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临床试验/NCT06154356
NCT06154356招募中不适用

Effect of Action Observation and Motor Imagery Therapy on Balance, Functional Status and Quality of Life in Parkinson's Disease, Randomized Controlled Trial

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年12月14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
54
试验地点
1
主要终点
The difference in the scores of the Timed Up and Go Test 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 Parkinson's disease (PD). 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.

The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status and Quality of Life.

详细描述

Parkinson's disease (PD) is a neurodegenerative disease with a chronic and progressive course. Freezing phenomena, gait disorders, and balance problems are common in PD. Gait and balance disorders and motor freezing attacks that occur as a result of PD increase the risk of falling, leading to a decrease in functional independence and quality of life. The main goal of Parkinson's rehabilitation is to ensure the maximum functional status and independence in daily living activities and to increase their quality of life.

In recent years, motor imagery (MI) and action observation (AO) therapy strategies have been used in rehabilitation programs to increase motor learning in PD. 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.

The aim of this clinical trial is to test whether the application of AO and MI treatment in PD in addition to conventional rehabilitation programs has an additional effect on Balance, Functional Status 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)

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 with a diagnosis of Parkinson's Disease
  • Hoehn and Yahr Stage 1-3

排除标准

  • 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)

研究组 & 干预措施

Action observation and motor imagery therapy for rehabilitation

Experimental

Action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.

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

Sham action observation and motor imagery therapy for rehabilitation

Sham Comparator

Sham comparator for action observation and motor imagery therapy for rehabilitation in Parkinson's Disease in addition to conventional rehabilitation programs.

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

结局指标

主要结局

The difference in the scores of the Timed Up and Go Test 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 Timed Up and Go Test between pre- and post-rehabilitation assessments

The difference in the scores of the Berg Balance Scale 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 Berg Balance Scale between pre- and post-rehabilitation assessments. Berg Balance Scale consists of 14 items. Total score ranges from 0 to 56. Higher scores indicate better balance.

The difference in the scores of the Five Times Sit to Stand Test 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 Five Times Sit to Stand Test between pre- and post-rehabilitation assessments

The difference in the scores of the The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale pre- and post-rehabilitation assessments

时间窗: 6 weeks

Univariate statistical analyses will be performed to calculate differences in the scores of the The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale between pre- and post-rehabilitation assessments. The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) consists of four sections: Part 1: non-motor experiences of daily living, Part 2: motor experiences of daily living, Part 3: motor examination, Part 4: motor complications. It consists of a total of 50 questions. In this study, sections II (motor experiences of daily living) and III (motor examination) will be used. Each item is is scored between 0 and 4. Higher values indicate that the patient's condition is worse.

次要结局

  • The difference in the scores of the Parkinson's Disease Questionnaire between pre- and post-rehabilitation assessments(6 weeks)
  • The difference in the scores of the Freezing of Gait Questionnaire between pre- and post-rehabilitation assessments(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 (1)

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