Introduction 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.
Methods and analysis 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.
Ethics and dissemination 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.
Trial registration number ACTRN12617000543381; Pre-results.
- diabetic neuropathy
- diabetes and endocrinology
- rehabilitation medicine
- preventative medicine
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Contributors ALH led the conception, design and writing of the study protocol with substantial contributions to the design, writing, critical review of intellectual content and final manuscript approval from EMG, JNM, JB, JP, GK and KR. All authors agree to be accountable for their work. As principal investigator, ALH takes overall responsibility for the work. EMG made substantial contributions (as the first research assistant) to participant recruitment and data collection strategies in the development and initial stages of the study and protocol. JNM (as the study podiatrist), provided specific expertise in the development and construction of the textured and smooth insoles, dispensing the insoles and providing clinical support to participants over the intervention period. JB, JP, KR and GK made substantial contributions to the trial design and statistical analysis strategy. JP and KR were also responsible for providing expertise concerning the clinical management of diabetic feet. GK provided expertise in all biomechanical testing procedures and outcome measures.
Funding This work is supported by a 2017 Diabetes Australia Research Program General Grant (Y17G-HATA),awarded to ALH, JB, JP, GK and KR.
Competing interests Materials used to construct the textured and smooth insoles investigated in this study were supplied by Algeos PTY Ltd. (VIC, Australia). The company had no involvement in the conception or design of the study or preparation of this manuscript; and will not be involved in subsequent data acquisition, analysis or interpretation.
Ethics approval The study has been approved by the UQ Human Research Ethics Committee (#2017000098).
Provenance and peer review Not commissioned; externally peer reviewed.
Patient consent for publication Not required.
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