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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
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Action Observation Training, Gait

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 17, 2018
    Last Updated
    May 11, 2018
    Sponsor
    Mahidol University
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    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.
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    Effect of Action Observation Training on Gait Variables and Global Cognitive Functions

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