RecruitingACTRN12617000543381

Do different shoe insole surfaces affect balance and walking in adults with diabetes and foot nerve damage?

Do different shoe insole surfaces affect balance and walking in adults with diabetic peripheral neuropathy? A randomised controlled trial


Sponsor

Dr Anna Hatton

Enrollment

70 participants

Start Date

Nov 16, 2017

Study Type

Interventional

Conditions

Summary

Many people with diabetes experience problems with their balance and walking, which can make day to day activities difficult and increase the chance of sustaining a fall. Nerve damage (a common complication of diabetes) can severely disrupt the quality of the signals transmitted from the feet to the brain, which provide vital cues about the ground we stand on and the relative position of our body above, to help people remain upright. Novel footwear devices are emerging as an attractive treatment option to help alleviate balance and walking problems and reduce the risk of falling in adults with diabetic peripheral neuropathy (nerve damage). Textured shoe insoles (comprising raised nodules) are designed to enhance the signals from foot skin receptors, which is important for good balance. This randomized controlled trial will be the first to explore whether use of different shoe insole surfaces (over 4-weeks) can improve balance and walking performance in adults with diabetic peripheral neuropathy. We will also investigate whether any alterations in balance or walking are associated with underlying changes in the amount of remaining feeling in participants’ feet (measures of foot sensation and foot position awareness). Additionally, we will explore whether wearing different shoe insole surfaces lead to improvements in physical activity levels or measures of self-reported foot heath and falls in adults with diabetic peripheral neuropathy. This study will bring new perspective to our understanding of the therapeutic role of footwear interventions, as a means to address deficient postural control in adults with neuropathic changes at the feet. The findings will be used to inform the development of new rehabilitative approaches that will help advance clinical guidelines and policy, and reduce the escalating personal, societal and economic burden of falls in people with diabetes.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Men and women aged 18 years or above; with a clinical diagnosis of peripheral neuropathy secondary to Type 2 diabetes; ambulant over 20 metres with/without the use of an assistive device (cane/crutch), willing to wear shoe insoles for 4 weeks and; have adequate English communication skills.

Exclusion Criteria7

  • Current foot ulceration or lower limb injury
  • Major lower limb amputation
  • Currently using over-the-counter or custom-made foot orthoses/insoles
  • Charcot Arthropathy
  • Neurological disease
  • Cardiorespiratory conditions that limit ambulation
  • Cognitive impairment

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Interventions

Textured insoles constructed from 3.2mm poron (Poron 4000, Algeos Ltd., VIC, Australia), covered with 100% PVC material which has raised pyramidal nodules (Techno PVC covering, Black Tech, Algeos Ltd.

Textured insoles constructed from 3.2mm poron (Poron 4000, Algeos Ltd., VIC, Australia), covered with 100% PVC material which has raised pyramidal nodules (Techno PVC covering, Black Tech, Algeos Ltd., VIC, Australia). To reduce the risk of ulceration, the textured zone will extend from the heel to just posterior to the metatarsal heads (foot region most prone to ulcers). Participants will be instructed to wear the textured insoles, in their own shoes, as much as possible over the 4-week intervention period. Participants will be followed for 4-weeks with insole-wear diaries to determine the number of hours insoles are worn. All participants will receive emergency contact details for a local podiatrist, who will provide advice and podiatry care for participants, as required.


Locations(1)

QLD, Australia

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