跳至主要内容
临床试验/NCT03439800
NCT03439800Unknown不适用

Effects of Motor Imagery and Action Observation Training on Gait and Brain Activation Pattern of Individuals With Parkinson's Disease: Randomized Controlled Clinical Trial

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2018年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
Velocity

研究概览

简要总结

INTRODUCTION: Mental practice (MP) and action observation (AO) are characterized as cognitive strategies that contribute to motor planning and learning in diverse populations. Individuals with Parkinson's Disease (PD) are recent targets, since, with disease progression, they need external strategies to aid in motor organization. However, there is still no evidence of the efficacy of MP and AO in the gait of PD. OBJECTIVES: To compare the effects of physical practice preceded by MP and AO on gait performance in individuals with Idiopathic PD (IPD). METHODS: A controlled, randomized, single-blind clinical trial with 66 individuals with IPD, aged between 50 and 75 years, without cognitive deficit and in the moderate phase of the disease will be performed. For the inclusion and characterization of the sample, the following instruments / equipment will be used: (1) Identification form (sociodemographic, clinical and anthropometric aspects); (2) Mini Mental State Examination and Montreal Cognitive Assessment (cognitive level); (3) Hoehn and Yahr Scale (level of physical disability); (4) Revised Movement Imagery Questionnaire (sharpness of the mental image); (5) Qualisys Motion Capture Systems® (gait kinematics); (6) Emotiv Epoc + (electroencephalographic activity); (7) Unified Parkinson's Disease Rating Scale - UPDRS (motor function and activities of daily living); (8) Timed Up and Go Test - TUG Test (mobility); and (9) Parkinson's Disease Questionnaire - PDQ-39 (quality of life).Participants included will be randomly assigned to two groups: experimental (n = 33), who will participate in MP + AO and physical gait practice; and control group (n = 33), who will participate only in the physical practice of gait. Both groups will be submitted to 12 training sessions (3x / week, for 4 weeks) and will be reevaluated 10 minutes, 7 days and 30 days after the last training session with respect to items (4), (5), (6) and (8) of the evaluation. Primary outcomes will be velocity, stride length and range of motion of the hip and the secondary ones will be sharpness of the mental image, electroencephalographic activity and performance in the TUG Test. The normality in the data distribution will be verified through the Shapiro-Wilk test. The "t" test and the Mann-Whitney test will be used to verify the homogeneity of the groups in the baseline. A repeated measures ANOVA will verify the interaction between the groups at the moments observed.

详细描述

No additional information.

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
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PD according to the report of a neurologist;
  • Age between 50 and 75 years;
  • In the moderate stage of the disease (between stages 2 and 3 of the Hoehn and Yahr Scale);
  • Use of antiparkinsonian medication;
  • Do not present cognitive deficits, according to the Mini Mental State Examination - MMSE. The cutoff point will be defined considering the individual's schooling (Illiterates: 18; With school instruction: 24);
  • Ability to imagine motor acts in kinesthetic mode (according to the Revised Movement Imagery Questionnaire - MIQ-R). The cut-off point will be 20 for the kinesthetic modality, indicating that it is at least "a little easy to feel" the kinesthetically imagined movement;
  • Have not undergone stereotaxic surgery.

排除标准

  • Individuals with other associated neurological diseases;
  • Individuals with musculoskeletal disorders, not related to the disease, but that impair gait;
  • Individuals with hemodynamic instability before or during training;
  • Individuals with uncorrected visual or auditory changes;
  • Individuals who do not understand some stage of the training protocol.

研究组 & 干预措施

Mental and Physical Practice

Experimental

Action observation: is defined as the observation of the motor action, in this study, through a video.

Mental Practice: is defined as motor imagery training with the aim of improving the engine performance. Is the imagination of a motor action without its physical implementation.

Physical Practice: is the execution of the motor action.

干预措施: Mental and Physical Practice (Other)

Physical Practice

Active Comparator

Physical Practice: is the execution of the motor action.

干预措施: Physical Practice (Other)

结局指标

主要结局

Velocity

时间窗: Change from Baseline Velocity at 1 day, 7 days and 30 days after training sessions

Gait velocity in meters/second evaluated with Qualisys Motion Capture System

次要结局

  • Electroencephalographic activity(Change from Baseline Electroencephalographic activity at 1 day, 7 days and 30 days after training sessions)
  • Mobility(Change from Baseline Mobility at 1 day, 7 days and 30 days after training sessions)
  • Stride length(change from Baseline Stride length at 1 day, 7 days and 30 days after training sessions)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Raquel Rodrigues Lindquist

PhD

Universidade Federal do Rio Grande do Norte

研究点 (2)

Loading locations...

相似试验