Relevance: Many people with Multiple Sclerosis (pwMS) experience problems with balance and walking, which can make daily activities difficult and can lead to falls. Improving balance and walking is, therefore, of primary importance in maintaining health, independence, and quality of life in pwMS. Textured shoe insoles have been shown to alter gait and balance, potentially improving stability, in clinical groups with known balance impairments [1,2]. Improved balance might encourage greater participation in physical activity with related general health benefits in pwMS.Purpose: To investigate whether long term wear of textured or smooth insoles alters gait and balance in pwMS.Methods/analysis: The study was a single blinded exploratory randomised controlled trial with three experimental arms: control group (no insole), smooth insole group (3 mm thick ethyl-vinyl-acetate) and textured insole group (3 mm thick EVA with pyramidal peaks). Outcome measures were assessed immediately before and after randomisation and after three months wear. Gait characteristics were measured during level ground walking (GAITRite) and balance was measured during bilateral standing (Kistler force platform). Thirty five community dwelling adults aged over 18 years with a clinical diagnosis of MS were recruited (22 females, 13 males, mean [SD] age 54.0 [11.30] years). Inclusion criteria included participants being free of comorbidities, free from relapse in the last three months and able to walk 100 m independently with or without the use of a unilateral walking aid. Data was analysed using analysis of covariance with statistical significance set at 0.05.Results: At immediate follow up the mean (SD) gait velocities (cm s −1 ) were control 71.0 (6.3); texture 74.4 (6.3); smooth 77.9 (6.2). Mean (SD) minimum anterio-posterior times to boundary of base of support (TTB, seconds) were control 8.2 (1.2): texture 9.2 (1.2): smooth 9.4 (1.2). In both cases only the differences between the control and the smooth groups were statistically significant (p = 0.037 gait velocity, p = 0.049 mean minimum TTB). However, these treatment effects were not maintained at three months. There were no other significant changes in gait characteristics or balance.Discussion and conclusions: Effects of wearing textured insoles were not statistically significant. On immediately wearing the smooth insoles participants walked faster and had a slower TTB, demonstrating better balance and a more confident gait pattern. This effect was not maintained after 3 months but this could be due to the relatively small sample size.Impact and implications: This is the first longitudinal exploratory randomised controlled trial to investigate textured insoles for people with MS. Its findings are useful for clinicians interested in insoles as a potential adjunct to usual care. These results do not support a long-term benefit of textured insoles to functional ability. The findings are not definitive but can inform further research and will enable the design of fully powered trials.Releva...