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      A Wearable Proprioceptive Stabilizer (Equistasi®) for Rehabilitation of Postural Instability in Parkinson’s Disease: A Phase II Randomized Double-Blind, Double-Dummy, Controlled Study

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      PLoS ONE
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          Abstract

          Background

          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.

          Methods

          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.

          Results

          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.

          Conclusions

          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.

          Trial Registration

          EudraCT 2013-003020-36 and ClinicalTrials.gov ( number not assigned)

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          Most cited references56

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          Falls efficacy as a measure of fear of falling.

          We developed the Falls Efficacy Scale (FES), an instrument to measure fear of falling, based on the operational definition of this fear as "low perceived self-efficacy at avoiding falls during essential, nonhazardous activities of daily living." The reliability and validity of the FES were assessed in two samples of community-living elderly persons. The FES showed good test-retest reliability (Pearson's correlation 0.71). Subjects who reported avoiding activities because of fear of falling had higher FES scores, representing lower self-efficacy or confidence, than subjects not reporting fear of falling. The independent predictors of FES score were usual walking pace (a measure of physical ability), anxiety, and depression. The FES appears to be a reliable and valid method for measuring fear of falling. This instrument may be useful in assessing the independent contribution of fear of falling to functional decline among elderly people.
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            The Balance Scale: reliability assessment with elderly residents and patients with an acute stroke.

            The objective of this study was to assess the reliability of the Balance Scale. Subjects were chosen from a larger group of 113 elderly residents and 70 stroke patients participating in a psychometric study. Elderly residents were examined at baseline, and at 3, 6 and 9 months, and the stroke patients were evaluated at 2, 4, 6 and 12 weeks post onset. The Cronbach's alphas at each evaluation were greater than 0.83 and 0.97 for the elderly residents and stroke patients respectively, showing strong internal consistency. To assess inter-rater reliability, therapists treating 35 stroke patients were asked to administer the Balance Scale within 24 hours of the independent evaluator. Similarly, caregivers at the Residence were asked to test the elderly residents within one week of the independent evaluator. To assess intra-rater reliability, 18 residents and 6 stroke patients were assessed one week apart by the same rater. The agreement between raters was excellent (ICC = 0.98) as was the consistency within the same rater at two points in time (ICC = 0.97). The results support the use of the Balance Scale in these groups.
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              Bayesian decision theory in sensorimotor control.

              Action selection is a fundamental decision process for us, and depends on the state of both our body and the environment. Because signals in our sensory and motor systems are corrupted by variability or noise, the nervous system needs to estimate these states. To select an optimal action these state estimates need to be combined with knowledge of the potential costs or rewards of different action outcomes. We review recent studies that have investigated the mechanisms used by the nervous system to solve such estimation and decision problems, which show that human behaviour is close to that predicted by Bayesian Decision Theory. This theory defines optimal behaviour in a world characterized by uncertainty, and provides a coherent way of describing sensorimotor processes.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2014
                17 November 2014
                : 9
                : 11
                : e112065
                Affiliations
                [1 ]Department of Physical Medicine & Rehabilitation, S. Raffaele Arcangelo Fatebenefratelli Hospital, Venice, Italy
                [2 ]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
                University of Glasgow, United Kingdom
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: DV AF. Performed the experiments: MGG. Analyzed the data: AF. Contributed reagents/materials/analysis tools: DV MGG. Wrote the paper: DV AF. Conceived the study: DV.

                Article
                PONE-D-14-03890
                10.1371/journal.pone.0112065
                4234681
                25401967
                ddd8ea8a-5dbc-4125-9e1b-66387b38533b
                Copyright @ 2014

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 8 April 2014
                : 27 August 2014
                Page count
                Pages: 10
                Funding
                The authors have no support or funding to report.
                Categories
                Research Article
                Medicine and health sciences
                Clinical medicine
                Clinical trials
                Phase II clinical investigation
                Critical Care and Emergency Medicine
                Trauma Medicine
                Neurorehabilitation and Trauma
                Health Care
                Physiotherapy
                Neurology
                Neurodegenerative Diseases
                Movement Disorders
                Parkinson Disease
                Research and Analysis Methods
                Research Design
                Case-Control Studies
                Clinical Research Design

                Uncategorized
                Uncategorized

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