Textured insoles for gait and balance impairment in MS
Research type
Research Study
Full title
The long-term effects of textured shoe insoles on balance, walking ability and function in people with MS.
IRAS ID
140937
Contact name
Yael Jennifer Baron
Contact email
Sponsor organisation
Teesside University
Research summary
The project will investigate whether wearing textured insoles in shoes has a beneficial effect on gait, balance and function in people with Multiple Sclerosis (MS). Impairments of gait and balance are common symptoms of MS and cause significant reduction of independence and quality of life. Limited preliminary evidence exists from pilot studies to show that MS patients may benefit from wearing textured insoles (Kelleher et al., 2010; Dixon et al., 2013). The previous feasibility/pilot work by this group (Dixon et al., 2013, funded by the MS Society) was a Phase I study (Medical Research Council Framework, 2000) which showed benefits after 2 weeks. In accordance with the MRC Framework, that study was of a pre-post design without a control group to provide preliminary evidence of possible effect. The proposed study will be a Phase II exploratory randomised controlled trial as recommended in the MRC Framework of 2000 and 2008 (Medical Research Council Framework, 2008). This will investigate benefits in a controlled trial and over a longer period of 3 months. A textured insole that has already been shown to benefit a healthy population and an MS population will be investigated (Hatton et al., 2011; Dixon et al., 2013). A smooth insole placebo group and a no-insole control group will be included.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/0043
Date of REC Opinion
20 Mar 2014
REC opinion
Further Information Favourable Opinion