McLoughlin et al. Effect of wearing a dorsiflexion assist orthosis on mobility, perceived fatigue and exertion during the six-minute walk test in people with multiple sclerosis: a randomised cross-over protocol. BMC Neurol. 2012 May 25;12(1):27.
BACKGROUND: Fatigue in combination with gait and balance impairments can severely limit daily activities in MSers. Generalised fatigue has a major impact on walking ability, with moderately disabled
MSers experiencing difficulty in walking extended distances. Localised motor fatigue in the ankle dorsiflexors can lead to foot drop, further reducing functional ambulation. The aim of this study is to evaluate the effect of a simple dynamic dorsiflexion assist orthosis on walking-induced fatigue, gait, balance and functional mobility in
METHODS: A randomised cross-over trial will be conducted with 40 community dwelling
MSers with mild to moderate mobility disability. Participants will initially be screened for disease severity, balance, strength, depression and fatigue at the South Australian Motion Analysis Centre. On two non-consecutive occasions, within two weeks, participants will undergo either the 6-minute walk test (6MWT) or the 6MWT while wearing a dorsiflexion ankle orthosis (with a randomised condition order). Distance walked, perceived exertion, perceived fatigue and the physiological cost of walking (the primary outcome measures) will be compared between the two walking conditions. Additional pre- and post-6MWT assessments for the two conditions will include tests of strength, reaction time, gait and balance.
DISCUSSION: This study will increase our understanding of motor fatigue on gait and balance control in
MSers and elucidate the effect of a Dynamic Ankle Orthosis on fatigue-related balance and gait in PWMS. It will also examine relationships between mobility and balance performance with perceived fatigue levels in this group.
"A publication about a planned study. Do you think it is well-designed? Would you change anything about the design? What about cost-effectiveness data? This study in the current form could not be used by NICE as it does not appear to include cost-effectiveness data. I would also want to know the impact on Dynamic Ankle Orthosis on falls and fractures. The latter is what our Commissioners' have asked us about Fampridine."