Clinical trial NCT01650610: Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
Official title: Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson´s Disease
Keywords: Parkinson´s Disease
Rehabilitation
Cognition
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2012-07-26
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 02/2013 (Up to seven months)
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 02/2013 (Up to seven months)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Brazil Parkinson Association
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Cynthia B Ferrari, PhD Student
role: PRINCIPAL_INVESTIGATOR
References: