Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol

Conditions
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Parkinson´s Disease

Intervention / Treatment
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* Behavioral: Gait training executive functions tasks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders; In use of dopaminergic medication; Disease severity of 1 to 3 according to Hoehn & Yahr scale; Absence of other neurological disorders or co-morbidities that may affect gait; Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE); Vision and hearing adequate or corrected to normal; Ability to walk independently; Absence of prolonged off state; Age 50 to 85 years. Exclusion Criteria: Biomechanical alterations (other pathologies) that could compromise the completion of training; Presence of depression, detected by the Geriatric Depression Scale (GDS-15); Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training; Any changes in drug treatment for PD.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait training executive functions tasks<br>This group will perform a gait training associated with the tasks that require the main executive functions. | Behavioral: Gait training executive functions tasks<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Gait Index | The scale assesses the ability to adapt the gait during motor tasks with different demands. | 02/2013 (Up to seven months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment | 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. | 02/2013 (Up to seven months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson´s Disease, Rehabilitation, Cognition