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

• Register: ANZCTR
• Last refreshed on: 10 March 2020
• Main ID: ACTRN12617000543381
• Date of registration: 18/04/2017
• Prospective Registration: Yes
• Primary sponsor: Dr Anna Hatton
• Public title: Do different shoe insole surfaces affect balance and walking in adults with diabetes and foot nerve damage?
• Scientific title: Do different shoe insole surfaces affect balance and walking in adults with diabetic peripheral neuropathy? A randomised controlled trial
• Date of first enrolment: 16/11/2017
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12617000543381.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Anna Hatton

• Name: Dr Anna Hatton

Key inclusion & exclusion criteria

Inclusion criteria: 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 criteria: 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

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Metabolic and Endocrine - Diabetes

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Diabetic Peripheral Neuropathy;Type 2 Diabetes;Balance and Walking Impairment;Falls Risk;
Diabetic Peripheral Neuropathy
Type 2 Diabetes
Balance and Walking Impairment
Falls Risk

Intervention(s)

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.

Primary Outcome(s)

Foot Sensation and Proprioception:

Light-touch sensation, vibration sense, ankle joint position sense. Measured using monofilaments, neurothesiometer, and 2-dimensional webcam kinematic software analysis application.
[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Centre of Pressure Movement during Standing Balance:

Centre of pressure path velocity, range and standard deviation of centre of pressure movement in anterior-posterior and mediolateral directions during unperturbed, double-limb standing, performed on a firm and foam surface, with eyes open and eyes closed. Measured using a force platform (AMTI). [Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Spatiotemporal Gait Parameters:

Base of support, stride length, double-limb support time, gait velocity during walking over a level-ground surface. Measured using an electronic walkway system (GAITRite).
[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Secondary Outcome(s)

Fear of Falling:

Falls Efficacy Scale-International (a questionnaire that measures fear of falling).[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Self-Reported Foot Health:

Foot Health Status Questionnaire (a measure of self-perceived foot-health specific, quality of life before and after an intervention).[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)]

Number of Falls:

Number of self-reported falls in the previous 12 months and over the intervention period (measured using a falls diary).[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Physical Activity:

Duration/bouts of physical activity (min/day), as a measure of habitual weekly activity levels. Measured using a wireless activity monitor (activPAL, Glasgow, Scotland), worn for 7 consecutive days.[Baseline Assessment (Upon entry into study)
Post-Intervention Assessment (4-weeks after the commencement of insole use)
]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Diabetes Australia

Secondary Sponsor(s)

Dr Joanne Paton

Professor Keith Rome

Professor Graham Kerr

Professor Joshua Burns

Ethics review

Status: Approved
Approval date: 10/04/2017
Contact:

University of Queensland Human Research Ethics Committee