Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Parkinson´s Disease |
Behavioral: Gait training executive functions tasks |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol |
- Dynamic Gait Index [ Time Frame: 02/2013 (Up to seven months) ] [ Designated as safety issue: No ]The scale assesses the ability to adapt the gait during motor tasks with different demands.
- Montreal Cognitive Assessment [ Time Frame: 02/2013 (Up to seven months) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Gait training executive functions tasks
This group will perform a gait training associated with the tasks that require the main executive functions.
|
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.
|
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| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Siqueira, Ms | 55-11-25788177 | parkinson@parkinson.org.br |
| 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 | |
| Study Director: | Maria Elisa P Piemonte, PhD | University of São Paulo |
| Principal Investigator: | Cynthia B Ferrari, PhD Student | University of São Paulo |
More Information
No publications provided
| Responsible Party: | Cynthia Bedeschi Ferrari, PhD Student, University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT01650610 History of Changes |
| Other Study ID Numbers: | USPNEC001 |
| Study First Received: | July 19, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 22, 2013