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

NCT01650610 | Unknown

• 1 other identifier: USPNEC001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson´s Disease

Keywords

Parkinson´s Disease; Rehabilitation; Cognition

Outcome Measures

Primary Outcomes (1)

• Dynamic Gait Index

  The scale assesses the ability to adapt the gait during motor tasks with different demands.

  02/2013 (Up to seven months)

Secondary Outcomes (1)

• Montreal Cognitive Assessment

  02/2013 (Up to seven months)

Study Arms (1)

Gait training executive functions tasks

EXPERIMENTAL

This group will perform a gait training associated with the tasks that require the main executive functions.

Behavioral: Gait training executive functions tasks

Interventions

Gait training executive functions tasks BEHAVIORAL

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 executive functions tasks

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

Brazil Parkinson Association

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Maria Elisa P Piemonte, PhD

  University of Sao Paulo

  STUDY DIRECTOR

• Cynthia B Ferrari, PhD Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siqueira, Ms

CONTACT

55-11-25788177; parkinson@parkinson.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 8, 2012

Record last verified: 2012-11

Locations

BR (1)