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

This study is currently recruiting participants.
Verified November 2012 by University of Sao Paulo
Sponsor:
Collaborator:
Coordination for the Improvement of Higher Level Personnel (CAPES)
Information provided by (Responsible Party):
Cynthia Bedeschi Ferrari, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01650610
First received: July 19, 2012
Last updated: November 6, 2012
Last verified: November 2012

July 19, 2012
November 6, 2012
July 2012
February 2013   (final data collection date for primary outcome measure)
Dynamic Gait Index [ Time Frame: 02/2013 (Up to seven months) ] [ Designated as safety issue: No ]
The scale assesses the ability to adapt the gait during motor tasks with different demands.
Same as current
Complete list of historical versions of study NCT01650610 on ClinicalTrials.gov Archive Site
Montreal Cognitive Assessment [ Time Frame: 02/2013 (Up to seven months) ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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.

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).

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Parkinson´s Disease
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.
Experimental: Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
Intervention: Behavioral: Gait training executive functions tasks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
50 Years to 85 Years
No
Contact: Siqueira, Ms 55-11-25788177 parkinson@parkinson.org.br
Brazil
 
NCT01650610
USPNEC001
No
Cynthia Bedeschi Ferrari, University of Sao Paulo
University of Sao Paulo
Coordination for the Improvement of Higher Level Personnel (CAPES)
Study Director: Maria Elisa P Piemonte, PhD University of São Paulo
Principal Investigator: Cynthia B Ferrari, PhD Student University of São Paulo
University of Sao Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP