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Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

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ClinicalTrials.gov Identifier: NCT01650623
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
Sponsor:
Collaborator:
Coordination for the Improvement of Higher Education Personnel
Information provided by (Responsible Party):
Cynthia Bedeschi Ferrari, University of Sao Paulo

Brief Summary:

The aim of this study is to compare two physical therapy training consisting of gait training that are distinguished by one being associated with tasks that require handling of the main executive functions, performed by individuals with Parkinson's Disease.

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).


Condition or disease Intervention/treatment Phase
Parkinson´s Disease Behavioral: Gait training executive functions tasks Behavioral: Gait training alone Not Applicable

Detailed Description:

The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
Study Start Date : July 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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).
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.
Active Comparator: Gait training alone
The control group will perform a gait training alone, without associated tasks (single-task condition).
Behavioral: 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.



Primary Outcome Measures :
  1. Dynamic Gait Index [ Time Frame: 05/2013 (Up to ten months) ]
    The scale assesses the ability to adapt the gait during motor tasks with different demands.


Secondary Outcome Measures :
  1. Montreal Cognitive Assessment [ Time Frame: 05/2013 (Up to ten 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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT01650623


Contacts
Contact: Siqueira, Ms 55-11-25788177 parkinson@parkinson.org.br

Locations
Brazil
Brazil Parkinson Association Recruiting
São Paulo, Brazil
Contact: Grossmann, President    55-11-25788177    parkinson@parkinson.org.br   
Principal Investigator: Cynthia B Ferrari, PhD Student         
Sponsors and Collaborators
University of Sao Paulo
Coordination for the Improvement of Higher Education Personnel
Investigators
Study Director: Maria Elisa P Piemonte, PhD University of São Paulo
Principal Investigator: Cynthia B Ferrari, PhD Student University of são Paulo

Responsible Party: Cynthia Bedeschi Ferrari, PT, Ms, PhD Student - Neuroscience and Behavior, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01650623     History of Changes
Other Study ID Numbers: USPNEC002
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012

Keywords provided by Cynthia Bedeschi Ferrari, University of Sao Paulo:
Parkinson´s Disease
Rehabilitation
Cognition

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases