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

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ClinicalTrials.gov Identifier: NCT03522389
Recruitment Status : Unknown
Verified May 2018 by Mahidol University.
Recruitment status was:  Not yet recruiting
First Posted : May 11, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Procedure: AOT with gait training Procedure: Gait training Other: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 15, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Arm Intervention/treatment
Experimental: AOT with gait training group
Action observation training with gait training
Procedure: AOT with gait training

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.


Active Comparator: Gait training group
Gait training
Procedure: Gait training

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.


Control group
Education
Other: Education
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 Measures :
  1. Changed score of stride time variability in single-task condition [ Time Frame: 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 :
  1. Changed score of stride time variability in dual -task condition [ Time Frame: 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.

  2. Changed score of gait velocity in single-task condition [ Time Frame: 8 weeks ]
    It will be calculated from distance divided by time.

  3. Changed score of gait velocity in dual -task condition [ Time Frame: 8 weeks ]
    Gait velocity in walking while counting backwards from 100 by sevens, will be calculated from distance divided by time.

  4. Changed score of MoCA [ Time Frame: 8 weeks ]
    Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522389


Contacts
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Contact: Rommanee Rojasavastera 66-83-783-0777 rommanee49062@hotmail.com
Contact: Sunee Bovonsunthonchai 66-86-972-7888 sunee.bov@mahidol.edu

Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Rommanee Rojasavastera Faculty of Physical Therapy, Mahidol University
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.

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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT03522389    
Other Study ID Numbers: MU-CIRB 2018/001.0301
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Action Observation Training
Gait
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders