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?
90 people with MS will be recruited. They must be aged between 18 and 65, with a clinical diagnosis of MS and have the ability to walk independently for 100 metres with or without a unilateral walking aid.
What does the study involve?
Participants will be invited to attend sessions at the Teesside Centre for Rehabilitation Science in James Cook University Hospital (UK). Their gait characteristics and balance control will be tested. They will be 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 will be tested if this is too low they will not be able to take part. Participants will be randomly allocated to one of three groups: textured insole group, smooth insole group or control group (no insole). They will be asked to wear the insole during their normal daily activities for three months, after which the testing procedure will be repeated in all three groups. At the end of the study, participants will be 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 will not necessarily be 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 will be present for support should participants require it and the chief investigator, a qualified physiotherapist, will be beside participants all of the time. Participants will be able to rest between tests. There is also a possibility that some participants may find the insoles uncomfortable. Participants will be 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?
The study will be conducted in the Teesside Centre for Rehabilitation Science, Teesside University in James Cook University Hospital, Middlesbrough, UK.
When is the study starting and how long is it expected to run?
April 2014 April 2015
Who is funding the study?
Multiple Sclerosis Society in the UK
Who is the main contact?
Dr Yael Jenny Baron
Dr Yael Jennifer Baron
School of Health and Social Care
The long-term effects of textured shoe insoles on balance, walking ability and function in people with multiple sclerosis: an exploratory randomised controlled trial
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.
1. Teesside University School of Health & Social Care Research Governance and Ethics Committee, 17 March 2014, ref: 181/13
2. North EastNewcastle and North Tyneside 2 National Research Ethics Service Research Ethics Committee, 20 March 2014, ref: 14/NE/0043
Single-blinded exploratory randomised controlled trial with three arms
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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
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, as measured by the timed-up-and-go test.
4. Qualitative information regarding acceptability and comfort of the insole interventions, gathered in semi structured 5. interviews and focus groups at the end of the study.
Secondary outcome measures
1. Self reported health: EQ-5D-5L
2. Self reported fatigue: Modified fatigue impact scale
3. Self reported pain level: Medical Outcomes Study (MOS) pain effects scale
4. Self reported cognitive deficits: Perceived deficits questionnaire
5. Self reported fear of falling: Falls efficacy scale International
6. Self reported walking ability: MS Walking Scale (MSWS12)
Overall trial start date
Overall trial end date
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
School of Health and Social Care
Multiple Sclerosis Society (UK) - grant reference 972/12
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting