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

Parkinson´s Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650623
• Other study ID #: USPNEC002
• Status: Recruiting
• Phase: N/A
• First received: July 19, 2012
• Last updated: November 6, 2012
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2012
• Source: University of Sao Paulo
• Contact: Siqueira, Ms
• Phone: 55-11-25788177
• Email: parkinson[@]parkinson.org.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson´s Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Brazil Parkinson Association	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Coordination for the Improvement of Higher Education Personnel

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Gait Index	The scale assesses the ability to adapt the gait during motor tasks with different demands.	05/2013 (Up to ten months)	No
Secondary	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)	No