Article

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.

Langue : ANGLAIS