- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03522389
Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
The Effect of Action Observation Training on Gait Variables and Global Cognitive Functions in Older Adult With Mild Cognitive Impairment: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nakhon Pathom
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Salaya, Nakhon Pathom, Thailand, 73170
- Faculty of Physical Therapy, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: AOT with gait training group
Action observation training with gait training
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AOT with gait training composes of program of watching video in different views of normal walk for 5 min. After that, participants will receive gait training program. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome. |
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Active Comparator: Gait training group
Gait training
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To control a total time of training, the gait training group will watch video of Vincent van Gogh's painting for 5 min. After that, participants will training the gait as protocol of experimental group. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome. |
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Other: Control group
Education
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There will be no intervention exercise program provide for the control group.
They will receive education about dementia such as definition, etiology, sign and symptom, and caring.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Gait Speed During the Single Task
Time Frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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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) |
Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Gait Speed During the Dual Task
Time Frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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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). |
Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stride Time Variability During Single Task
Time Frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Stride time variability during single task was measured while participants walked at a comfortable pace over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov). |
Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Stride Time Variability During Dual Task
Time Frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Stride time variability during dual-task walking was measured while participants walked at a comfortable pace, together with counting a number backward by 7 over a measurement platform. Stride time refers to the duration between successive heel contacts of the same foot. The variability of stride time was quantified using the coefficient of variation (CV), calculated as: (standard deviation of stride time / mean stride time) × 100. Higher CV values indicate greater variability in stride timing, which reflects reduced gait stability or impaired motor-cognitive coordination. Lower CV values are considered better outcomes, indicating more stable and consistent gait. Unit of Measure: percentage of coefficient of variation (% Cov). |
Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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The Montreal Cognitive Assessment (MoCA) is a global cognitive screening tool designed to assess multiple cognitive domains, including attention, memory, language, visuospatial skills, executive function, and orientation. The test consists of 30 points in total and ranges from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: scores. |
Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rommanee Rojasavastera, Faculty of Physical Therapy, Mahidol University
Publications and helpful links
General Publications
- Montero-Odasso M, Muir SW, Speechley M. Dual-task complexity affects gait in people with mild cognitive impairment: The interplay between gait variability, dual tasking, and risk of falls. Arch Phys Med Rehabil. 2012;93(2):293-9. Park H, Kim J, Lee M, Oh D. Clinical feasibility of action observation training for walking function of patients with post-stroke hemiparesis: a randomized controlled trial. Clin Rehabil. 2014;28(8):794-803. Scherder E, Eggermont L, Visscher C, Scheltens P, Swaab D. Understanding higher level gait disturbances in mild dementia in order to improve rehabilitation: 'Last in-first out'. Neurosci Biobehav Rev. 2011;35(3):699-714. Beauchet O, Launay CP, Annweiler C, Allali G. Hippocampal volume, early cognitive decline and gait variability: Which association? Exp Gerontol. 2015;61:98-104.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-CIRB 2018/001.0301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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