Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
NCT ID: NCT01650623
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 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).
Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Gait training executive functions tasks
The experimental group will perform a gait training associated with the tasks that require the main executive functions (dual-task condition).
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.
Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
Gait training alone
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 alone, without other tasks.
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.
Gait training alone
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 alone, without other tasks.
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
PT, Ms, PhD Student - Neuroscience and Behavior
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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USPNEC002
Identifier Type: -
Identifier Source: org_study_id