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

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:
NCT01650623
First received: July 19, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Dynamic Gait Index [ Time Frame: 05/2013 (Up to ten 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: 05/2013 (Up to ten 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: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Level Personnel (CAPES)
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, PT, Ms, PhD Student - Neuroscience and Behavior, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01650623     History of Changes
Other Study ID Numbers: USPNEC002
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 April 22, 2014