The long-term effects of textured shoe insoles on balance, walking abi

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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 participant’s 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