Parkinson Disease Clinical Trial
Official title:
Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
Among the impairments associated to Parkinson's disease, gait disturbance is one of which that has the most negative impact on the independence in daily living activities and quality of life of people living with Parkinson's disease. Despite the considerable amount of research, we have no consensus about the most efficient physiotherapeutic approach to improve the gait disturbance. Mental practice is considered an efficient strategy to improve the motor performance in healthy individuals and people with stroke. However, there is scarce evidence about its therapeutic results to improve the gait performance in people living with Parkinson's disease. Thus, the aim of this study is to investigate the effects of gait mental practice associated to physical practice to improve the gait performance in people living with Parkinson's disease.
Background: Among the impairments associated to Parkinson's disease, the gait disturbance is
one of which that has the most negative impact on the independence in daily living activities
and quality of life of people living with Parkinson's disease. Despite the considerable
amount of research, we have no consensus about the most efficient physiotherapeutic approach
to improve the gait disturbance. Mental practice is considered an efficient strategy to
improve the motor performance in healthy individuals and people with stroke. However, there
is scarce evidence about its therapeutic results to improve the gait performance in people
living with Parkinson's disease.
Objectives: To investigate the effects of mental gait practice associated with physical
practice to improve the gait performance of people living with Parkinson's disease.
Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.
Setting: Brazilian Parkinson Association.
Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease
evolution according to Hoehn and Yahr Classification.
Interventions: The participants will be randomly allocated in an experimental group and a
control group. Both groups will perform 10 individual training sessions, two times per week,
for five weeks. The training sessions consist of four blocks of mental practice intercalated
with four blocks of physical practice of gait under different conditions. The only difference
between the groups will be the content of mental practice blocks: the experimental group will
perform mental practice of gait while the control group performs non-gait mental practice.
Randomization: Participants will be randomized by ClinStat software into one of two groups:
Experimental Group (EG), which will perform gait mental practice; and Control Group (CG),
which will perform the non-gait mental practice.
Statistical analysis: The training effects for each primary and secondary outcome measure
will be analyzed for the two training conditions (i.e., control and experimental) at the four
assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day
follow-up) using a mixed-design ANOVA with training as the between-group factor and the
assessment time point as the within-group factor. The effect sizes (ES) will be calculated
for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple
comparisons and p-values below 5 % will be considered as statistically significant.
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