Multiple Sclerosis Clinical Trial
Official title:
The Effects of Vestibular Rehabilitation on MS-related Fatigue and Upright Postural Control: a Randomized Controlled Trial
The purpose of this study was to test the feasibility and effectiveness of a novel exercise intervention for individuals who live with multiple sclerosis (MS).
The investigators investigated the effect of a vestibular exercise program designed to help
people with MS with two common problems: fatigue and difficulties with balance while
standing and walking. Our primary aim was to compare the results from persons with MS that
participated in the vestibular exercises (Experimental group) to individuals who
participated in a more typical rehabilitation exercise program consisting of stretching and
endurance exercise (Exercise Control group) or people who did not receive exercise treatment
(Control group).
The study was a 14-week randomized controlled trial. Thirty eighty participants were
followed for four weeks before being randomly assigned to one of the three groups. Each
participant had an equal chance of being assigned to either the Experimental group, Exercise
Control group or the Control group. The Experimental group received a standardized
vestibular exercise program that included upright postural control (balance) and eye
movement exercises (6 one-hour sessions over 6 weeks). The Exercise Control group received
endurance training using a stationary bicycle and leg stretching exercises (6 one-hour
sessions over 6 weeks). Both exercise groups received the same 5 minutes of fatigue
management education. Measurements of self-reported fatigue, dizziness and depression, and
performance of a computerized, standing upright postural control test and walking capacity
test were measured to determine benefits from the interventions. Participants in the Control
group did not exercise, however if they chose, received the treatment within the clinical
setting upon completion of their participation in the study.
The investigators hypothesized that: 1) participants in the Experimental group would improve
significantly in fatigue and balance; 2) improvements found in the Experimental group would
be significantly greater than improvements in the Exercise Control group and Control group.
Results: Analyses occur at: Baseline; at 10 weeks of follow-up (Baseline to
post-intervention; and at 14 weeks of follow-up (post-intervention to post-four week
unsupervised follow-up.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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