NCT03522389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6 years until next milestone

Results Posted

Study results publicly available

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

1.1 years

First QC Date

April 17, 2018

Results QC Date

May 26, 2025

Last Update Submit

June 14, 2025

Conditions

Keywords

Action Observation TrainingGait

Outcome Measures

Primary Outcomes (2)

  • 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)

    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).

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

Secondary Outcomes (3)

  • 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)

Study Arms (3)

AOT with gait training group

EXPERIMENTAL

Action observation training with gait training

Procedure: AOT with gait training

Gait training group

ACTIVE COMPARATOR

Gait training

Procedure: Gait training

Control group

OTHER

Education

Other: Education

Interventions

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.

AOT with gait training group
Gait trainingPROCEDURE

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.

Gait training group

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.

Control group

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Sunee Bovonsunthonchai
Organization
Mahidol University

Study Officials

  • Rommanee Rojasavastera

    Faculty of Physical Therapy, Mahidol University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 11, 2018

Study Start

May 15, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 3, 2025

Results First Posted

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations