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The effects of prolonged wear of textured shoe insoles on walking in people with Multiple Sclerosis

Can gait be improved by way of plantar tactile stimulation? An exploratory randomized controlled trial of the effects of prolonged wear of textured shoe insoles in people with Multiple Sclerosis

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000421538
Enrollment
41
Registered
2015-05-04
Start date
2016-03-07
Completion date
2017-11-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Many people with Multiple Sclerosis (MS) experience problems with walking, which can make day to day activities difficult and often leads to falls. Improving walking ability is, therefore, of primary importance in maintaining health, independence, and quality of life in people living with MS. Walking problems in MS are often caused by a combination of typical symptoms, such as altered function of muscles, nerves, and senses. The key to improving mobility is, therefore, to use a range of different treatment techniques which address each of these symptoms. Foot sensation plays an important role in keeping the body upright and balanced whilst walking, yet, we know from previous studies that people with MS often have poor sensation on the soles of their feet. It is, therefore, possible that wearing a specially designed shoe insole, which enhances sensory information at the feet, could help people affected by MS to walk better. This would offer health care professionals a new, additional treatment technique to help manage walking problems in MS. This study will explore whether long-term wear of a textured shoe insole can improve walking in people with MS. We will analyse how people with MS walk over an even and uneven surface, when they are wearing the insoles for the first time, and after wearing the insoles for three months. We will explore whether wearing the insoles changes the way the body moves, or the leg and trunk muscles work during walking. We will also monitor any changes in the perception of foot sensation and the awareness of foot position, to help us better understand how our insoles may bring about their effects on walking. The benefit for people affected by MS is that this study could lead to the development of a new treatment technique, specifically an inexpensive, easy-to-administer shoe insole, which could help towards improving mobility and independent living.

Interventions

Textured shoe insoles (Evalite Pyramid EVA, 3mm thickness, shore value A50, black, OG1549; Algeos Ltd, Liverpool, UK) - constructed from EVA soling material, which has small, pyramidal peaks with centre-to-centre distances of approximately 2.5mm. Participants will be instructed to wear the textured insoles, in their own shoes, as much as possible over the 3-month intervention period. Participants will be followed for 3-months with insole-wear diaries to determine the number of hours insoles are

Textured shoe insoles (Evalite Pyramid EVA, 3mm thickness, shore value A50, black, OG1549; Algeos Ltd, Liverpool, UK) - constructed from EVA soling material, which has small, pyramidal peaks with centre-to-centre distances of approximately 2.5mm. Participants will be instructed to wear the textured insoles, in their own shoes, as much as possible over the 3-month intervention period. Participants will be followed for 3-months 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.

Sponsors

Dr Anna Hatton
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Men and women aged >18 years, with a clinical diagnosis of Multiple Sclerosis; Disease Steps grading 1-4; and ambulant over 100 metres with or without the use of an assistive device (cane/crutch).

Exclusion criteria

Neurological conditions other than Multiple Sclerosis; Peripheral neuropathy to a degree that would preclude the ability to perceive the textured insole; Currently being prescribed over-the-counter or custom-made foot orthoses; Cardiovascular or orthopaedic conditions including recent injury to the back or legs limiting ambulation; Unstable psychiatric condition; Cognitive impairment. Participants who report a formal exacerbation of Multiple Sclerosis symptoms persisting >24hrs, four weeks prior to, or at any time during, the intervention period will be excluded from the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 13, 2026