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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01650610
Enrollment
30
Registered
2012-07-26
Start date
2012-07-31
Completion date
2013-07-31
Last updated
2012-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson´s Disease

Keywords

Parkinson´s Disease, Rehabilitation, Cognition

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.

Detailed 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).

Interventions

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.

Sponsors

Coordination for the Improvement of Higher Education Personnel
CollaboratorOTHER
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Dynamic Gait Index02/2013 (Up to seven months)The scale assesses the ability to adapt the gait during motor tasks with different demands.

Secondary

MeasureTime frameDescription
Montreal Cognitive Assessment02/2013 (Up to seven 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.

Countries

Brazil

Contacts

Primary ContactSiqueira, Ms
parkinson@parkinson.org.br55-11-25788177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026