Sensory dynamic orthoses in mild to moderate upper limb tremor in multiple sclerosis: a mixed methods feasibility study

L. Miller, F. van Wijck, L. Lamont, J. Preston, M. Hair

Research output: Contribution to journalArticle

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.
Design: Mixed methods: double blind randomized placebo controlled pilot study and semi-structured interviews.
Setting: Rehabilitation centre.
Subjects: 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.
Original languageEnglish
Pages (from-to)1060-1073
Number of pages14
JournalClinical Rehabilitation
Volume30
Issue number11
Early online date22 Sep 2015
DOIs
Publication statusPublished - 1 Nov 2016

Keywords

  • multiple sclerosis
  • orthosis
  • upper limb
  • symptoms

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