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

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Procedure: AOT with gait training; Procedure: Gait training; Other: Education

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 Type: Interventional
• Enrollment (Anticipated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rommanee Rojasavastera; Phone Number: 66-83-783-0777; Email: rommanee49062@hotmail.com
• Study Contact Backup: Name: Sunee Bovonsunthonchai; Phone Number: 66-86-972-7888; Email: sunee.bov@mahidol.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks
Changed score of gait velocity in single-task condition	It will be calculated from distance divided by time.	8 weeks
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.	8 weeks
Changed score of MoCA	Global cognitive functions will be collected using a Montreal Cognitive Assessment (MoCA)	8 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Rommanee Rojasavastera, Faculty of Physical Therapy, Mahidol University

Publications and helpful links

General 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 record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2018
• Primary Completion (Anticipated): January 31, 2019
• Study Completion (Anticipated): January 31, 2019

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Gait; Action Observation Training
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: MU-CIRB 2018/001.0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No