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

Not Applicable

• Conditions: Parkinson´s Disease
• Interventions: Behavioral: Gait training alone; Behavioral: Gait training executive functions tasks

• Registration Number: NCT01650623
• Lead Sponsor: 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).

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-26
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-06
• Last Update Posted: 2012-11-08
• Primary Completion: 2013-05
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait training alone	Gait training alone	The control group will perform a gait training alone, without associated tasks (single-task condition).
Gait training executive functions tasks	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).

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Montreal Cognitive Assessment	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.

Trial Locations

Locations (1)

Brazil Parkinson Association; 🇧🇷 São Paulo, Brazil