Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Dynamic Gait Index
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Dynamic Gait Index
时间窗: 02/2013 (Up to seven months)
The scale assesses the ability to adapt the gait during motor tasks with different demands.
次要结局
- Montreal Cognitive Assessment(02/2013 (Up to seven months))
研究者
Cynthia Bedeschi Ferrari
PhD Student
University of Sao Paulo