Show simple item record

dc.contributor.authorHatton, ALen
dc.contributor.authorGane, EMen
dc.contributor.authorMaharaj, JNen
dc.contributor.authorBurns, Jen
dc.contributor.authorPaton, Jen
dc.contributor.authorKerr, Gen
dc.contributor.authorRome, Ken
dc.date.accessioned2019-10-22T07:38:35Z
dc.date.available2019-10-22T07:38:35Z
dc.date.issued2019-07-17en
dc.identifier.issn2044-6055en
dc.identifier.urihttp://hdl.handle.net/10026.1/15002
dc.descriptionNo embargo required.en
dc.description.abstract

<jats:sec><jats:title>Introduction</jats:title><jats:p>Peripheral neuropathy is a major risk factor for falls in adults with diabetes. Innovative footwear devices which artificially manipulate the sensory environment at the feet, such as textured shoe insoles, are emerging as an attractive option to mitigate balance and walking problems in neuropathic populations. This study aims to explore whether wearing textured insoles for 4 weeks alters balance performance in adults with diabetic peripheral neuropathy.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>A prospective, single-blinded randomised controlled trial with parallel groups will be conducted on 70 adults with diabetic peripheral neuropathy. Adults with a diagnosis of peripheral neuropathy (secondary to type 2 diabetes), aged ≥18 years, ambulant over 20 m (with/without an assistive device), will be recruited. Participants will be randomised to receive a textured insole (n=35) or smooth insole (n=35), to be worn for 4 weeks. During baseline and post intervention assessments, standing balance (foam/firm surface; eyes open/closed) and walking tasks will be completed barefoot, wearing standard shoes only, and two different insoles (smooth, textured). The primary outcome measure will be centre of pressure (CoP) velocity, with higher values indicating poorer balance. Secondary outcome measures include walking quality (gait velocity, base of support, stride length and double-limb support time), physical activity levels, foot sensation (light-touch pressure, vibration) and proprioception (ankle joint position sense), and other balance parameters (CoP path length, anteroposterior and mediolateral excursion). Patient-reported outcomes will be completed evaluating foot health, frequency of falls and fear of falling. Data will be analysed using a repeated measures mixed models approach (including covariates) to establish any differences between-groups, for all outcome measures, over the intervention period.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>Ethical approval has been obtained from the institutional Human Research Ethics Committee (#2017000098). Findings will be disseminated at national and international conferences, through peer-reviewed journals, workshops and social media.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>ACTRN12617000543381; Pre-results.</jats:p></jats:sec>

en
dc.format.extente026240 - e026240en
dc.languageenen
dc.language.isoenen
dc.publisherBMJ Publishing Groupen
dc.titleTextured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trialen
dc.typeJournal Article
plymouth.issue7en
plymouth.volume9en
plymouth.journalBMJ Openen
dc.identifier.doi10.1136/bmjopen-2018-026240en
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/School of Health Professions
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Institute of Health and Community
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dcterms.dateAccepted2019-06-11en
dc.rights.embargodate2019-11-27en
dc.identifier.eissn2044-6055en
dc.rights.embargoperiodNot knownen
rioxxterms.versionofrecord10.1136/bmjopen-2018-026240en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2019-07-17en
rioxxterms.typeJournal Article/Reviewen


Files in this item

Thumbnail
Thumbnail

This item appears in the following Collection(s)

Show simple item record


All items in PEARL are protected by copyright law.
Author manuscripts deposited to comply with open access mandates are made available in accordance with publisher policies. Please cite only the published version using the details provided on the item record or document. In the absence of an open licence (e.g. Creative Commons), permissions for further reuse of content should be sought from the publisher or author.
Theme by 
@mire NV