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临床试验/NCT03251209
NCT03251209Unknown不适用

Influence of Mental Practice on Manual Dexterity Associated Before and After Physical Practice in Patients With Stroke Sequelae

Universidade Federal do Rio Grande do Norte2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年4月20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
30
试验地点
2
主要终点
Fugl-Meyer Scale

研究概览

简要总结

Among the limitations caused by cerebrovascular accident (CVA), the upper limb (MS) undergoes changes that limit the individual in his ability to maintain an active social life. Mental Practice (MP) consists of the internal reproduction of an event, which is repeated extensively in order to learn or improve an already known skill. The objective of the study is evaluate the effects of the physical practice associated with PM, on paretic MS. Subjects with unilateral stroke over 6 months, age> 18 years and who were able to hold objects will be selected. Subjects with painful conditions that affected exercise performance,> 3 spasticity by Ashworth, and cognitive deficit suggested by the Mini Mental State Examination will be excluded.

详细描述

There are 3 study protocols. The MP protocol 1 comprise 4 steps: 1) 5 minutes of global relaxation; 2) Video therapy, being 2 minutes / task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles); 3) MP: think about the tasks assisted in the video for 5 minutes / task. 4) Physical Practice: reproduce through the motor execution, the activities assisted in the video (5 minutes / task). The MP protocol 2 was the same, changing the order: first physical practice and after MP. For the protocol 3 without PM, step 3 was suppressed, remaining the remaining steps. There were 15 sessions, 2x / week, for 1 hour. The Fugl-Meyer (FM) Scales, Ashworth Modified Scale (EMA), Functional Independence Measurement (MIF), Action Research Arm Test (ARAt), Box and block task (BBT) and Theory of mind battery (ToM) will be applied before and after the sessions, and in 3 months follow-up.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of stroke, ischemic or hemorrhagic, for more than 6 months, age above 18 years, unilateral involvement and are able to hold objects

排除标准

  • Painful conditions that affect the ability to perform the proposed exercises, spasticity greater than 3 by the Ashworth Scale and cognitive deficits that will be evaluated by the Mini Mental State Examination (MMSE)

研究组 & 干预措施

Group 1

Experimental

Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.

干预措施: Physical practice (Other)

Group 1

Experimental

Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.

干预措施: Mental practice (Other)

Group 1

Experimental

Post-stroke participants receive the mental practice before the physical practice. The activities will be presented in a videotherapy way.

干预措施: Videotherapy (Other)

Group 2

Experimental

Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.

干预措施: Physical practice (Other)

Group 2

Experimental

Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.

干预措施: Mental practice (Other)

Group 2

Experimental

Post-stroke participants receive the mental practice after the physical practice. The activities will be presented in a videotherapy way.

干预措施: Videotherapy (Other)

Group 3

Active Comparator

Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.

干预措施: Physical practice (Other)

Group 3

Active Comparator

Post-stroke participants receive only physical practice. The activities will be presented in a videotherapy way.

干预措施: Videotherapy (Other)

结局指标

主要结局

Fugl-Meyer Scale

时间窗: Change from baseline sensory-motor impairmente at 8 weeks and 3 months (follow-up).

Sensory-motor impairment of upper limb

surface electromyography

时间窗: change from baseline muscle activity at 8 weeks and 3 months (follow-up)

Short radial extensor of the carpus and superficial flexor of the fingers

Functional independence measure (FIM)

时间窗: change from baseline functional independence at 8 weeks and 3 months (follow-up)

assess the dependence of others for activities of daily living

Action Research Arm Test (ARAT)

时间窗: change from baseline dexterity at 8 weeks and 3 months (follow-up)

functional test of upper limb

Box and Block test (BBT)

时间窗: change from baseline dexterity at 8 weeks and 3 months (follow-up)

manual dexterity

次要结局

  • Theory of Mind Task Battery (ToM)(change from mental function baseline at 8 weeks)
  • Modified ashworth scale (MAS)(change fom baseline muscle tone at 8 weeks and 3 months (follow-up))
  • Kinesthetic and Visual Imagery Questionnaire (KVIQ - 10)(change from baseline capacity of imagination at 8 weeks)
  • Mini-mental State Examination(baseline)
  • Movement Imagery Questionnaire-Revised second version (MIQ-RS)(change from baseline ability to imagine at 8 weeks)

研究者

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

Roberta de Oliveira Cacho

PhD

Universidade Federal do Rio Grande do Norte

研究点 (2)

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