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Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial

BACKGROUND: Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson’s Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermo...

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Autores principales: Duncan, Ryan P., Van Dillen, Linda R., Garbutt, Jane M., Earhart, Gammon M., Perlmutter, Joel S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822622/
https://www.ncbi.nlm.nih.gov/pubmed/29484198
http://dx.doi.org/10.1186/s40814-018-0243-2
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author Duncan, Ryan P.
Van Dillen, Linda R.
Garbutt, Jane M.
Earhart, Gammon M.
Perlmutter, Joel S.
author_facet Duncan, Ryan P.
Van Dillen, Linda R.
Garbutt, Jane M.
Earhart, Gammon M.
Perlmutter, Joel S.
author_sort Duncan, Ryan P.
collection PubMed
description BACKGROUND: Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson’s Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. METHODS/DESIGN: Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. DISCUSSION: To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. TRIAL REGISTRATION: NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0243-2) contains supplementary material, which is available to authorized users.
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spelling pubmed-58226222018-02-26 Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial Duncan, Ryan P. Van Dillen, Linda R. Garbutt, Jane M. Earhart, Gammon M. Perlmutter, Joel S. Pilot Feasibility Stud Study Protocol BACKGROUND: Subthalamic nucleus deep brain stimulation (STN-DBS) reduces tremor, muscle stiffness, and bradykinesia in people with Parkinson’s Disease (PD). Walking speed, known to be reduced in PD, typically improves after surgery; however, other important aspects of gait may not improve. Furthermore, balance may worsen and falls may increase after STN-DBS. Thus, interventions to improve balance and gait could reduce morbidity and improve quality of life following STN-DBS. Physical therapy (PT) effectively improves balance and gait in people with PD, but studies on the effects of PT have not been extended to those treated with STN-DBS. As such, the efficacy, safety, and feasibility of PT in this population remain to be determined. The purpose of this pilot study is to address these unmet needs. We hypothesize that PT designed to target balance and gait impairment will be effective, safe, and feasible in this population. METHODS/DESIGN: Participants with PD treated with STN-DBS will be randomly assigned to either a PT or control group. Participants assigned to PT will complete an 8-week, twice-weekly PT program consisting of exercises designed to improve balance and gait. Control group participants will receive the current standard of care following STN-DBS, which does not include prescription of PT. The primary aim is to assess preliminary efficacy of PT on balance (Balance Evaluation Systems Test). A secondary aim is to assess efficacy of PT on gait (GAITRite instrumented walkway). Participants will be assessed OFF medication/OFF stimulation and ON medication/ON stimulation at baseline and at 8 and 12 weeks after baseline. Adverse events will be measured over the duration of the study, and adherence to PT will be measured to determine feasibility. DISCUSSION: To our knowledge, this will be the first study to explore the preliminary efficacy, safety, and feasibility of PT for individuals with PD with STN-DBS. If the study suggests potential efficacy, then this would justify larger trials to test effectiveness and safety of PT for those with PD with STN-DBS. TRIAL REGISTRATION: NCT03181282 (clinicaltrials.gov). Registered on 7 June 2017. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s40814-018-0243-2) contains supplementary material, which is available to authorized users. BioMed Central 2018-02-21 /pmc/articles/PMC5822622/ /pubmed/29484198 http://dx.doi.org/10.1186/s40814-018-0243-2 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Duncan, Ryan P.
Van Dillen, Linda R.
Garbutt, Jane M.
Earhart, Gammon M.
Perlmutter, Joel S.
Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title_full Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title_fullStr Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title_full_unstemmed Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title_short Physical therapy and deep brain stimulation in Parkinson’s Disease: protocol for a pilot randomized controlled trial
title_sort physical therapy and deep brain stimulation in parkinson’s disease: protocol for a pilot randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5822622/
https://www.ncbi.nlm.nih.gov/pubmed/29484198
http://dx.doi.org/10.1186/s40814-018-0243-2
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