To explore the feasibility of conducting a Phase III randomized controlled trial evaluating sensory dynamic orthoses for upper limb tremor in multiple sclerosis.Design:
Mixed methods: double blind randomized placebo controlled pilot study and semi-structured interviews.Setting:
A total of 21 people with multiple sclerosis with upper limb tremor.Interventions:
Participants received a sensory dynamic orthosis sleeve or a non-compressive sleeve (placebo) that they wore eight hours a day, for nine weeks.Main measures:
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.Conclusion:
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.