跳至主要内容
临床试验/NCT05696925
NCT05696925已完成不适用

Effects of Motor Imagery and Action Observation on Upper Limb Motor Chances and Cognitive Chances in Parkinson's Disease: Randomized Clinical Trial

Federal University of Health Science of Porto Alegre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Parkinson's Disease-Cognitive Rating Scale

研究概览

简要总结

Parkinson's disease is degenerative, progressive, and chronic. It is considered potentially disabling, in view of the motor alterations, such as bradykinesia, rigidity, and tremor in the upper limbs, and non-motor alterations, such as cognitive ones involving attention, concentration and memory difficulties. Thus, neurorehabilitation modalities, such as motor imagery and action observation, have been used. The aim of this research is to investigate the effects of motor imagery and action observation on upper limb motor and cognitive changes in Parkinson's disease. This is a randomized controlled trial type study. The population of the study involves people with Parkinson's disease in stages 1-3 on the Hoehn and Yahr scale, aged 20 to 80 years, who must be on stable medication, have no cognitive impairment with risk of dementia, be able to imagine motor activities and have upper limb motor impairment. The study groups will be: a) motor imagery, observation of action and motor execution; b) motor imagery and motor execution; c) observation of action and motor execution; d) motor imagery and motor execution and exoskeleton; e) observation of action and motor execution and exoskeleton. The interventions of all groups will be an intensive approach of 10 continuous sessions, with a two-day break in the middle of the intervention, totaling two weeks, with each session lasting 40 minutes a day. The data collection steps for the study will involve the pre-test, the interventions, the immediate post-test, and the test after a four-week period without intervention. The instruments that will be used for the evaluations will be: a) part of the Unified Parkinson's Disease Rating Scale (UPDRS-III); b) Test D'évaluation Des Membres Supérieurs Des Personnes Âgées (TEMPA); c) 9-Hole Peg Test to assess upper extremity function; d) Parkinson's Disease Cognitive Assessment Scale; e) Canadian Occupational Performance Measure to identify performance and satisfaction in performing activities in the areas of self-care, productivity, and leisure.

详细描述

Parkinson's disease (PD) is degenerative, occurs slowly and progressively, is idiopathic, and involves several factors. In PD occurs the degeneration of dopamine-producing neurons (dopaminergic neurons) in the substantia nigra, within the basal ganglia. The activation of excitatory neurons then occurs, manifesting itself through the dysregulation of motor control.

PD is characterized by non-motor and motor symptoms, being causes of negative implications in quality of life, reflecting directly in several daily situations of the person with PD. Non-motor symptoms are considered as additional symptoms and are also frequent, having the prevalence of dementia and mild cognitive impairment. The most observed cognitive problems in PD are in the following domains: concentration and attention, working memory, as well as difficulties with calculations and spatial orientation activities, and executive functions. The non-motor symptoms have a negative impact on occupational performance, and may present difficulties in activities such as driving, shopping, household maintenance; as well as self-care: dressing and bathing.

The main motor symptoms are: a) resting tremor - occurs at rest and decreases when voluntary movement is attempted; b) rigidity - simultaneous increase in muscle tone, which may present a constant resistance throughout the range of motion when the movement is slow and progressive or a rhythmically resisted movement throughout the range of motion; c) akinesia - difficulty to initiate movement; d) bradykinesia - slowness to maintain movement.

The tremor in PD is an involuntary rhythmic movement, typically characterized by unilateral resting tremor, which occurs in the upper extremities, especially the hands. Resting tremor is inhibited during movement and may reappear as frequently when adopting a posture or even when moving. The essential tremor occurs more in the forearms and hands, being more problematic during voluntary movement or when maintaining the posture against gravity, which affects the performance of activities of daily living, and the most affected are: writing by hand, eating, dressing, and taking care of oneself. There are also isolated postural and kinetic tremors, with an even higher frequency (greater than 4 Hz).

In turn, rigidity is one of the cardinal symptoms of PD and includes information on severity, distribution, and whether it is present at rest and in a non-drug state. People with PD have higher rigidity values, both at rest and during passive mobilization, because there is an increased tone in the muscles. Reduced range of motion can be a debilitating consequence of PD, affecting daily activities such as writing. Regarding bradykinesia, it refers to the difficulty of adjusting body position, initiating and executing movement, and performing sequential and simultaneous movements.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •have a diagnosis of Parkinson's disease and be in stage 1-3, consistent with a mild and moderate disability;
  • •be aged between 20 years old to 80 years old;
  • •be on stable use of medication;
  • •no dementia;
  • •be minimally capable of imagining motor activities;
  • •present motor alteration in the dominant upper limb;
  • •have signed the Informed Consent Form.

排除标准

  • •not present additional central nervous system disorders or other conditions that may affect upper and lower extremity function;
  • •present with other uncontrolled chronic conditions that may interfere with the participant's safety.

研究组 & 干预措施

motor imagery and execution of the action (GE2)

Experimental

in the sitting position, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

干预措施: Execution of the Action (Other)

motor imagery, observation of the action, and execution of the action (GE1)

Experimental

in the sitting position, the participant will watch the recorded video to observe the action, for two minutes. Soon after, they will close their eyes, and receive the description of the action, through recorded audio of the same action, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 60 minutes of intervention.

干预措施: Motor Imagery (Other)

motor imagery, observation of the action, and execution of the action (GE1)

Experimental

in the sitting position, the participant will watch the recorded video to observe the action, for two minutes. Soon after, they will close their eyes, and receive the description of the action, through recorded audio of the same action, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 60 minutes of intervention.

干预措施: Action Observation (Other)

motor imagery, observation of the action, and execution of the action (GE1)

Experimental

in the sitting position, the participant will watch the recorded video to observe the action, for two minutes. Soon after, they will close their eyes, and receive the description of the action, through recorded audio of the same action, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 60 minutes of intervention.

干预措施: Execution of the Action (Other)

motor imagery and execution of the action (GE2)

Experimental

in the sitting position, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

干预措施: Motor Imagery (Other)

action observation and action execution (GE3)

Experimental

in the sitting position, the participant will watch the recorded video to perform the action observation, which will last two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

干预措施: Action Observation (Other)

action observation and action execution (GE3)

Experimental

in the sitting position, the participant will watch the recorded video to perform the action observation, which will last two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 40 minutes of intervention.

干预措施: Execution of the Action (Other)

motor imagery, execution of the action, and exoskeleton (GE4)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes. Then, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Motor Imagery (Other)

motor imagery, execution of the action, and exoskeleton (GE4)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes. Then, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Exoskeletons (Other)

motor imagery, execution of the action, and exoskeleton (GE4)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes. Then, the participant will close his eyes and will receive the description of the action, through recorded audio, to imagine it, for two minutes. In the sitting or standing position, depending on the action to be performed, the participant must execute the same action imagined previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Execution of the Action (Other)

observation of the action, execution of the action, and exoskeleton (GE5)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes.

Then, the participant will watch the recorded video to observe the action, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Action Observation (Other)

observation of the action, execution of the action, and exoskeleton (GE5)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes.

Then, the participant will watch the recorded video to observe the action, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Exoskeletons (Other)

observation of the action, execution of the action, and exoskeleton (GE5)

Experimental

in the sitting position, the participant will perform the exoskeleton protocol for 40 minutes.

Then, the participant will watch the recorded video to observe the action, for two minutes. Then, in the sitting or standing position, depending on the action to be performed, the participant must execute the same action observed previously, for two minutes. Each session will have five different actions that will be repeated twice, totaling 80 minutes of intervention.

干预措施: Execution of the Action (Other)

结局指标

主要结局

Parkinson's Disease-Cognitive Rating Scale

时间窗: Pre Test: one day before the intervention; Pos Test: one day after the intervention.

The Parkinson's Disease Cognitive Rating Scale (PD-CRS) arises from the need for a more comprehensive approach to the cognitive assessment of front-subcortical and cortical functions impaired throughout PD. In PD-CRS there are nine functions assessed, seven involving the "frontal-subcortical": sustained attention, working memory, the immediate and delayed evocation of verbal memory (word list), alternating verbal fluency, verbal fluency of actions, and spontaneous clock drawing; and two involving the "posterior cortical": naming twenty figures by visual confrontation, added to copying the clock drawing. The administration time is approximately 20 minutes, and training is available in the public domain. The total score of the PD-CRS is 134 points, with the ideal cutoff score being 81 points, and a score less than or equal to 64 points indicates PD with dementia.

次要结局

  • Unified Parkinson's Disease Rating Scale of the Movement Disorders Society(Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).)
  • Test TEMPA(Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).)
  • 9-Hole Peg Test(Pre Test: one day before the intervention; Pos Test: one day after the intervention.)
  • Canadian Occupational Performance Measure(Pre Test: one day before the intervention; Pos Test: one day after the intervention (last session).)

研究者

发起方
Federal University of Health Science of Porto Alegre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Cechetti

Clinical Professor, Ph.D Fernanda Cechetti

Federal University of Health Science of Porto Alegre

研究点 (1)

Loading locations...

相似试验