Effect of Action Observation Training on Gait Variables and Global Cognitive Functions

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Procedure: AOT with gait training; Other: Education; Procedure: Gait training

• Registration Number: NCT03522389
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-30
• Status Verified: 2018-05
• Study First Posted: 2018-05-11
• Last Update Submitted: 2018-05-11
• Study Start: 2018-05-15
• Last Update Posted: 2018-05-16
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AOT with gait training group	AOT with gait training	Action observation training with gait training
Control group	Education	Education
Gait training group	Gait training	Gait training

Primary Outcome Measures

Name	Time	Method
Changed score of stride time variability in single-task condition	8 weeks	Stride time variability in self-selected speed of walking. It is duration between successive points of heel contact of the same foot. The coeffcient of variation (CV), which measures the variability of stride time, will be calculated as a ratio of the standard deviation of the mean stride time to the mean stride time multiplied by 100.

Secondary Outcome Measures

Name	Time	Method
Changed score of stride time variability in dual -task condition	8 weeks	Stride time variability in walking while counting backwards from 100 by sevens. It is duration between successive points of heel contact of the same foot. The coeffcient of variation (CV), which measures the variability of stride time, will be calculated as a ratio of the standard deviation of the mean stride time to the mean stride time multiplied by 100.
Changed score of MoCA	8 weeks	Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)
Changed score of gait velocity in single-task condition	8 weeks	It will be calculated from distance divided by time.
Changed score of gait velocity in dual -task condition	8 weeks	Gait velocity in walking while counting backwards from 100 by sevens, will be calculated from distance divided by time.