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

NCT01650623 | Unknown

• 1 other identifier: USPNEC002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

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.

  05/2013 (Up to ten months)

Secondary Outcomes (1)

• Montreal Cognitive Assessment

  05/2013 (Up to ten months)

Study Arms (2)

Gait training executive functions tasks

EXPERIMENTAL

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

Gait training alone

ACTIVE COMPARATOR

The control group will perform a gait training alone, without associated tasks (single-task condition).

Behavioral: Gait training alone

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

Gait training alone 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 alone, without other tasks.

Gait training alone

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Ms, PhD Student - Neuroscience and Behavior

Study Record Dates

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

Record last verified: 2012-11

Locations

BR (1)