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临床试验/NCT06166862
NCT06166862招募中不适用

Effect of Action Observation and Motor Imagery Therapy on Balance, Functional Status and Quality of Life in Stroke, Randomized Controlled Trial

Karamanoğlu Mehmetbey University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2023年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
56
试验地点
2
主要终点
The difference in the scores of the Brunnstrom stages between pre- and post-rehabilitation assessments

研究概览

简要总结

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in stroke. Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

This clinical trial aims to test whether the application of AO and MI treatment in stroke in addition to conventional rehabilitation programs has an additional effect on motor recovery, activities of daily living, and quality of life.

详细描述

Stroke is one of the most common neurological disorders that causes chronic disability in adulthood. Stroke-related neurological dysfunction causes impairment in motor and sensory skills and limitation in the ability to perform daily living activities, resulting in decreased independence of patients. This process causes significant impairment in the quality of life of stroke patients.

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in stroke. Visuomotor training strategies such as AO and MI therapy rely on the activity of the mirror neuron system to facilitate motor re-learning. Mirror neurons are activated during the performance of goal-directed actions, also when observing the same action and visualizing the action in the mind.

This clinical trial aims to test whether the application of AO and MI treatment in stroke in addition to conventional rehabilitation programs has an additional effect on motor recovery, activities of daily living, and quality of life.

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
Single (Outcomes Assessor)

盲法说明

Single

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had a stroke in the last year
  • Functional Ambulation Classification score 2-5

排除标准

  • Patients who have had repeated strokes
  • Patients with neglect
  • Patients with cognitive dysfunction (those who cannot follow simple verbal instructions)
  • Patients with severe hearing problems
  • Patients with severe vision problems
  • Patients with additional musculoskeletal system pathology that will affect physical performance (such as amputation, severe joint mobility limitation, peripheral nerve damage)
  • Patients with uncontrolled hypertension and diabetes mellitus
  • Patients with a history of symptomatic lung disease (such as asthma, chronic obstructive pulmonary disease, emphysema)
  • Patients with a history of symptomatic cardiac disease (such as coronary artery disease, arrhythmia, heart failure)
  • Patients with peripheral artery disease

研究组 & 干预措施

Sham action observation and motor imagery therapy for rehabilitation

Sham Comparator

Sham comparator for action observation and motor imagery therapy for rehabilitation in stroke patients in addition to conventional rehabilitation programs.

干预措施: Sham action observation and motor imagery therapy for rehabilitation (Other)

Action observation and motor imagery therapy for rehabilitation

Experimental

Action observation and motor imagery therapy for rehabilitation in stroke patients in addition to conventional rehabilitation programs.

干预措施: Action observation and motor imagery therapy for rehabilitation (Other)

结局指标

主要结局

The difference in the scores of the Brunnstrom stages between pre- and post-rehabilitation assessments

时间窗: 6 weeks

Univariate statistical analyses will be performed to calculate differences in the scores of the Brunnstron stages between pre- and post-rehabilitation assessments. Brunnstrom staging assesses the motor recovery process of the hemiplegic patient in 6 stages (Stages 1 to 6). Upper extremity, lower extremity, and hand are evaluated separately. Higher stages indicate better motor function.

The difference in the scores of the Fugl-Meyer Assessment between pre- and post-rehabilitation assessments

时间窗: 6 weeks

Univariate statistical analyses will be performed to calculate differences in the scores of the Fugl-Meyer Assessment between pre- and post-rehabilitation assessments. The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The motor domain is used in this study, which includes items assessing movement, coordination, and reflex action of the upper and lower extremities. Motor score ranges from 0 (hemiplegia) to 100 points (normal motor performance). Divided into 66 points for upper extremity and 34 points for the lower extremity.

次要结局

  • The difference in the scores of the Barthel Index between pre- and post-rehabilitation assessments(6 weeks)
  • The difference in the scores of the Stroke-Specific Quality of Life Scale between pre- and post-rehabilitation(6 weeks)

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yurdagül Bahran Muştu

M.D., Principal investigator

Karamanoğlu Mehmetbey University

研究点 (2)

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