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

Parkinson´s Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650610
• Other study ID #: USPNEC001
• 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: February 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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.

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.	02/2013 (Up to seven 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.	02/2013 (Up to seven months)	No