Parkinson´s Disease Clinical Trial
Official title:
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
The aim of this study is to compare two physical therapy training consisting of gait
training that are distinguished by one being associated with tasks that require handling of
the main executive functions, performed by individuals with Parkinson's Disease.
The investigators hypothesis is that the experimental group (EG), which hold gait training
with higher cognitive demands (dual-task condition), will make improvements in the
parameters measured (functionality of gait and cognitive ability) to a greater extent
compared to the control group (CG), which hold gait training without executive tasks
(single-task condition).
The aim of this study is to compare two physical therapy training consisting of a gait
training that are distinguished by one being associated with tasks that require handling of
the main executive functions (protocol designed by the same team), performed by individuals
with Parkinson's Disease.
Both training consists of 30 minutes of global exercises that involves stretching, muscle
strengthen and axial mobility exercises, with the following difference:
- the experimental group (EG) will hold another 30 minutes of gait training in a
dual-task condition associated with distracting tasks that require handling of the main
executive functions;
- the control group (CG) will hold an additional 30 minutes of gait training without
associated tasks.
It will be a prospective study, single blind, randomized, where 30 patients with PD in
stages 1 to 3 on Hoehn & Yahr scale will participate in the study, to be held in Brazil
Parkinson Association. Patients will be randomized into an experimental and control group,
15 in each one.
The training will consist of 10 sessions, two times per week for five weeks. The executive
tasks concomitant with gait training cover the following executive functions: volition,
self-awareness, planning, response inhibition, response monitoring and attention.
The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive
Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating
Scale (UPDRS) and (5) Falls Efficacy Scale (FES).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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