The effects of prolonged wear of textured shoe insoles on gait, foot sensation and proprioception in people with multiple sclerosis: study protocol for a randomised controlled trial.

Anna L Hatton,Katrina Williams,John Dixon,Graham Kerr,Sandra G Brauer,Keith Rome

doi:10.1186/s13063-016-1337-x

Abstract

BackgroundMany people with multiple sclerosis experience problems with walking, which can make daily activities difficult and often leads to falls. Foot sensation plays an important role in keeping the body balanced whilst walking; however, people with multiple sclerosis often have poor sensation on the soles of their feet. Wearing a specially designed shoe insole, which enhances plantar sensory information, could help people with multiple sclerosis to walk better. This study will explore whether long-term wear of a textured insole can improve walking in people with multiple sclerosis.MethodsA prospective randomised controlled trial with two parallel groups will be conducted aiming to recruit 176 people with multiple sclerosis living in the community (Brisbane, Australia). Adults with a clinical diagnosis of multiple sclerosis, Disease Steps score 1–4, who are ambulant over 100 m and who meet specific inclusion criteria will be recruited. Participants will be randomised to a smooth control insole (n = 88) or textured insole (n = 88) group. The allocated insole will be worn for 12-weeks within participants’ own footwear, with self-report wear diaries and falls calendars being completed over this period. Blinded assessors will conduct two baseline assessments and one post-intervention assessment. Gait tasks will be completed barefoot, wearing standardised footwear only, and wearing standardised footwear with smooth and textured insoles. The primary outcome measure will be mediolateral base of support when walking over even and uneven surfaces. Secondary measures include spatiotemporal gait parameters (stride length, stride time variability, double-limb support time, velocity), gait kinematics (hip, knee, and ankle joint angles, toe clearance, trunk inclination, arm swing, mediolateral pelvis/head displacement), foot sensation (light touch-pressure, vibration, two-point discrimination) and proprioception (ankle joint position sense). Group allocation will be concealed and all analyses will be based on an intention-to-treat principle.DiscussionThis study will explore the effects of wearing textured insoles over 12-weeks on gait, foot sensation and proprioception in people with multiple sclerosis. The study has the potential to identify a new, evidence-based footwear intervention which has the capacity to enhance mobility and independent living in people with multiple sclerosis.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12615000421538. Registered 4 May 2015.

Highlights

Many people with multiple sclerosis experience problems with walking, which can make daily activities difficult and often leads to falls
The primary aim of this study is to explore whether prolonged wear of textured insoles alters ML base of support from baseline assessment 2 to the post-intervention assessment
Gait impairment is one of the most disabling and debilitating complaints reported by people with multiple sclerosis (pwMS) [5]

Summary

Introduction

Many people with multiple sclerosis experience problems with walking, which can make daily activities difficult and often leads to falls. Wearing a specially designed shoe insole, which enhances plantar sensory information, could help people with multiple sclerosis to walk better. This study will explore whether long-term wear of a textured insole can improve walking in people with multiple sclerosis. Falls are a major threat to the health and well-being of people with multiple sclerosis (pwMS) [1, 2]. Impaired mobility and balance are two major risk factors for falls in pwMS [2]. 85 % of pwMS reported gait disturbances as their main complaint [4] and continued loss of mobility amongst their greatest concerns for the future [5]. Interventions that effectively preserve or enhance walking capacity are paramount to improving quality of life and maintaining independence

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