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      Effects of whole-body vibration on sensorimotor deficits and brain plasticity among people with chronic ankle instability: a study protocol for a single-blind randomized controlled trial

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          Abstract

          Background

          Chronic ankle instability (CAI) is a form of musculoskeletal disease that can occur after a lateral ankle sprain, and it is characterized by pain, recurrent ankle sprains, a feeling of “giving way” at the ankle joint, and sensorimotor deficits. There has been increasing evidence to suggest that plastic changes in the brain after the initial injury play an important role in CAI. As one modality to treat CAI, whole-body vibration (WBV) has been found to be beneficial for treating the sensorimotor deficits accompanying CAI, but whether these benefits are associated with brain plasticity remains unknown. Therefore, the current study aims to investigate the effect of WBV on sensorimotor deficits and determine its correlation with plastic changes in the brain.

          Methods

          The present study is a single-blind randomized controlled trial. A total of 80 participants with CAI recruited from the university and local communities will be divided into 4 groups: whole-body vibration and balance training (WBVBT), balance training (BT), whole-body vibration (WBV), and control group. Participants will be given the WBV intervention (25-38 Hz, 1.3-2 mm, 3-time per week, 6-week) supervised by a professional therapist. Primary outcome measures are sensorimotor function including strength, balance, proprioception and functional performance. Brain plasticity will be evaluated by corticomotor excitability, inhibition, and representation of muscles, as measured by transcranial magnetic stimulation. Activation of brain areas will be assessed through functional near-infrared spectroscopy. Secondary outcome measures are self-reported functional outcomes involving the Cumberland Ankle Instability Tool and the Foot and Ankle Ability Measure. All tests will be conducted before and after the WBV intervention, and at 2-week follow-up. Per‑protocol and intention-to-treat analysis will be applied if any participants withdraw.

          Discussion

          This is the first trial to investigate the role of brain plasticity in sensorimotor changes brought by WBV for individuals with CAI. As plastic changes in the brain have been an increasingly important aspect in CAI, the results of the current study can provide insight into the treatment of CAI from the perspective of brain plasticity.

          Trial registration

          Chinese Clinical Trial Registry (ChiCTR2300068972); registered on 02 March 2023.

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          G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences

          G*Power (Erdfelder, Faul, & Buchner, 1996) was designed as a general stand-alone power analysis program for statistical tests commonly used in social and behavioral research. G*Power 3 is a major extension of, and improvement over, the previous versions. It runs on widely used computer platforms (i.e., Windows XP, Windows Vista, and Mac OS X 10.4) and covers many different statistical tests of the t, F, and chi2 test families. In addition, it includes power analyses for z tests and some exact tests. G*Power 3 provides improved effect size calculators and graphic options, supports both distribution-based and design-based input modes, and offers all types of power analyses in which users might be interested. Like its predecessors, G*Power 3 is free.
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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

              High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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                Author and article information

                Contributors
                Jia.Han@Canberra.edu.au
                zouyuzy@zju.edu.cn
                Journal
                BMC Sports Sci Med Rehabil
                BMC Sports Sci Med Rehabil
                BMC Sports Science, Medicine and Rehabilitation
                BioMed Central (London )
                2052-1847
                18 July 2023
                18 July 2023
                2023
                : 15
                : 88
                Affiliations
                [1 ]GRID grid.13402.34, ISNI 0000 0004 1759 700X, Department of Sport and Exercise Science, College of Education, , Zhejiang University, ; 886 Yuhangtang Road, Zhejiang, 310058 Hangzhou China
                [2 ]GRID grid.412543.5, ISNI 0000 0001 0033 4148, School of Elite Sport, , Shanghai University of Sport, ; Shanghai, China
                [3 ]GRID grid.412543.5, ISNI 0000 0001 0033 4148, School of Exercise and Health, , Shanghai University of Sport, ; Shanghai, China
                [4 ]GRID grid.1039.b, ISNI 0000 0004 0385 7472, Research Institute for Sport and Exercise, , University of Canberra, ; Canberra, Australia
                [5 ]GRID grid.449567.d, ISNI 0000 0004 1759 1855, Department of Physical Education Teaching, , Shanghai Sanda University, ; Shanghai, China
                [6 ]GRID grid.507037.6, ISNI 0000 0004 1764 1277, College of Rehabilitation Sciences, , Shanghai University of Medicine and Health Sciences, ; 279 Zhouzhu Highway, Shanghai, 201318 China
                [7 ]GRID grid.1027.4, ISNI 0000 0004 0409 2862, Faculty of Health, Arts and Design, , Swinburne University of Technology, ; VIC Hawthorn, Australia
                Article
                698
                10.1186/s13102-023-00698-0
                10354978
                37464427
                9ea46545-3f99-4439-843d-19d562b428fd
                © The Author(s) 2023

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 28 March 2023
                : 4 July 2023
                Funding
                Funded by: Science and Technology Commission of Shanghai Municipality--Excellent academic leader (youth) of Science and Technology Innovation Action Plan
                Award ID: 20XD1423200
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2023

                whole-body vibration,chronic ankle instability,sensorimotor deficits,brain plasticity,study protocol,randomized controlled trial

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