- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01650610
Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Siqueira, Ms
- Phone Number: 55-11-25788177
- Email: parkinson@parkinson.org.br
Study Locations
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-
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São Paulo, Brazil
- Recruiting
- Brazil Parkinson Association
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Contact:
- Grossmann, President
- Phone Number: 55-11-25788177
- Email: parkinson@parkinson.org.br
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Principal Investigator:
- Cynthia B Ferrari, PhD Student
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
02/2013 (Up to seven months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
02/2013 (Up to seven months)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Maria Elisa P Piemonte, PhD, University of Sao Paulo
- Principal Investigator: Cynthia B Ferrari, PhD Student, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USPNEC001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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