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

• ClinicalTrials.gov Identifier: NCT01650623
• Recruitment Status: Unknown
• First Posted: July 26, 2012
• Last Update Posted: November 8, 2012
• Sponsor: University of Sao Paulo
• Collaborator: Coordination for the Improvement of Higher Education Personnel
• Information provided by (Responsible Party): Cynthia Bedeschi Ferrari, University of Sao Paulo

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Parkinson´s Disease	Behavioral: Gait training executive functions tasks; Behavioral: Gait training alone	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
• Study Start Date: July 2012
• Estimated Primary Completion Date: May 2013
• Estimated Study Completion Date: July 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Montreal Cognitive Assessment [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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 Education Personnel

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

• Responsible Party: Cynthia Bedeschi Ferrari, PT, Ms, PhD Student - Neuroscience and Behavior, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01650623
• Other Study ID Numbers: USPNEC002
• First Posted: July 26, 2012
• Last Update Posted: November 8, 2012
• Last Verified: November 2012

Keywords provided by Cynthia Bedeschi Ferrari, 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