Mild Cognitive ImpairmentNCT03522389
Effect of Action Observation Training on Gait Variables and Global Cognitive Functions
A study testing AOT with gait training, Gait training and Education in people with Mild Cognitive Impairment, run by Mahidol University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- AOT with gait training, Gait training and Education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteThailand
- Study dates
- 15 May 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
About this study
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
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- AOT with gait training, Gait training, Education
- Keywords
- Action Observation Training, Gait
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AOT with gait trainingProcedure or surgery
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.
Gait trainingProcedure or surgery
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AOT with gait training group | Experimental | Action observation training with gait training Receives: Procedure: AOT with gait training |
| Gait training group | Active comparator | Gait training Receives: Procedure: Gait training |
| Control group | Other | Education Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed During the Single Task
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)
Measured: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Gait Speed During the Dual Task
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).
Measured: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Secondary outcomes (3)
Stride Time Variability During Single Task
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).
Measured: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Stride Time Variability During Dual Task
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).
Measured: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start15 May 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rommanee Rojasavastera, Principal investigator, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522389
- Sponsor's protocol ID
- MU-CIRB 2018/001.0301
- Status last verified
- Jun 2025
- First submitted
- 17 Apr 2018
- Last updated
- 3 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03522389
- Acronym / sponsor ID
- MU-CIRB 2018/001.0301
- Conditions
- Mild Cognitive Impairment
- Keywords
- Action Observation Training, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Posted 3 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AOT with gait training group | Experimental | Procedure: AOT with gait trainingAction observation training with gait training |
| Gait training group | Active comparator | Procedure: Gait trainingGait training |
| Control group | Other | Other: EducationEducation |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AOT with gait trainingAOT 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. | Procedure or surgery | AOT with gait training group |
| Gait trainingTo 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. | Procedure or surgery | Gait training group |
| EducationThere 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. | Other | Control group |
Primary outcome
Gait Speed During the Single Task
Time frame: 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
Time frame: 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).
3 secondary outcomes
Stride Time Variability During Single Task
Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Stride Time Variability During Dual Task
Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMontero-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rommanee Rojasavastera principal investigator
Faculty of Physical Therapy, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AOT with gait training, Gait training and Education in people with Mild Cognitive Impairment, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed During the Single Task (time frame: Baseline (T1), After 4 weeks of training (T2), and 1-month follow-up (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03522389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.