Plain English Summary
Background and study aims
Multiple sclerosis (MS) is a disease affecting nerves in the brain and spinal cord. Impairments of gait and balance are common symptoms of MS and cause significant reduction of independence and quality of life. Gait and balance are impaired as a result of several of the primary symptoms of MS, one of which is peripheral sensory loss. MS patients can develop reduced sensation in the soles of their feet as a result. Sensation in the soles of the feet has been shown to be important in the control of gait and balance so its loss contributes to the development of gait and balance impairments. Wearing textured insoles in shoes is a method of increasing stimulation of the soles of the feet. Textured insoles have been found to improve the gait and balance of elderly people who also have reduced sensation in their feet. initial studies over short periods of time have shown that MS patients may also benefit from wearing textured insoles. A larger study is now needed to give more evidence and show how insoles can help. The aim of this study is to investigate whether textured insoles improve the walking ability of people with MS when they are worn for a period of three months and to find out how acceptable textured insoles are to them.
Who can participate?
People aged between 18 and 65 with a clinical diagnosis of MS and the ability to walk independently for 100 metres with or without a unilateral walking aid.
What does the study involve?
Participants are invited to attend sessions at the Teesside Centre for Rehabilitation Science in James Cook University Hospital (UK). Their gait characteristics and balance control are tested. They are asked to complete some questionnaires about how they regard their health and how their symptoms impact on their lives. Before taking part in the study, the sensitivity of each participants foot sole is tested - if this is too low they are not able to take part. Participants are randomly allocated to one of three groups: textured insole group, smooth insole group or control group (no insole). They are asked to wear the insole during their normal daily activities for three months, after which the testing procedure is repeated in all three groups. At the end of the study, participants are invited to take part in focus groups to share their experience of wearing the insoles. Focus groups are not compulsory.
What are the possible benefits and risks of participating?
Taking part is necessarily beneficial, but textured insoles of this type have been shown to help people with MS in an initial study so there may be some benefit to gait and balance. There is a small risk of falls during the gait and balance testing. To prevent falls, bars and handles are present for support should participants require it and the chief investigator, a qualified physiotherapist, is beside participants all of the time. Participants are able to rest between tests. There is also a possibility that some participants may find the insoles uncomfortable. Participants are advised to contact the chief investigator if this is the case and to stop wearing the insoles if they find them too uncomfortable. The team supervising the study and the clinicians responsible for participants care feel that the risks are minimal.
Where is the study run from?
Teesside Centre for Rehabilitation Science, Teesside University in James Cook University Hospital, Middlesborough (UK)
When is the study starting and how long is it expected to run?
April 2014 to May 2016
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Dr Yael Jenny Baron
j.baron@tees.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Yael Jennifer Baron
ORCID ID
Contact details
School of Health and Social Care
Teesside University
Middlesbrough
TS1 3BA
United Kingdom
-
j.baron@tees.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
972/12
Study information
Scientific title
The long-term effects of textured shoe insoles on balance, walking ability and function in people with multiple sclerosis: an exploratory randomised controlled trial
Acronym
Study hypothesis
It is hypothesised that wearing textured insoles will improve the gait and balance of people with MS due to the increase in sensory stimulation to the soles of their feet. The null hypothesis is that textured insoles will make no difference to gait and balance ability compared to baseline measures.
Ethics approval
1. Teesside University School of Health & Social Care Research Governance and Ethics Committee, 17/03/2014, ref: 181/13
2. North EastNewcastle and North Tyneside 2 National Research Ethics Service Research Ethics Committee, 20/03/2014, ref: 14/NE/0043
Study design
Single-blinded exploratory randomised controlled trial with three arms
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Multiple sclerosis
Intervention
Patients are randomised to three arms:
1. Intervention - textured insoles (Evalite Pyramid EVA 3mm thickness, Algeos Ltd.)
2. Control - smooth insole (medium density EVA, 3mm thickness, Algeos Ltd.)
3. Control - no insole
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Spatio-temporal parameters of gait, recorded by an electronic GAITRite mat
2. Standing balance during quiet bipedal stance, recorded by a Kistler (TM) force plate
3. Functional mobility, measured by the timed-up-and-go test
4. Qualitative information regarding acceptability and comfort of the insole interventions, gathered in semi-structured interviews and focus groups at the end of the study
Secondary outcome measures
1. Self-reported health, measured using the EQ-5D-5L
2. Self-reported fatigue, measured using the modified fatigue impact scale
3. Self-reported pain level, measured using the Medical Outcomes Study (MOS) pain effects scale
4. Self-reported cognitive deficits, measured using the perceived deficits questionnaire
5. Self-reported fear of falling, measured using the falls efficacy scale International
6. Self-reported walking ability, measured using the MS Walking Scale (MSWS12)
Overall trial start date
01/04/2014
Overall trial end date
06/05/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Be aged between 18 and 65
2. Have a clinical diagnosis of MS
3. Be able to walk 100m independently, with or without a unilateral walking aid
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
90
Participant exclusion criteria
1. Current acute exacerbation and/or relapse of symptoms within the last three months
2. Diagnoses of any other condition affecting the central nervous system, for example Parkinsons Disease
3. Any musculoskeletal injury or condition for which a health professional has advised the person to refrain from undertaking moderate physical activity
4. Inability to give informed consent
5. Inability to read or speak English
6. Inability to feel the textured insoles (foot sole sensitivity tested using Semmes-Weinstein monofilaments to exclude people with peripheral neuropathy)
7. Current use of textured insoles or shoes with textured insoles
Recruitment start date
01/04/2014
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Teesside University
Middlesbrough
TS1 3BA
United Kingdom
Funders
Funder type
Charity
Funder name
Multiple Sclerosis Society - grant reference 972/12
Alternative name(s)
MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Dissemination at:
1. ER-WCPT 4th European Congress, Liverpool, UK November 2016: Long-term effect of textured insoles on gait and balance in people with Multiple Sclerosis: an exploratory randomised controlled trial (Y. J. Baron, A. Hatton, J. Robinson, D. Hodgson, P. O. McKeon, K. Rome, D. Martin, J. Dixon)
2. Participant perception of the effect of textured insoles on balance and gait in people with Multiple Sclerosis (Y. J. Baron, A. Hatton, J. Robinson, D. Hodgson, P. O. McKeon, K. Rome, D. Martin, J. Dixon)
Work also published at:
1. Y.J. Baron, A. Hatton, J. Robinson, D. Hodgson, P. McKeon, K. Rome, D. Martin, J. Dixon, Long-term effect of textured insoles on gait and balance in people with multiple sclerosis: an exploratory randomised controlled trial, Physiotherapy, 102 (Suppl 1) 2016; p. e57
2. Y. Baron, A. Hatton, J. Robinson, D. Hodgson, P. McKeon, K. Rome, D. Martin, J. Dixon, Participant perception of the effect of textured insoles on balance and gait in people with multiple sclerosis, Physiotherapy, 102 (Suppl 1) 2016; p. e58-e59
Dissemination event:
Multiple Sclerosis research dissemination event: improving balance in people with multiple sclerosis,
The Curve, Teesside University, Middlesbrough, TS1 3BA
Thursday 30th March, 10.30-12.00 http://www.tees.ac.uk/sections/whats_on/events_details.cfm?event_id=9057
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Yael Jennifer Baron (yael.baron@nuth.nhs.uk)
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary