Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AOT with gait training
Gait training
Education
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Action Observation Training, Gait
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
AOT with gait training group
Gait training group
Control group
Arm Description
Action observation training with gait training
Gait training
Education
Outcomes
Primary Outcome Measures
Changed score of stride time variability in single-task condition
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
Changed score of stride time variability in dual -task condition
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 gait velocity in single-task condition
It will be calculated from distance divided by time.
Changed score of gait velocity in dual -task condition
Gait velocity in walking while counting backwards from 100 by sevens, will be calculated from distance divided by time.
Changed score of MoCA
Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03522389
Brief Title
Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
Official Title
The Effect of Action Observation Training on Gait Variables and Global Cognitive Functions in Older Adult With Mild Cognitive Impairment: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2018 (Anticipated)
Primary Completion Date
January 31, 2019 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Action Observation Training, Gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AOT with gait training group
Arm Type
Experimental
Arm Description
Action observation training with gait training
Arm Title
Gait training group
Arm Type
Active Comparator
Arm Description
Gait training
Arm Title
Control group
Arm Type
Other
Arm Description
Education
Intervention Type
Procedure
Intervention Name(s)
AOT with gait training
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gait training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changed score of stride time variability in single-task condition
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changed score of stride time variability in dual -task condition
Description
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.
Time Frame
8 weeks
Title
Changed score of gait velocity in single-task condition
Description
It will be calculated from distance divided by time.
Time Frame
8 weeks
Title
Changed score of gait velocity in dual -task condition
Description
Gait velocity in walking while counting backwards from 100 by sevens, will be calculated from distance divided by time.
Time Frame
8 weeks
Title
Changed score of MoCA
Description
Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rommanee Rojasavastera
Phone
66-83-783-0777
Email
rommanee49062@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sunee Bovonsunthonchai
Phone
66-86-972-7888
Email
sunee.bov@mahidol.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rommanee Rojasavastera
Organizational Affiliation
Faculty of Physical Therapy, Mahidol University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
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Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
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