Clinical trial NCT03522389: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Action Observation Training
Gait
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changed score of stride time variability in single-task condition
timeFrame: 8 weeks
Secondary outcomes:
measure: Changed score of stride time variability in dual -task condition
timeFrame: 8 weeks
measure: Changed score of gait velocity in single-task condition
timeFrame: 8 weeks
measure: Changed score of gait velocity in dual -task condition
timeFrame: 8 weeks
measure: Changed score of MoCA
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Physical Therapy, Mahidol University
name: Rommanee Rojasavastera
role: PRINCIPAL_INVESTIGATOR
References:
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.