Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
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|ClinicalTrials.gov Identifier: NCT01650610|
Recruitment Status : Unknown
Verified November 2012 by Cynthia Bedeschi Ferrari, University of Sao Paulo.
Recruitment status was: Recruiting
First Posted : July 26, 2012
Last Update Posted : November 8, 2012
The aim of this study is the development and implementation of a new protocol of a physical therapy training, based on a gait training associated with executive tasks, for treatment of individuals with Parkinson's Disease.
The hypothesis is that this group of patients who will carry out training of this study protocol will show improvement in measured parameters (functionality of gait and cognitive ability), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson´s Disease||Behavioral: Gait training executive functions tasks||Not Applicable|
The aim of this study is the development and implementation of a new protocol of physical therapy training, based on a gait training associated with executive tasks for treatment of individuals with Parkinson's Disease.
The proposed motor training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and after this, 30 minutes of gait training in a dual-task condition, associated with distracting tasks that require handling of the main executive functions.
It will be an open label study, non 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. 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||July 2013|
Experimental: Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
Behavioral: Gait training executive functions tasks
The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
- Dynamic Gait Index [ Time Frame: 02/2013 (Up to seven months) ]The scale assesses the ability to adapt the gait during motor tasks with different demands.
- Montreal Cognitive Assessment [ Time Frame: 02/2013 (Up to seven months) ]This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650610
|Contact: Siqueira, Msfirstname.lastname@example.org|
|Brazil Parkinson Association||Recruiting|
|São Paulo, Brazil|
|Contact: Grossmann, President 55-11-25788177 email@example.com|
|Principal Investigator: Cynthia B Ferrari, PhD Student|
|Study Director:||Maria Elisa P Piemonte, PhD||University of São Paulo|
|Principal Investigator:||Cynthia B Ferrari, PhD Student||University of São Paulo|