Protocol: Mental Practice Combined With Physical Practice of Gait in Parkinson's Disease.

Parkinson Disease Clinical Trial

Official title: Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease: A Multicentre Randomized Controlled Trial Protocol

Status Not yet recruiting

Clinical Trial Summary

Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD. Thus, the aim of this study is to investigate the effects of mental gait practice associated with physical practice (PP) to improve the gait performance of PPD.

Clinical Trial Description

Background: Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD.

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: Onde hundred and forty four people living with Parkinson's disease in stages 2-3 disease evolution according to Hoehn and Yahr Classification.

Interventions: The participants will be randomly allocated in an experimental group (EG), and a control group (CG). Both groups will perform 10 individual training sessions, two individual sessions per week, for five weeks. Every session will be guided by a physiotherapist. The training sessions consist of four blocks of MP intercalated with four blocks of PP of gait in single-task (ST) and dual-task (DT) conditions. The only difference between the groups will be the content of mental practice blocks: the EG will perform mental practice of gait (GMP) while the CG will perform non-gait mental practice (nGMP).

Randomization: Participants will be randomized by ClinStat software into one of two groups:

Experimental Group (EG), which will perform the GMP; and Control Group (CG), which will perform the nGMP.

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., 7 days pre-intervention and 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. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03565965
• Study type: Interventional
• Source: University of Sao Paulo General Hospital
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2019
• Completion date: December 2019