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Trial registered on ANZCTR


Registration number
ACTRN12615000421538
Ethics application status
Approved
Date submitted
22/04/2015
Date registered
4/05/2015
Date last updated
4/06/2019
Date data sharing statement initially provided
22/03/2019
Date results information initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of prolonged wear of textured shoe insoles on walking in people with Multiple Sclerosis
Scientific title
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
Secondary ID [1] 286578 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 294838 0
Walking Impairment 294839 0
Falls Risk 294859 0
Condition category
Condition code
Neurological 295109 295109 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 295118 295118 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 291694 0
Treatment: Other
Intervention code [2] 291724 0
Treatment: Devices
Comparator / control treatment
Flat, control insoles (Medium Density EVA, 3mm thickness, shore value A50, black, OG1304; Algeos Ltd., Liverpool, UK) - constructed plain EVA material, which has a flat surface with no indentations. Participants will be instructed to wear the flat control 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.
Control group
Placebo

Outcomes
Primary outcome [1] 294876 0
Temporospatial Gait Parameters:
Base of Support, Stride Length, Stride Time Variability, Double-Limb Support Time, Gait Velocity during walking over even and uneven surfaces.
Measured using an electronic walkway (GAITRite) and motion capture system (Vicon).
Timepoint [1] 294876 0
Measured at:
Baseline Assessment 1 (Upon entry into study)
Baseline Assessment 2 (4 weeks after Baseline Assessment 1, prior to the commencement of insole use)
Assessment 3 (3-months after the commencement of insole use)
Secondary outcome [1] 314264 0
Gait Kinetics:
Lower limb and trunk muscle activation during walking over even and uneven surfaces.
Measured using surface electromyography.
Timepoint [1] 314264 0
Measured at:
Baseline Assessment 1 (Upon entry into study)
Baseline Assessment 2 (4 weeks after Baseline Assessment 1, prior to the commencement of insole use)
Assessment 3 (3-months after the commencement of insole use)
Secondary outcome [2] 314265 0
Gait Kinematics:
Lower limb joint and trunk movement
Measured using a motion capture system (Vicon)
Timepoint [2] 314265 0
Measured at:
Baseline Assessment 1 (Upon entry into study)
Baseline Assessment 2 (4 weeks after Baseline Assessment 1, prior to the commencement of insole use)
Assessment 3 (3-months after the commencement of insole use)
Secondary outcome [3] 314266 0
Foot Sensation and Proprioception:
Light-touch sensation, Vibration sense, Two-point discrimination, Ankle joint position sense.
Measured using monofilaments, tuning fork, 2-point discriminator, and 2-dimensional webcam kinematic software analysis application.
Timepoint [3] 314266 0
Measured at:
Baseline Assessment 1 (Upon entry into study)
Baseline Assessment 2 (4 weeks after Baseline Assessment 1, prior to the commencement of insole use)
Assessment 3 (3-months after the commencement of insole use)

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomized to either the control insole or textured insole group. The randomisation schedule will be generated and maintained by an offsite investigator and revealed via telephone to a second Research Assistant, prior to Baseline 2 Assessment. The Principal Investigator, first Research Assistant, and all other Co-Investigators will remain blinded to the insole group allocation. Participants will be instructed not to divulge their group allocation. Following Baseline Assessment 2, the Principal Investigator and first Research Assistant will leave the gait laboratory to ensure blinding to the insole condition. The second Research Assistant will then fit the participant with their allocated insole, and provide advice regarding; frequency of wear, completion of insole wear diaries, and emergency contact details for local podiatry care. The second Research Assistant will not be involved in any aspects of data collection or analysis.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The schedule will be generated using simple randomisation by way of a randomisation table created by computer software (computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size was calculated for our primary outcome measure, base of support during even surface walking, based on our pilot data. Our preliminary study reported mean (SD) readings at baseline for base of support of 13.78 (5.11) cm and a significant mean change of -1.66 cm (P=0.02) at 2-week follow up. With a power of 80%, and alpha level set to 0.05, a calculation for two related groups gave a figure of n=76. In our pilot study we recruited 46 people with MS, of whom 100% completed all tests (2 visits). As this exploratory RCT involves a longer intervention period, we will allow for a 15% attrition rate. An 85% retention rate over a 4-month period (baseline assessment at 1 month, intervention 3-months) is accurate and appropriate, based on previous MS intervention studies. Three RCTs with 3-month intervention periods conducted in people with MS, report retention rates of 82%, 88%, and 90%. Other RCTs conducted in people with MS report retention rates of 88% over 1-month, 86% and 95% over 7-weeks, and 80%, 83%, and 96% over 6-months. Therefore, 88 participants per group will be recruited, giving a total of n=176. This will be a suitably large sample size for this exploratory trial to provide estimates of effect sizes and yield between-group confidence intervals to inform a future full-scale RCT.

Data will be analysed using SPSS and MATLAB software. All analyses will be conducted in a blinded manner, on an intention-to-treat basis. To determine if there is any difference between intervention and control groups in gait, foot sensation or proprioception over the intervention period a repeated measures mixed models approach will be undertaken using data at baseline and 3-months. Non-parametric tests will be used where data is not normally distributed or violates the assumption of sphericity. Participant characteristics (e.g. age, gender, height) will be included as covariates. Multiple regression modelling will be used to determine any relationships between foot sensation (light touch-pressure, vibration, and two-point discrimination), proprioception (joint position sense) and gait.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291139 0
Charities/Societies/Foundations
Name [1] 291139 0
Multiple Sclerosis Research Australia
Address [1] 291139 0
Level 26, Northpoint, 100 Miller Street, North Sydney NSW 2060
Country [1] 291139 0
Australia
Primary sponsor type
Individual
Name
Dr Anna Hatton
Address
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 289818 0
Individual
Name [1] 289818 0
Professor Sandra Brauer
Address [1] 289818 0
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, QLD 4072
Country [1] 289818 0
Australia
Secondary sponsor category [2] 289819 0
Individual
Name [2] 289819 0
Professor Graham Kerr
Address [2] 289819 0
Institute of Health & Biomedical Innovation, School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, Brisbane, QLD 4059
Country [2] 289819 0
Australia
Secondary sponsor category [3] 289820 0
Individual
Name [3] 289820 0
Professor Keith Rome
Address [3] 289820 0
Auckland University of Technology, 90 Akoranga Drive, AA Building, Northcote 0627, Auckland.
Country [3] 289820 0
New Zealand
Secondary sponsor category [4] 289821 0
Individual
Name [4] 289821 0
Dr John Dixon
Address [4] 289821 0
Health and Social Care Institute, School of Health and Social Care, Borough Road, Teesside University, Middlesbrough, TS1 3BA
Country [4] 289821 0
United Kingdom
Secondary sponsor category [5] 289822 0
Individual
Name [5] 289822 0
Ms Katrina Williams
Address [5] 289822 0
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, QLD 4072
Country [5] 289822 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292716 0
Medical Research Ethics Committee
Ethics committee address [1] 292716 0
Human Ethics, Research Management Office, UQ Research and Innovation, Cumbrae-Stewart Building (#72), St Lucia, QLD 4072
Ethics committee country [1] 292716 0
Australia
Date submitted for ethics approval [1] 292716 0
Approval date [1] 292716 0
22/07/2014
Ethics approval number [1] 292716 0
2014000871
Ethics committee name [2] 292717 0
University Human Research Ethics Committee
Ethics committee address [2] 292717 0
Office of Research Ethics and Integrity, Queensland University of Technology, Kelvin Grove, QLD 4059
Ethics committee country [2] 292717 0
Australia
Date submitted for ethics approval [2] 292717 0
06/04/2015
Approval date [2] 292717 0
Ethics approval number [2] 292717 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56726 0
Dr Anna Hatton
Address 56726 0
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, Brisbane, QLD 4072
Country 56726 0
Australia
Phone 56726 0
+61733654590
Fax 56726 0
Email 56726 0
a.hatton1@uq.edu.au
Contact person for public queries
Name 56727 0
Dr Dr Anna Hatton
Address 56727 0
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, Brisbane, QLD 4072
Country 56727 0
Australia
Phone 56727 0
+61733654590
Fax 56727 0
Email 56727 0
a.hatton1@uq.edu.au
Contact person for scientific queries
Name 56728 0
Dr Anna Hatton
Address 56728 0
School of Health and Rehabilitation Sciences, Therapies Building (84A), The University of Queensland, St Lucia, Brisbane, QLD 4072
Country 56728 0
Australia
Phone 56728 0
+61733654590
Fax 56728 0
Email 56728 0
a.hatton1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethical approval for this study requires that individual participant data be kept confidential. Further approval from the ethics committee will be sought before IPD is made available.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary