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临床试验/NCT05934344
NCT05934344招募中不适用

Assessment of Motor and Social Changes Following Intervention With Observation/Action Training (AOT) Among Patients With Mild Cognitive Impairment

Universidad Europea de Madrid2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
45
试验地点
2
主要终点
Changes Functionality

研究概览

简要总结

Mild cognitive impairment (MCI) is a transitional state between normal aging and early dementia, characterized by memory deficits without functional impairment. Cognitive decline prevalence is increasing in older adults, impacting independence and quality of life. Motor dysfunctions, often overlooked in MCI, contribute to these limitations. Action Observation Therapy (AOT), a rehabilitation approach involving observing and imitating motor gestures, promotes brain plasticity through the mirror neuron system. While AOT has shown effectiveness in various populations, its application in MCI is understudied. This study aims to investigate the effects of AOT on cognition, upper and lower limb function, daily activities, gait, and balance in MCI patients. It also compares outcomes when patients observe therapists or MCI individuals with similar characteristics. Primary objectives include comparing AOT efficacy between these groups and a control group. Secondary objectives focus on upper limb functionality, daily activities, balance, cognition, and gait.

详细描述

Introduction The term MCI (Mild Cognitive Impairment) refers to the transitional state between normal cognitive changes associated with aging and very early dementia. It is a disorder characterized by impairments in both short-term and long-term memory, but without functional deficits. MCI is considered a precursor to dementia.

According to the World Health Organization (WHO), it was estimated that in 2014 there were 5.0 million adults with cognitive impairment (CI) in the population aged 65 years and older, and it is projected that by 2060, this number will increase to nearly 14 million. A study by Gómez on sentinel health networks in Spain describes a prevalence of MCI among individuals aged 65 years and older ranging from 14.5% to 17.6% , which increases with age. Another study reports a prevalence of 11.6% in individuals aged 65 to 69 years, which rises to an average of 22.9% among those aged 85 years and older. Furthermore, a meta-analysis of 9 Spanish studies on different types of dementia showed a prevalence ranging from 3.2% to 12.3% in individuals aged 70 years and older, with higher prevalence in women and increasing with age.

Activities of daily living (ADL) rely on a combination of motor, cognitive, and socioemotional skills . Therefore, CI can directly impact independence in ADL, leading to immobility and social isolation . These factors increase the likelihood of individuals with CI requiring admission to specialized care centers.

Gait and balance impairments are common in individuals with dementia, including slower gait speeds, decreased stride length, altered swing time, among others. However, these motor alterations are often overlooked when addressing CI . Balance impairment combined with gait deficits significantly increases the risk of falls, with approximately 60% of individuals with CI experiencing falls annually, twice as frequently as cognitively intact counterparts . Individuals with CI are also more prone to falls resulting in injuries, with up to a three-fold increase in the incidence of hip fractures compared to those without CI. Recognizing and addressing this connection between cognitive and motor deficits is crucial .

A systematic review from 2018 concluded that combining physical training with cognitive training in a functional context can help mitigate some aspects of CI. Therefore, the evidence supports that cognitive intervention should be concurrent with physical exercises rather than separate .

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
None

入排标准

年龄范围
65 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Residents or day care center users without visual or auditory impairments that cannot be corrected with the use of devices (such as glasses or hearing aids) and without any conditions affecting their upper limbs.
  • Residents with mild cognitive impairment (MoCA score <26) (23).
  • Patients capable of walking at least 10 meters without severe pain in the lower limbs (according to the Visual Analog Scale).
  • Patiens capable to perform the tests without the use of external aids or with the use of assistive devices such as a cane, and without medical contraindications for exercise.

排除标准

  • The patients without cognitive impairment will be selected based on a MoCA score ranging from 26 to 30,
  • Patients without any other neurological or musculoskeletal pathology.
  • Patients with no upper limb disorders.
  • Patients inability to complete the intervention full-time,
  • Patients with presence of aggressive behavior or disturbances,
  • Patients with inability to communicate verbally.

结局指标

主要结局

Changes Functionality

时间窗: Before and after the intervention: 5 weeks

Fugl-meyer scale

Changes Upper limb dexterity

时间窗: Before and after the intervention: 5 weeks

Box and block test

Changes Activities of daily living

时间窗: Before and after the intervention: 5 weeks

Barthel index

Changes gait

时间窗: Before and after the intervention: 5 weeks

10 Meters Walking Tes

Changes cognitive impairment

时间窗: Before and after the intervention: 5 weeks

Montreal Cognitive Assessment (MoCA)

Changes balance

时间窗: Before and after the intervention: 5 weeks

Berg Balance Scale

次要结局

未报告次要终点

研究者

发起方
Universidad Europea de Madrid
申办方类型
Other
责任方
Principal Investigator
主要研究者

Estrada Barranco

Clinical Professor

Universidad Europea de Madrid

研究点 (2)

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