Parkinson's Disease Clinical Trial
Official title:
Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
The purpose of this study is to investigate whether the beneficial effect of treadmill training on people with Parkinson's disease can be enhanced by high- and low-frequency repetitive transcranial magnetic stimulation (rTMS).
This is a randomised placebo-controlled trial. Fifty-one participants with Parkinson's
disease (PD) will be recruited from the Hong Kong PD association, a self-help group and
movement disorders clinic of 3 local hospitals. Written informed consent in accordance with
the Declaration of Helsinki will be obtained from all participants. Eligible participants
will be randomly assigned into one of the three groups: 1Hz-TT, 25Hz-TT, and sham-TT upon
recruitment. Randomisation will be generated by a computer program and group assignment will
be blinded to both participants and assessor. Participant will receive either 1-Hz, 25-Hz, or
sham rTMS which will last for about 20 minutes followed by 30 minutes treadmill walking
training for 12 sessions, 4 times per week for 3 weeks. All assessments will be conducted 1
week before intervention and 1 day after completion of intervention, after 1-month training
and at 3-month post training.
The sample size calculation is based on the significant findings of the gait speed reported
by Yang et al (2013). A two-way repeated measures ANOVA design with between-subject group
effect (3 levels) and within-subject time effect (4 levels) determines that 15 subjects per
group are required to achieve 85% power to test the interaction effect between groups and
time effect with a 5% significance level and the effect size is 0.2. By assuming 10% dropout
rate, 17 subjects will be required per group.
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