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

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

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).

Study Overview

• Status: Unknown
• Conditions: Parkinson´s Disease
• Intervention / Treatment: Behavioral: Gait training executive functions tasks; Behavioral: Gait training alone

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Recruiting
    • Brazil Parkinson Association
    • Contact: Grossmann, President; Phone Number: 55-11-25788177; Email: parkinson@parkinson.org.br
    • Principal Investigator: Cynthia B Ferrari, PhD Student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index	The scale assesses the ability to adapt the gait during motor tasks with different demands.	05/2013 (Up to ten months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment	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.	05/2013 (Up to ten months)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Collaborators: Coordination for the Improvement of Higher Education Personnel
• 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: July 1, 2012
• Primary Completion (Anticipated): May 1, 2013
• Study Completion (Anticipated): July 1, 2013

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 23, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: November 6, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Rehabilitation; Cognition; Parkinson´s Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: USPNEC002