effects of... |
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| SubjectTerms | Activities of daily living Ankle Balance Diabetes Exercise Falls Gait gait speed Health risks Hypotheses Injuries neuromodulation neuroprosthesis Neuroscience Older people Peripheral neuropathy Prostheses Quality of life R&D Research & development Risk factors Tactile stimuli Vestibular system Walking |
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| Title | 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 |
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