Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease
研究概览
详细说明
Background: Among the impairments associated to Parkinson's disease, the gait disturbance is one of which that has the most negative impact on the independence in daily living activities and quality of life of people living with Parkinson's disease. Despite the considerable amount of research, we have no consensus about the most efficient physiotherapeutic approach to improve the gait disturbance. Mental practice is considered an efficient strategy to improve the motor performance in healthy individuals and people with stroke. However, there is scarce evidence about its therapeutic results to improve the gait performance in people living with Parkinson's disease.
Objectives: To investigate the effects of mental gait practice associated with physical practice to improve the gait performance of people living with Parkinson's disease.
Design: Parallel, prospective, double-blind, multicentre randomized clinical trial.
Setting: Brazilian Parkinson Association.
Participants: Twenty-two people living with Parkinson's disease in stages 2-3 of disease evolution according to Hoehn and Yahr Classification.
Interventions: The participants will be randomly allocated in an experimental group and a control group. Both groups will perform 10 individual training sessions, two times per week, for five weeks. The training sessions consist of four blocks of mental practice intercalated with four blocks of physical practice of gait under different conditions. The only difference between the groups will be the content of mental practice blocks: the experimental group will perform mental practice of gait while the control group performs non-gait mental practice.
Randomization: Participants will be randomized by ClinStat software into one of two groups: Experimental Group (EG), which will perform gait mental practice; and Control Group (CG), which will perform the non-gait mental practice.
Statistical analysis: The training effects for each primary and secondary outcome measure will be analyzed for the two training conditions (i.e., control and experimental) at the four assessment time points (i.e., pre-intervention, 7 days post-completion and at 30 and 60-day follow-up) using a mixed-design ANOVA with training as the between-group factor and the assessment time point as the within-group factor. The effect sizes (ES) will be calculated for all comparisons at alpha = 0.05. A Tukey HSD post-hoc test will be used for multiple comparisons and p-values below 5 % will be considered as statistically significant.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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São Paulo、巴西、04142-092
- Brazil Parkinson Association
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria;
- in stage 2-3 of the disease evolution according to the Hoehn and Yahr;
- treated with levodopa or its synergists;
- capable to walk independently indoors without aid;
- referring 5 years of education or more.
Exclusion Criteria:
- presence of other neurological (excluding PD), orthopedic or cardiopulmonary problems;
- visual and auditory deficiency uncorrected;
- dementia [assessed by Montreal Cognitive Assessment (MoCA), cut-off 26];
- depression [according to the Geriatric Depression Scale (GDS-15), cut-off 6];
- declined imagery capacity [according to the Revised Movement Imagery Questionnaire (MIQ-R) cut-off 10].
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：实验组（EG）
实验训练 (ET) 包括 10 个会话，在单任务 (ST) 和双任务 (DT) 条件下，4 个 MP (GMP) 块插入 4 个步态物理练习 (GPP) 块。
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每个 MP 块包含 5 次心理行走尝试和 10 个想象的步骤。 参与者舒适地坐着，闭上眼睛，将被要求想象自己以第一人称视角行走，没有任何明显的身体运动，在四种不同的情况下：习惯速度、尽可能快、克服障碍和记住一个名字具体用药。 每个 PP 块包含 5 次物理步行尝试，共 10 步。 参与者将被要求在 4 种不同的条件下行走：习惯速度、尽可能快、克服障碍和记住特定药物的名称。 |
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有源比较器：Control Group
The Control training (CT) consists of 10 sessions with 4 blocks of MP (nGMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.
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每个 MP 块包含 5 次心理行走尝试和 10 个想象的步骤。 参与者舒适地坐着，闭上眼睛，将被要求想象自己坐着欣赏美丽的风景，作为第一人称视角，没有任何明显的身体运动，在四种不同的环境中：在马车里，在热气球里，在船和齐柏林飞艇。 每个 PP 块包含 5 次物理步行尝试，共 10 步。 参与者将被要求在 4 种不同的条件下行走：习惯速度、尽可能快、克服障碍和记住特定药物的名称。 |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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六分钟步行测试
大体时间：长达 3 个月
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六分钟步行测试 (6-MWT) 是一项基于临床推荐的定时测试，要求参与者以习惯的速度步行 6 分钟，距离越远越好。
如有必要，允许中断休息。
6-MWT 已证明足够的重测和评估者间可靠性以及 82 米 PD 的最小可检测变化。
它可能是一个很好的独立安全行走能力的预测指标。
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长达 3 个月
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Postural Instability and Gait Difficulty Score
大体时间：up to 3 months
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Postural Instability and Gait Difficulty Score (PIGD): This recommended rating scale for evaluation of gait alterations in PD is based on 5 Unified Parkinson's Disease Rating Scale (UPDRS) items relevant to gait and postural instability (items 13-15, 29, and 30).
The 13-15 items are based on gait performance according to PPD perspective, while 29 and 30 items are based on the motor test.
It is a recent rating scale that has been used in PD, evaluated independently, which has adequate clinimetric characteristics.
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up to 3 months
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Dynamic Gait Index
大体时间：up tp 3 months
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The balance during the eight gait related activities is scored in this test.
These include quality of walking speed change, going around and over obstacles and stair walking, as well as the number of steps required for a pivot turn.
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up tp 3 months
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30-second dual task gait
大体时间：up tp 3 months
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It measures the maximal walking distance reached in 30 seconds under single task, i.e., without another concurrent task, and dual task, i.e., with a concurrent cognitive task.
The cognitive task consists of speaking as many words as possible, starting with a specific character (F, S or A), presented at the beginning of test.
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up tp 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Trail Making Test
大体时间：up to 3 months
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This test is constituted with two-timed parts: Part A, which involves a visual-scanning task where the participant is required to draw lines sequentially connecting consecutively numbered circles (1-25) randomly arranged on a page as fast as possible.
Part B, which assesses cognitive flexibility, where the participant is asked to connect the same number of circles in an alternating sequence of numbers and letters (1, A, 2, B, etc.).
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up to 3 months
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39-item Parkinson's Disease Questionnaire
大体时间：up to 3 months
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This scale assesses the health-related quality of life, i.e., the impact of an illness and/or treatment on patients' perception of their status of health and on subjective well-being or satisfaction with life.
It evaluates 39 parameters in eight groups of issues (mobility, ADL, emotional well-being, stigma of the disease, back in the next, cognitive, communication and bodily discomfort).
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up to 3 months
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合作者和调查者
调查人员
- 首席研究员：Maria Elisa P Piemonte, PhD、Department of Physioterapy , Communication Science&Disorders, Occupational Therapy, School of Medicine, University of São Paulo
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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