title: Sensory dynamic orthoses in mild to moderate upper limb tremor in multiple sclerosis: a mixed methods feasibility study.
abstract: OBJECTIVE
  To explore the feasibility of conducting a Phase III randomized controlled trial evaluating sensory dynamic orthoses for upper limb tremor in multiple sclerosis.
  
  
  METHODS
  Mixed methods: double blind randomized placebo controlled pilot study and semi-structured interviews.
  
  
  METHODS
  Rehabilitation centre.
  
  
  METHODS
  A total of 21 people with multiple sclerosis with upper limb tremor.
  
  
  METHODS
  Participants received a sensory dynamic orthosis sleeve or a non-compressive sleeve (placebo) that they wore eight hours a day, for nine weeks.
  
  
  METHODS
  Outcomes were completed at baseline and nine weeks. The primary outcome measure was the Fahn-Tolosa-Marin (FAHN) Tremor Rating Scale. Secondary outcome measures included the: Action Research Arm Test, Canadian Occupational Performance Measure, Psychological Impact of Assistive Device Scale and the Nine-hole Peg Test.
  
  
  RESULTS
  Both sleeves were acceptable, although achieving a good fit was an issue. There were no significant between-group differences for the primary outcome measure. The median ± interquartile range change scores were 0.5 ±6.5 and 2 ±8 for the placebo and treatment group, respectively. The median ± interquartile range Canadian Occupational Performance Measure (performance subscale) demonstrated significant improvements ( p = 0.01) for the placebo group (1.1 ±1.65) compared with the treatment group (0 ±1.2). There was no between-group differences in the satisfaction subscale. The primary outcome measure was sensitive to detect change; however the Action Research Arm Test was not responsive in this study population.
  
  
  CONCLUSIONS
  Undertaking an randomized controlled trial would be feasible and a minimum of 200 participants would be needed for a fully powered, definitive randomized controlled trial.
authors.affiliation: 1 NHS Ayrshire & Arran MS Service, Douglas Grant Rehabilitation Unit, Irvine, UK.|2 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
authors.forename: L
authors.initials: L
authors.lastname: Miller
authors.affiliation: 2 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
authors.forename: F
authors.initials: F
authors.lastname: van Wijck
authors.affiliation: 1 NHS Ayrshire & Arran MS Service, Douglas Grant Rehabilitation Unit, Irvine, UK.
authors.forename: L
authors.initials: L
authors.lastname: Lamont
authors.affiliation: 1 NHS Ayrshire & Arran MS Service, Douglas Grant Rehabilitation Unit, Irvine, UK.|2 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
authors.forename: J
authors.initials: J
authors.lastname: Preston
authors.affiliation: 3 Independent Statistics Consultant, Paisley, UK.
authors.forename: M
authors.initials: M
authors.lastname: Hair
mesh_terms: D000328:Adult; D000368:Aged; D002170:Canada; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000150:complications / Q000175:diagnosis* / Q000534:rehabilitation*; D010865:Pilot Projects; D012720:Severity of Illness Index; D013165:Splints / Q000706:statistics & numerical data*; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D014202:Tremor / Q000209:etiology / Q000534:rehabilitation*; D034941:Upper Extremity
keywords: Multiple sclerosis; activity limitation; ataxia; orthoses; upper extremity (arm)