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临床试验/NCT03522389
NCT03522389已完成不适用

The Effect of Action Observation Training on Gait Variables and Global Cognitive Functions in Older Adult With Mild Cognitive Impairment: A Randomized Controlled Trial

Mahidol University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年5月15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
入组人数
39
试验地点
2
主要终点
Gait Speed During the Single Task

研究概览

简要总结

This study will investigate the effect of Action Observation Teaining (AOT) on gait variables and global cognitive functions in older adults with mild cognitive impairment (MCI).

The specific objectives are 1) to compare gait variables and global cognitive functions among the AOT with gait training, gait training, and control groups at before training, after training, and follow up and 2) to compare gait variables and global cognitive functions among before training, after training, and follow up in each of the groups.

详细描述

Participants in this study will be older adults recruiting from the Physical Therapy Center of Mahidol University, Siriraj hospital, and community at Phuttamonthon area (n = 39).

They will be diagnosed as a MCI, using core clinical criteria of the National Institute on Aging and the Alzheimer's Association by a physiotherapist. Prior to participate in the study, participants will be informed the details of the study and sign the informed consent. All participants will be recorded the demographic data and will be assessed visual acuity, hearing, sensation and muscle strength of lower extremity, balance, gait variables, and global cognitive function.

Participants who pass the criteria will be randomly assigned to either the AOT with gait training group (n = 13), the gait training group (n = 13), and the control group (n = 13) by stratified randomization.

Gait variables will be collected by the Force Distribution Measurement platform during walking at comfortable speed (single task) and during counting backwards from 100 by sevens (dual tasks). Global cognitive function will be assessed by the Montral Cognitve Assessment (MoCA).

All varaibles will be assessed 3 times which will be at before training, after 4-week of training, and 4-week 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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Aged 60-80 years old.
  • Having subjective evidence of cognitive decline from patients, or from closely informants, or from a clinicians.
  • Having objective evidence of cognitive decline, defined by using a Montreal Cognitive Assessment (MoCA) 18-24 points.
  • Independent function in daily life
  • Independent walking without using gait aids.
  • Having fall risk, defined by the fall risk threshold (gait velocity < 1 m/s in walking while counting backwards from 100 by sevens).
  • Able to understand Thai language and follow study protocol.

排除标准

  • Having history of stroke or heart attack or Parkinsonism symptoms.
  • The presence of major depression disorder defined by a Patient Health Questionnaire-9 > 9 points.
  • Diagnosis as dementia by neurologists.
  • Any cardiac or respiratory disease that could cause gait limiting.
  • Musculoskeletal disorder that affected gait performance.
  • Balance disorder in assessment day, such as vertigo and dizziness.
  • Visual acuity with a glasses worse than 6/15 (metric system) in both their eyes.

研究组 & 干预措施

AOT with gait training group

Experimental

Action observation training with gait training

干预措施: AOT with gait training (Procedure)

Gait training group

Active Comparator

Gait training

干预措施: Gait training (Procedure)

Control group

Other

Education

干预措施: Education (Other)

结局指标

主要结局

Gait Speed During the Single Task

时间窗: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

Gait speed during the single-task condition was measured in meter per second while participants walked at a comfortable pace over a measurement platform without performing any secondary task. Higher gait speed values indicate better physical function and mobility, whereas lower values may reflect impaired motor performance or increased risk of functional decline. Unit of Measure: meters per second (m/s)

Gait Speed During the Dual Task

时间窗: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)

Gait speed during the dual-task condition was measured in meters per second (m/s), while participants walked at a comfortable pace over a measurement platform while simultaneously counting a number backward by 7. Higher gait speed values indicate better cognitive-motor performance, while lower values suggest impaired dual-task ability and potential functional or cognitive decline. Unit of Measure: meters per second (m/s).

次要结局

  • Stride Time Variability During Single Task(Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3))
  • Stride Time Variability During Dual Task(Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3))
  • Montreal Cognitive Assessment (MoCA)(Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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