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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Sao Paulo
Sponsor:
Collaborator:
Coordination for the Improvement of Higher Education Personnel
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
  Purpose

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.


Condition Intervention
Parkinson´s Disease
Behavioral: Gait training executive functions tasks

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
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.

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).

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650610

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
  More Information

No publications provided

Responsible Party: Cynthia Bedeschi Ferrari, PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01650610     History of Changes
Other Study ID Numbers: USPNEC001
Study First Received: July 19, 2012
Last Updated: November 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by 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

ClinicalTrials.gov processed this record on August 26, 2014