Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
NCT ID: NCT01650610
Last Updated: 2012-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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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 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).
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
85 Years
ALL
No
Sponsors
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Coordination for the Improvement of Higher Education Personnel
OTHER
University of Sao Paulo
OTHER
Responsible Party
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Cynthia Bedeschi Ferrari
PhD Student
Principal Investigators
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Maria Elisa P Piemonte, PhD
Role: STUDY_DIRECTOR
University of Sao Paulo
Cynthia B Ferrari, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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Brazil Parkinson Association
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Grossmann, President
Role: primary
Other Identifiers
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USPNEC001
Identifier Type: -
Identifier Source: org_study_id