A Wearable Proprioceptive Stabilizer (Equistasi®) for Rehabilitation of Postural Instability in Parkinson’s Disease: A Phase II Randomized Double-Blind, Double-Dummy, Controlled Study
Identifieur interne : 000B75 ( Main/Merge ); précédent : 000B74; suivant : 000B76A Wearable Proprioceptive Stabilizer (Equistasi®) for Rehabilitation of Postural Instability in Parkinson’s Disease: A Phase II Randomized Double-Blind, Double-Dummy, Controlled Study
Auteurs : Daniele Volpe [Italie] ; Maria Giulia Giantin [Italie] ; Alfonso Fasano [Canada]Source :
- PLoS ONE [ 1932-6203 ] ; 2014.
English descriptors
- KwdEn :
- MESH :
- complications : Parkinson Disease.
- diagnosis : Parkinson Disease.
- etiology : Sensation Disorders.
- therapy : Parkinson Disease, Sensation Disorders.
- Aged, Female, Humans, Male, Middle Aged, Physical Therapy Modalities, Postural Balance, Treatment Outcome.
Abstract
Muscle spindles endings are extremely sensitive to externally applied vibrations, and under such circumstances they convey proprioceptive inflows to the central nervous system that modulate the spinal reflexes excitability or the muscle responses elicited by postural perturbations. The aim of this pilot study is to test the feasibility and effectiveness of a balance training program in association with a wearable proprioceptive stabilizer (Equistasi) that emits focal mechanical vibrations in patients with PD.
Forty patients with PD were randomly divided in two groups wearing an active or inactive device. All the patients received a 2-month intensive program of balance training. Assessments were performed at baseline, after the rehabilitation period (T1), and two more months after (T2). Posturographic measures were used as primary endpoint; secondary measures of outcome included the number of falls and several clinical scales for balance and quality of life.
Both groups improved at the end of the rehabilitation period and we did not find significant between-group differences in any of the principal posturographic measures with the exception of higher sway area and limit of stability on the instrumental functional reach test during visual deprivation at T1 in the Equistasi group. As for the secondary outcome, we found an overall better outcome in patients enrolled in the Equistasi group: 1) significant improvement at T1 on Berg Balance Scale (+45.0%, p = .026), Activities-specific Balance Confidence (+83.7, p = .004), Falls Efficacy Scale (−33.3%, p = .026) and PDQ-39 (−48.8%, p = .004); 2) sustained improvement at T2 in terms of UPDRS-III, Berg Balance Scales, Time Up and Go and PDQ-39; 3) significant and sustained reduction of the falls rate.
This pilot trial shows that a physiotherapy program for training balance in association with focal mechanical vibration exerted by a wearable proprioceptive stabilizer might be superior than rehabilitation alone in improving patients’ balance.
EudraCT
Url:
DOI: 10.1371/journal.pone.0112065
PubMed: 25401967
PubMed Central: 4234681
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Raffaele Arcangelo Fatebenefratelli Hospital, Venice</wicri:regionArea><wicri:noRegion>Venice</wicri:noRegion></affiliation></author><author><name sortKey="Giantin, Maria Giulia" sort="Giantin, Maria Giulia" uniqKey="Giantin M" first="Maria Giulia" last="Giantin">Maria Giulia Giantin</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice</wicri:regionArea><wicri:noRegion>Venice</wicri:noRegion></affiliation></author><author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. 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Raffaele Arcangelo Fatebenefratelli Hospital, Venice, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice</wicri:regionArea><wicri:noRegion>Venice</wicri:noRegion></affiliation></author><author><name sortKey="Giantin, Maria Giulia" sort="Giantin, Maria Giulia" uniqKey="Giantin M" first="Maria Giulia" last="Giantin">Maria Giulia Giantin</name><affiliation wicri:level="1"><nlm:aff id="aff1"><addr-line>Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice, Italy</addr-line></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice</wicri:regionArea><wicri:noRegion>Venice</wicri:noRegion></affiliation></author><author><name sortKey="Fasano, Alfonso" sort="Fasano, Alfonso" uniqKey="Fasano A" first="Alfonso" last="Fasano">Alfonso Fasano</name><affiliation wicri:level="4"><nlm:aff id="aff2"><addr-line>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital and Division of Neurology, University of Toronto, Toronto, Ontario, Canada</addr-line></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Morton and Gloria Shulman Movement Disorders Clinic and the Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital and Division of Neurology, University of Toronto, Toronto, Ontario</wicri:regionArea><orgName type="university">Université de Toronto</orgName><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (complications)</term><term>Parkinson Disease (diagnosis)</term><term>Parkinson Disease (therapy)</term><term>Physical Therapy Modalities</term><term>Postural Balance</term><term>Sensation Disorders (etiology)</term><term>Sensation Disorders (therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Sensation Disorders</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Parkinson Disease</term><term>Sensation Disorders</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Physical Therapy Modalities</term><term>Postural Balance</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Muscle spindles endings are extremely sensitive to externally applied vibrations, and under such circumstances they convey proprioceptive inflows to the central nervous system that modulate the spinal reflexes excitability or the muscle responses elicited by postural perturbations. The aim of this pilot study is to test the feasibility and effectiveness of a balance training program in association with a wearable proprioceptive stabilizer (Equistasi) that emits focal mechanical vibrations in patients with PD.</p></sec><sec><title>Methods</title><p>Forty patients with PD were randomly divided in two groups wearing an active or inactive device. All the patients received a 2-month intensive program of balance training. Assessments were performed at baseline, after the rehabilitation period (T1), and two more months after (T2). Posturographic measures were used as primary endpoint; secondary measures of outcome included the number of falls and several clinical scales for balance and quality of life.</p></sec><sec><title>Results</title><p>Both groups improved at the end of the rehabilitation period and we did not find significant between-group differences in any of the principal posturographic measures with the exception of higher sway area and limit of stability on the instrumental functional reach test during visual deprivation at T1 in the Equistasi group. As for the secondary outcome, we found an overall better outcome in patients enrolled in the Equistasi group: 1) significant improvement at T1 on Berg Balance Scale (+45.0%, p = .026), Activities-specific Balance Confidence (+83.7, p = .004), Falls Efficacy Scale (−33.3%, p = .026) and PDQ-39 (−48.8%, p = .004); 2) sustained improvement at T2 in terms of UPDRS-III, Berg Balance Scales, Time Up and Go and PDQ-39; 3) significant and sustained reduction of the falls rate.</p></sec><sec><title>Conclusions</title><p>This pilot trial shows that a physiotherapy program for training balance in association with focal mechanical vibration exerted by a wearable proprioceptive stabilizer might be superior than rehabilitation alone in improving patients’ balance.</p></sec><sec><title>Trial Registration</title><p>EudraCT <ext-link ext-link-type="uri" xlink:href="https://eudract.ema.europa.eu/">2013-003020-36</ext-link> and ClinicalTrials.gov (<ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov/">number not assigned</ext-link>)</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Lamont, Rm" uniqKey="Lamont R">RM Lamont</name></author><author><name sortKey="Morris, Me" uniqKey="Morris M">ME Morris</name></author><author><name sortKey="Woollacott, Mh" uniqKey="Woollacott M">MH Woollacott</name></author><author><name sortKey="Brauer, Sg" uniqKey="Brauer S">SG Brauer</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Tan, D" uniqKey="Tan D">D Tan</name></author><author><name sortKey="Danoudis, M" uniqKey="Danoudis M">M Danoudis</name></author><author><name sortKey="Mcginley, J" uniqKey="Mcginley J">J McGinley</name></author><author><name sortKey="Morris, Me" uniqKey="Morris M">ME Morris</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Soh, Se" uniqKey="Soh S">SE Soh</name></author><author><name sortKey="Morris, Me" 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uniqKey="Grasso R">R Grasso</name></author><author><name sortKey="Lacquaniti, F" uniqKey="Lacquaniti F">F Lacquaniti</name></author></analytic></biblStruct></listBibl></div1></back></TEI></record>Pour manipuler ce document sous Unix (Dilib)
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