Gait Training Associated With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Randomised Controlled Trial
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 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).
详细描述
The aim of this study is to compare two physical therapy training consisting of a gait training that are distinguished by one being associated with tasks that require handling of the main executive functions (protocol designed by the same team), performed by individuals with Parkinson's Disease.
Both training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, with the following difference:
- the experimental group (EG) will hold another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions;
- the control group (CG) will hold an additional 30 minutes of gait training without associated tasks.
It will be a prospective study, single blind, 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. Patients will be randomized into an experimental and control group, 15 in each one.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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: 05/2013 (Up to ten months)
The scale assesses the ability to adapt the gait during motor tasks with different demands.
次要结局
- Montreal Cognitive Assessment(05/2013 (Up to ten months))
研究者
Cynthia Bedeschi Ferrari
PT, Ms, PhD Student - Neuroscience and Behavior
University of Sao Paulo