Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial
INTRODUCTION: Physical rehabilitation restores lost function and promotes brain plasticity in people with Multiple Sclerosis (MS). Research groups worldwide are testing the therapeutic effects of combining non-invasive neuromodulation with physical therapy (PT) to further improve functional outcomes...
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Online Access: | https://digitalcommons.wustl.edu/oa_4/2463 https://doi.org/10.1016/j.cct.2023.107142 https://digitalcommons.wustl.edu/context/oa_4/article/3469/viewcontent/1_s2.0_S1551714423000654_main.pdf |
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ftwashingtonusm:oai:digitalcommons.wustl.edu:oa_4-3469 2023-12-10T09:50:56+01:00 Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial Ploughman, Michelle Melam, Ganeswara Rao Buragadda, Syamala Lohse, Keith R Clift, Fraser Stefanelli, Mark Levin, Michael Donkers, Sarah J 2023-04-01T07:00:00Z application/pdf https://digitalcommons.wustl.edu/oa_4/2463 https://doi.org/10.1016/j.cct.2023.107142 https://digitalcommons.wustl.edu/context/oa_4/article/3469/viewcontent/1_s2.0_S1551714423000654_main.pdf unknown Digital Commons@Becker https://digitalcommons.wustl.edu/oa_4/2463 doi:10.1016/j.cct.2023.107142 https://digitalcommons.wustl.edu/context/oa_4/article/3469/viewcontent/1_s2.0_S1551714423000654_main.pdf 2020-Current year OA Pubs Humans Multiple Sclerosis Quality of Life Neoplasm Recurrence Local Walking Physical Therapy Modalities Exercise Therapy Randomized Controlled Trials as Topic ICTS (Institute of Clinical and Translational Sciences) Medicine and Health Sciences text 2023 ftwashingtonusm https://doi.org/10.1016/j.cct.2023.107142 2023-11-12T17:41:06Z INTRODUCTION: Physical rehabilitation restores lost function and promotes brain plasticity in people with Multiple Sclerosis (MS). Research groups worldwide are testing the therapeutic effects of combining non-invasive neuromodulation with physical therapy (PT) to further improve functional outcomes in neurological disorders but with mixed results. Whether such devices enhance function is not clear. We present the rationale and study design for a randomized controlled trial evaluating if there is additional benefit to the synergistic pairing of translingual neurostimulation (TLNS) with PT to improve walking and balance in MS. METHODS AND ANALYSIS: A parallel group [PT + TLNS or PT + Sham], quadruple-blinded, randomized controlled trial. Participants (N = 52) with gait and balance deficits due to relapsing-remitting or progressive MS, who are between 18 and 70 years of age, will be recruited through patient registries in Newfoundland & Labrador and Saskatchewan, Canada. All participants will receive 14 weeks of PT while wearing either a TLNS or sham device. Dynamic Gait Index is the primary outcome. Secondary outcomes include fast walking speed, subjective ratings of fatigue, MS impact, and quality of life. Outcomes are assessed at baseline (Pre), after 14 weeks of therapy (Post), and 26 weeks (Follow Up). We employ multiple methods to ensure treatment fidelity including activity and device use monitoring. Primary and secondary outcomes will be analyzed using linear mixed-effect models. We will control for baseline score and site to test the effects of Time (Post vs. Follow-Up), Group and the Group x Time interaction as fixed effects. A random intercept of participant will account for the repeated measures in the Time variable. Participants must complete the Post testing to be included in the analysis. ETHICS AND DISSEMINATION: The Human Research Ethics Boards in Newfoundland & Labrador (HREB#2021.085) & Saskatchewan (HREB Bio 2578) approved the protocol. Dissemination avenues include peer-reviewed ... Text Newfoundland Washington University School of Medicine: Digital Commons@Becker Canada Newfoundland Contemporary Clinical Trials 127 107142 |
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Washington University School of Medicine: Digital Commons@Becker |
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ftwashingtonusm |
language |
unknown |
topic |
Humans Multiple Sclerosis Quality of Life Neoplasm Recurrence Local Walking Physical Therapy Modalities Exercise Therapy Randomized Controlled Trials as Topic ICTS (Institute of Clinical and Translational Sciences) Medicine and Health Sciences |
spellingShingle |
Humans Multiple Sclerosis Quality of Life Neoplasm Recurrence Local Walking Physical Therapy Modalities Exercise Therapy Randomized Controlled Trials as Topic ICTS (Institute of Clinical and Translational Sciences) Medicine and Health Sciences Ploughman, Michelle Melam, Ganeswara Rao Buragadda, Syamala Lohse, Keith R Clift, Fraser Stefanelli, Mark Levin, Michael Donkers, Sarah J Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
topic_facet |
Humans Multiple Sclerosis Quality of Life Neoplasm Recurrence Local Walking Physical Therapy Modalities Exercise Therapy Randomized Controlled Trials as Topic ICTS (Institute of Clinical and Translational Sciences) Medicine and Health Sciences |
description |
INTRODUCTION: Physical rehabilitation restores lost function and promotes brain plasticity in people with Multiple Sclerosis (MS). Research groups worldwide are testing the therapeutic effects of combining non-invasive neuromodulation with physical therapy (PT) to further improve functional outcomes in neurological disorders but with mixed results. Whether such devices enhance function is not clear. We present the rationale and study design for a randomized controlled trial evaluating if there is additional benefit to the synergistic pairing of translingual neurostimulation (TLNS) with PT to improve walking and balance in MS. METHODS AND ANALYSIS: A parallel group [PT + TLNS or PT + Sham], quadruple-blinded, randomized controlled trial. Participants (N = 52) with gait and balance deficits due to relapsing-remitting or progressive MS, who are between 18 and 70 years of age, will be recruited through patient registries in Newfoundland & Labrador and Saskatchewan, Canada. All participants will receive 14 weeks of PT while wearing either a TLNS or sham device. Dynamic Gait Index is the primary outcome. Secondary outcomes include fast walking speed, subjective ratings of fatigue, MS impact, and quality of life. Outcomes are assessed at baseline (Pre), after 14 weeks of therapy (Post), and 26 weeks (Follow Up). We employ multiple methods to ensure treatment fidelity including activity and device use monitoring. Primary and secondary outcomes will be analyzed using linear mixed-effect models. We will control for baseline score and site to test the effects of Time (Post vs. Follow-Up), Group and the Group x Time interaction as fixed effects. A random intercept of participant will account for the repeated measures in the Time variable. Participants must complete the Post testing to be included in the analysis. ETHICS AND DISSEMINATION: The Human Research Ethics Boards in Newfoundland & Labrador (HREB#2021.085) & Saskatchewan (HREB Bio 2578) approved the protocol. Dissemination avenues include peer-reviewed ... |
format |
Text |
author |
Ploughman, Michelle Melam, Ganeswara Rao Buragadda, Syamala Lohse, Keith R Clift, Fraser Stefanelli, Mark Levin, Michael Donkers, Sarah J |
author_facet |
Ploughman, Michelle Melam, Ganeswara Rao Buragadda, Syamala Lohse, Keith R Clift, Fraser Stefanelli, Mark Levin, Michael Donkers, Sarah J |
author_sort |
Ploughman, Michelle |
title |
Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
title_short |
Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
title_full |
Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
title_fullStr |
Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
title_full_unstemmed |
Translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (NeuroMSTraLS): Study protocol for a randomized controlled trial |
title_sort |
translingual neurostimulation combined with physical therapy to improve walking and balance in multiple sclerosis (neuromstrals): study protocol for a randomized controlled trial |
publisher |
Digital Commons@Becker |
publishDate |
2023 |
url |
https://digitalcommons.wustl.edu/oa_4/2463 https://doi.org/10.1016/j.cct.2023.107142 https://digitalcommons.wustl.edu/context/oa_4/article/3469/viewcontent/1_s2.0_S1551714423000654_main.pdf |
geographic |
Canada Newfoundland |
geographic_facet |
Canada Newfoundland |
genre |
Newfoundland |
genre_facet |
Newfoundland |
op_source |
2020-Current year OA Pubs |
op_relation |
https://digitalcommons.wustl.edu/oa_4/2463 doi:10.1016/j.cct.2023.107142 https://digitalcommons.wustl.edu/context/oa_4/article/3469/viewcontent/1_s2.0_S1551714423000654_main.pdf |
op_doi |
https://doi.org/10.1016/j.cct.2023.107142 |
container_title |
Contemporary Clinical Trials |
container_volume |
127 |
container_start_page |
107142 |
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1784896245946384384 |