Mental Practice Combined With Physical Practice to Improve the Gait Performance of People With Parkinson's Disease: A Multicentre Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Six-minute Walk Test
研究概览
简要总结
Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD. Thus, the aim of this study is to investigate the effects of mental gait practice associated with physical practice (PP) to improve the gait performance of PPD.
详细描述
Background: Among the impairments associated with Parkinson's disease (PD), gait disturbance is one of the most injurious to the independence in daily living activities and the quality of life of people living with Parkinson's disease (PPD). Despite a considerable amount of research, there is no consensus about the most efficient physiotherapeutic approach to improve gait disturbance. Mental practice (MP) is considered an efficient strategy to improve the motor performance of healthy individuals and people with stroke. However, there is little evidence about its therapeutic results as a tool to improve gait performance in PPD.
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: Onde hundred and forty four people living with Parkinson's disease in stages 2-3 disease evolution according to Hoehn and Yahr Classification.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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].
研究组 & 干预措施
Experimental Group (EG)
The Experimental training (ET) consists of 10 sessions with 4 blocks of MP (GMP) intercalated with 4 blocks of gait physical practice (GPP), under single (ST) and dual-task (DT) conditions.
干预措施: Experimental training (Behavioral)
Control Group (CG)
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.
干预措施: Control training (Behavioral)
结局指标
主要结局
Six-minute Walk Test
时间窗: up to 3 months
The six-minute walk test (6-MWT) is a timed recommended clinically based test in which participants are asked to walk for 6 minutes, in their habitual speed, as much distance as possible. Interruptions for resting are permitted if necessary. The 6-MWT has demonstrated adequate test-retest and interrater reliability and minimal detectable change of 82 meters in PD. It may be a good predictor of the ability to independently walk outside safely.
Dynamic Gait Index
时间窗: up to 3 months
The Dynamic Gait Index (DGI) is a test that assess gait balance. It has demonstrated good feasibility, test-retest, interrater reliability and minimal detectable change of 3-point reduction in PD. Furthermore, it is considerable as a supportive test for identifying the fall risk in people with PD. 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. The performance is scored from 0 to 3, with 0 indicating the lowest and 24 the highest level of functioning.
Postural Instability and Gait Difficulty Score
时间窗: up to 3 months
The Postural Instability and Gait Difficulty Score (PIGD) is a recommended rating scale for evaluation of gait alterations in PD 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.
30 seconds DT gait
时间窗: up to 3 months
The 30 seconds DT gait (30sDTG) is a test in which measures the maximal walking distance reached in 30 seconds under single and dual taks. 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. This cognitive task showed to be more sensitive for dual task impairment and less prone to education level.
Functional Near Infrared Spectroscopy (fNIS)
时间窗: up tp 3 months
During 30sDTG, the concentration of oxygenated and deoxygenated hemoglobin of the motor and prefrontal regions will be measured. The measuring cap based on the 10-20 international will be set to acquire signal from primary motor cortices and dorsolateral prefrontal cortices. Data will be modelled based on the onset gait time for 30s, automatically defined by trigger markers. The onset and duration of each condition will be convolved with the canonical hemodynamic response function to obtain the regressors. The individual and group measures comparisons, considering the condition with and without dual task will be performed with a significance level of 5%.
次要结局
- Trail Making Test(up to 3 months)
- 39-item Parkinson's Disease Questionnaire(up to 3 months)