Cognitive-motor Training in Community-dwelling Older People With Mild Cognitive Impairment
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Sponsor: Mahidol University

1 
The Effect of SMART±STEP Cognitive-Motor 
Training in Community-Dwelling Older People 
with Mild Cognitive Impairment: A Single-Blind 
Randomized Controlled Trial 
Version Number: 1 
Date of Protocol: 18 November 2025 

 
2 
SYNOPSIS 
Protocol title:  
The Effect of SMART±STEP Cognitive-Motor Training in Community-
Dwelling Older People with Mild Cognitive Impairment: A Single-Blind 
Randomized Controlled Trial 
Protocol version: 
1.0 
LIST OF INVESTIGATORS 
Principal Investigators: 
Dr Thanwarat Chantanachai 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University  
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  
Telephone no:  
 
+66 815235692 
E-mail: 
 
 
thanwarat.cha@mahidol.edu 
Co Investigator:  
 
Dr Jenjira Thanakamchokchai 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University 
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  
Telephone no:  
 
+66 24415450#21102 
E-mail: 
 
 
jenjira.tha@mahidol.ac.th 
Co Investigator: 
 
Dr Daina Sturnieks 
Organisation: 
School of Biomedical Sciences, Faculty of Medicine and Health, 
University of New South Wales and Neuroscience Research 
Australia, Sydney, Australia 
Address: 
PO Box 1165, Randwick, Sydney, NSW 2031 Australia 
E-mail:  
 
 
d.sturnieks@neura.edu.au 
Co Investigator: 
 
Dr Kittichai Tharawadeepimuk 
Organisation:  
 
College of Sports Science and Technology, Mahidol University 
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  

 
3 
Thailand 
 
E-mail: 
 
 
 kittichai.tha@mahidol.edu 
Co Investigator: 
 
Mr. Poomwut Hiranphan 
Organisation:  
 
College of Sports Science and Technology, Mahidol University 
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand 
Telephone no:  
 
+66810376595 
E-mail: 
 
 
poomwut.hir@mahidol.ac.th 
Associate Investigator 
Ms Rommanee Rojasavastera 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University  
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  
Telephone no:  
 
+66837830777 
E-mail: 
 
 
rommanee.roj@mahidol.ac.th 
Associate Investigator 
Ms Irin Apiworajirawit 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University  
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  
E-mail: 
 
 
henghee.t@gmail.com 
Associate Investigator 
Ms Thatchaya Prathum 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University  
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  
E-mail: 
 
 
thatchaya.prt@gmail.com 
Associate Investigator 
Mr Songyos Piluek 
Organisation:  
 
Faculty of Physical Therapy, Mahidol University  
Address:  
 
 
999 Phuttamonthon 4 Road, Salaya, Nakhon Pathom 73170  
Thailand  

 
4 
Telephone no:  
 
+66 24415450 #20227 
E-mail: 
 
 
Songyos.pil@mahidol.ac.th 
 
 
RESEARCH SITES 
Faculty of Physical Therapy, Mahidol University 
FUNDING BACKGROUND 
 
Strategic Research Fund (Starter), Mahidol University 
Fundamental Fund by National Science Research and Innovation Fund (NSRF) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
5 
SUMMARY 
Study title: The Effect of SMART±STEP Cognitive-Motor Training in Community-Dwelling 
Older People with Mild Cognitive Impairment: A Single-Blind Randomized Controlled Trial 
Protocol version: 1 
Research Objectives 
Primary aim 
1. Assess the feasibility of Smart±step cognitive-motor training for older people with MCI 
2. Evaluate the program's impact on falls risk factors 
3. Examine neurophysiological outcomes 
Secondary aims 
1. Compare fall risk, program enjoyment, adherence, and adverse events at 3 months 
2. Assess 3-month effects on cognitive, physical, and psychological performance 
3. Evaluate 6-month impacts on fall risk factors and neurophysiological outcomes 
Study design: Single blind randomised control trial (RCT) 
Planned sample size: 70 participants, with 35 participants per group each phase. 
Selection criteria: The study will include Thai-speaking community-dwelling adults aged 60+ 
with mild cognitive impairment (MCI), who can walk 10m independently. Participants will be 
excluded if they have dementia, recent stroke, neurodegenerative disorders, residential care 
residence, uncorrectable sensory impairments, illiteracy, or medical conditions that could 
compromise study safety, including severe musculoskeletal pain, recent surgeries, unstable 
cardiovascular or metabolic conditions, and uncontrolled mental health disorders. 
Study procedure: All participants will undergo a comprehensive test battery including physical, 
cognitive, neurophysiological functional, and QOL assessments at baseline, at three months, at six 
months and at 12 months. The baseline and follow-up assessments will be completed at Faculty of 
Physical Therapy, Mahidol University Concealed randomisation will be performed by a person 
independent of the study after baseline assessment. The intervention group will endeavour to 
undertake conitive-motor training at home. The intervention involves three training sessions per 
week for 30 minutes per session. There are 2 phase of the intervention (phase 1: 3 months 
intervention and phase 2: 6 months intervention with differnce group of the participants). The 
control group will receive usual care and healthy living information. 
Sample size calculation: The sample size calculation was based on the Stroop Stepping Test, 
using an effect size of 0.15 and accounting for covariates like age, gender, education, and 
intervention. With 80% statistical power and a 5% Type I error rate, the study requires 55 
participants to detect a 15% change in cognitive and motor skills. Anticipating a 20% dropout rate, 
the total sample size was increased to 70 participants, with 35 participants per group.  
Analysis plan: An intention-to-treat analysis will be used for all analyses. General linear models 
will be used to assess the effect of group allocation on the continuously scored outcome measures. 
Modified Poisson regression models will be used to compare groups on dichotomous outcome 
measures. Predictors of adoption and adherence will be analysed using multivariate modelling 
techniques such as general linear models, multiple linear and logistic regression. Negative 
binomial regression will be used to compare the number of falls in the intervention and control 
group. 
Study duration: 12 months 
 

 
6 
The Effect of SMART±STEP Cognitive-Motor Training in Community-
Dwelling Older People with Mild Cognitive Impairment: A Single-Blind 
Randomized Controlled Trial 
 
OVERVIEW 
As the global population ages, mild cognitive impairment (MCI) presents a significant 
challenge, with prevalence ranging from 5% to 40% among older adults. Individuals with MCI 
face a substantially higher fall risk—five times greater than their cognitively intact peers—due to 
cognitive and physical impairments. Current research suggests that combined cognitive-motor 
interventions offer the most promising approach to fall prevention. The Smart±step exergaming 
program represents an innovative solution, integrating interactive computer gaming with targeted 
cognitive and physical challenges. This study aims to evaluate the Smart±step program's feasibility 
and effectiveness in reducing fall risks among community-dwelling older people with MCI, 
potentially offering a groundbreaking strategy for enhancing senior health and independence. 
 
BACKGROUND 
As the world population ages, the number of older individuals with physical frailty and 
cognitive impairments will increase.(1-2) The prevalence of mild cognitive impairment (MCI) in 
older adults ranges from 5 and 40 %,(3-4) varying due to inconsistent diagnostic criteria and 
sampling differences.(5-9) MCI is an intermediate state between normal cognitive ageing and 
dementia, significantly raises the risk of developing Alzheimer’s disease (10% to 47% per year) 
compared to those without MCI (1% to 2% per year).(9-12) Previous, but limited, literature has 
demonstrated that older people with MCI are at an increased risk of falls.(13-14) Reduced cognitive 
function has been associated with gait disturbances and balance deficits in older people with MCI 
(15-19), which may contribute to this increased fall risk.(17-18) Research has shown the odds of falling 
in cognitively impaired older people is 5 times greater than their cognitively intact peers, with the 
literature reporting fall prevalence of more than 60% in this population.(20-24) Older people with 
MCI, by definition, have preserved ability in activities of daily living (ADLs), this suggests that 
falls could be at least in part related with cognitive dysfunction. When compared to cognitively 
intact older people, physical impairments have also been demonstrated in older people with MCI, 

 
7 
but potentially these are below the threshold required to affect ADL performance or are mitigated 
by compensation strategies.(25-27) However, these physical impairments are still important in 
relation to fall risk.(20,24,28-29) Therefore, specifically targeted fall prevention interventions should 
address both cognitive and physical issues in this population. 
Cognitive training including computer-based training and training by therapists has been 
demonstrated to improve cognitive outcomes such as executive functioning, memory performance 
and attention and global cognitive function in older people with MCI.(30-33) Some of these cognitive 
functions (e.g. executive function and attention) have also been associated with falls in this 
population.(15,34-35) Physical exercise, specifically exercise that involves moderate to high 
challenge balance training, prevents falls in community-dwelling cognitively healthy older 
people.(36) In older people with MCI, a recent systematic review reported physical exercise can 
improve fall-related risk factors like walking speed and global cognitive function, while cognitive 
training alone did not improve cognitive fall-related outcomes in this population.(37) Combined 
interventions, involving both physical (motor) and cognitive training, have shown promise in 
relation to fall prevention in older people with MCI.(38-39) These studies have demonstrated that 
cognitive-motor interventions can improve balance, dual-task ability and cognitive outcomes.(37,39-
40) However, there is limited evidence that this approach can reduce fall risk factors in community-
dwelling older people with MCI.(37-39) Rigorous and robust evaluation of the fall prevention 
efficacy of cognitive-motor interventions in people with MCI is needed. 
The Smart±step exergaming program, is an interactive computer gaming system that 
targets both cognitive and motor training.(41) Smart±step  involves targeted stepping tasks 
combined with a variety of cognitive tasks using a step mat to engage with computerized video 
games. A recent large randomised controlled trial with three arms (cognitive-motor, seated 
cognitive, control) assessing Smart±step’s fall prevention efficacy showed that Smart±step’s 
cognitive-motor program significantly reduces the rate of falls compared to the control group in 
cognitively healthy populations.(42) However, such cognitive-motor exercise programs like 
Smart±step have not been tested in older people with MCI. Improving physical and cognitive 
function using novel combined approaches may offer additional value for preventing falls and 
improving function in this population.  
STUDY OBJECTIVES 
Hypothesis  

 
8 
Cognitive-motor training will maintain or improve cognitive performance, physical and 
functional performance, neurophysiological outcomes, and qality of life in community-dwelling 
older people with mild cognitive impairment, and prevent falls 
 
Primary aims: 
1. To evaluate the feasibility of Smart±step cognitive-motor training program in community-
dwelling older people with MCI 
2. To evaluate the effect of Smart±step cognitive-motor training on falls risk factors in 
community-dwelling older people with MCI 
3. To evaluate the effect of Smart±step cognitive-motor training on neurophysiological 
outcomes in community-dwelling older people with MCI 
Secondary aims: 
1. To compare the fall risk score, the enjoyment score of the program, the percentage of 
adherence and the percentage of adverse events before and at 3 months of Smart±step 
cognitive-motor training in community-dwelling older people with MCI. 
2. To evaluate the effect of 3 months of Smart±step cognitive-motor training on cognitive, 
physical and psychological performance (falls risk factors) in community-dwelling older 
people with MCI. 
3. To evaluate the effect of 6 months of Smart±step cognitive-motor training on falls risk 
factors and neurophysiological outcomes in community-dwelling older people with MCI. 
RESEARCH PLAN, METHODS AND TECHNIQUES  
Study Design 
A 12 month single-blind (assessor) randomised controlled trial (RCT) examining the 
effectiveness of Smart±step cognitive-motor training carried out at home for six months compared 
with no training will be undertaken in 70 community-dwelling older people with mild cognitive 
impairment. The intervention will exercise using Smart±step system at least 120 minutes per week 
for 12 weeks (phase 1) and 24 weeks (phase 2). The Smart±step will target both physical and 
cognitive training e.g. executive function, processing speed and attention. The control group will 
receive usual care and healthy living information. All participants will undergo a comprehensive 

 
9 
test battery including physical, cognitive, functional, psychological, neurophysiological, quality of 
life assessments at baseline, at three months, at six months (at completion of Smart±step cognitive-
motor training for intervention group) and at 12 months (i.e. six months after completion of 
Smart±step cognitive-motor training. The baseline and follow-up assessments will be completed 
in the participants’ home (or at the Faculty of Physical therapy, Mahidol university if the 
participant prefers). Trial reporting will be guided by the CONSORT guidelines. 
Figure 1. Study flow diagram 
 
Participant selection 
Seventy volunteers with MCI based on the core criteria outlined by the diagnostic 
scheme of MCI by Petersen(6) and the National Institute on Aging-Alzheimer's Association (43) 
and as follows: 
1) Subjective cognitive complaints (SCCs) will be assessed by using the four most 
frequently endorsed questions from participant’s subjective complaints questions by the Slavin et 
al. study.(44) There are three memory questions (“Have you noticed difficulties with your 
memory?”, “Compared to 5 years ago, do you now find that you lose track of what you are doing?”, 
and “In general how would you describe your memory as compared to 10 years ago”)  and one 

 
10 
nonmemory question (“Compared to 5 years ago, do you have more difficulty finding the right 
words?”). Each question will give a score of 1 (the complaint is endorsed) or 0 (the complaint is 
not endorsed), which will ask participants to rate the score by themselves. The score ≥ 3 will be 
considered to have subjective cognitive complaints. 
2) Objective cognitive impairment will be assessed by using the Montreal Cognitive 
Assessment Thai version (MoCA). The MoCA consists of 16 items and 11 categories covering 
multiple cognitive domains (e.g. visuospatial, executive functions, naming, memory, attention, 
language, abstraction, and orientation). The MoCA has been shown to be a sensitive tool for 
neurocognitive disorder detection. A cut-off score of <26 out of a possible 30 has been reported to 
discriminate normal cognitive function and MCI with high sensitivity (90%) and specificity (87%) 
for detecting MCI. A MoCA score under 21 points (after adding 1 point for people with ≤12 years 
of education) is sensitive (88%) and specific (95%) in discriminating mild Alzheimer’s disease 
(AD) from MCI.  Therefore, this study will use the MoCA to determine objective cognitive 
impairment; a score of 20-25/30 for participants with ≤12 years of education and a score of 21-
25/30 for participants with more than 12 years of education will be considered inclusion criteria.(45-
48) 
3) Normal or minimally impaired in functional abilities will be assessed by using the Bayer 
Activities of Daily Living Scale (B-ADL). The B-ADL will be administered by trained study staff. 
The B-ADL consists of 25 items that is to be answered by the caregiver.  Each B-ADL item is 
rated from 1 to 10, where 1 indicates ‘never’ and 10 indicates ‘always’ have difficulty. The total 
score the B-ADL range between values 1.00 and 10.00. The participates who obtain the score of 
<3 on the B-ADL will be considered as no functional impairment.(49-50) 
4) Participants will not have dementia as determined by the MoCA.  Participants scoring < 
20 with ≤12 years of education and those scoring <21 with more than 12 years of education will 
excluded as this cut-off has a high sensitivity and specificity for dementia.(45-48) 
 
Inclusion criteria 
• MCI defined using the above criteria. 
• Aged 60 years or more. 
• Living in the community or retirement village. 
• Thai-speaking language. 

 
11 
• Able to walk 10m independently (without a walking aid). 
 
Exclusion criteria 
• Diagnosis of dementia or Alzheimer’s disease at baseline by a specialist clinician (e.g. 
Geriatrician) or using the MoCA cut-point <20-21 (depending on education level). 
• Having had a stroke in the last 2 years. 
• Having a progressive neurodegenerative disorder e.g. Parkinson’s disease, Multiple 
sclerosis, amyotrophic lateral sclerosis (ALS). 
• Living in a residential aged care facility. 
• Having visual/hearing impairment that cannot be corrected with eyeglasses or hearing aids. 
• Unable to read or write. 
• A medical condition that would interfere with the safety and conduct of the training and 
testing protocol or interpretation of the results, such as: 
• Musculoskeletal conditions e.g. severe pain of lower extremities (pain score > 
4/10), recent TKR/THR (less than or equal to 12 months after operation) and 
recent fracture (12-months). 
• Cardiopulmonary conditions e.g. unstable angina, uncontrolled hypertension. 
• Metabolic conditions e.g. severe or poorly controlled diabetes. 
• Mental health conditions e.g. severe or poorly controlled depression or 
psychiatric condition. 
Recruitment 
Participants will be recruited from the Sawang Kanives Retirement Village in Bang Pu, as 
well as from Baan Ua-Athorn Buddhamonthon Sai 5 in Sam Phran, Maha Sawat Tambon, Salaya 
Tambon, and Khong Yong Tambon, all located in Phutthamonthon, Nakhon Pathom. Additionally, 
participants may include individuals who are users of the geriatric clinic at Luangphopern Hospital 
and Golden Jubilee Medical Center. Both Thanwarat (Principal Investigator) and Jenjira (Co-
Investigator) have extensive clinical volunteer experience within these communities. Their strong 
track record in successfully recruiting participants for clinical trials will significantly contribute to 
maximizing recruitment for this study. 
 
Baseline, reassessment and follow-up assessment 

 
12 
Baseline, reassessment and follow-up assessments will be conducted in the participants’ 
homes by trained assessors. The baseline assessment will involve a structured interview with the 
participant to obtain demographic, health, physical activity and lifestyle information. 
Reassessment will be undertaken at three months, six months and an additional follow-up 
assessment at 12 months. Reassessment and follow-up assessors will be blinded to group 
allocation. Table 1 outlines the assessments to be completed. 
Table 1 List of assessments to be completed at Baseline (B), 3-month reassessment (3-mo), 6-
month postintervention (6-mo), and follow-up (12-mo) indicating primary (P) and secondary (S) 
outcomes (O) 
Assessment/Outcome variable 
B 
3-
mo 
6-
mo 
12-
mo 
O 
Socio-demographics  
Age, gender, marital status, education, type of residence, number 
of co-inhabitants, previous technology use  
/ 
X 
X 
X 
- 
General health and function  
Medical conditions, medication use, mobility, ADLs, history of 
falls 
/ 
X 
X 
X 
- 
Physical Assessment  
Stroop stepping test (SST) 
/ 
/ 
/ 
/ 
P 
Physiological profile assessment (PPA) 
/ 
/ 
/ 
/ 
P 
Timed Up and Go Test (TUG) (single and dual task) 
/ 
/ 
/ 
/ 
S 
Short Physical Performance Battery (SPPB) 
/ 
/ 
/ 
/ 
S 
30s-Chair-Stand Test (CST) 
/ 
/ 
/ 
/ 
S 
Cognitive assessment 
Trail-Making Test (TMT) Part A and B 
/ 
/ 
/ 
/ 
P 
The Controlled Oral Word Association test (COWAT) 
/ 
/ 
/ 
/ 
S 
The modified switching verbal fluency test (mSVF) 
/ 
/ 
/ 
/ 
S 
The digit symbol substitution 
/ 
/ 
/ 
/ 
S 
The Digit Span test (DST)  
/ 
/ 
/ 
/ 
S 
Psychological function 

 
13 
Short Falls Efficacy Scale international: Short FES-I  
/ 
/ 
/ 
/ 
S 
Thai Geriatric Depression Scale: TGDS 
/ 
/ 
/ 
/ 
S 
Thai Geriatric Anxiety Scale: Thai GAS-10 
/ 
/ 
/ 
/ 
S 
Neurophysiological assessment  
EEG 
/ 
/ 
/ 
/ 
S 
ERP 
/ 
/ 
/ 
/ 
S 
Physical activity  
Physical Activity Scale for Elderly Thai version (PASE-TH) 
/ 
/ 
/ 
/ 
S 
Quality of life  
WHOQOL–BREF–THAI 
/ 
/ 
/ 
/ 
S 
Prospective falling record 
Falls rate (monthly diaries and telephone calls) 
X 
/ 
/ 
/ 
S 
Usability  
System Usability Scale  
X 
/ 
/ 
X 
S 
Enjoyment 
Physical Activity Enjoyment Scale (PACES) Thai version 
X 
/ 
/ 
X 
S 
Adherence  
Sessions and time recorded by training system and logbook 
record 
X 
/ 
/ 
X 
S 
 
Primary outcome measures 
Stroop stepping test (SST) will be used to measure the ability to perform accurate stepping 
with response inhibition using the Choice Stepping Reaction Time Test. (51) This equipment 
consists of a custom-made dance pad (150×90cm) which is connected to a computer and display 
screen (1280 × 768 pixels; 60 Hz; 58 cm). The test will start when an arrow shows in the centre of 
the monitor pointing in one of four directions (up, down, left and right) that matched the four 
possible step directions (forward, backward, left and right). A word indicating a different direction 
will be written inside the arrow. Participants will be instructed to ‘Step by the word’ and will have 
to inhibit the response indicated by the arrow’s orientation. Four practice trials are not included in 
the score and 20 trials will be administered randomly by the directions of word and orientation. 
The average time (ms) and number of errors will be recorded.(51)  

 
14 
Fall risk assessment will be assessed using the Physiological Profile Assessment (PPA). 
The PPA consists of five assessments including edge contrast sensitivity, lower limb 
proprioception, lower limb strength, simple hand reaction time, and postural sway. Briefly, edge 
contrast sensitivity will be assessed using the Melbourne Edge Test, which presents 20 circular 
patterns containing edges with reducing contrast. Correct identification of the orientation of the 
edge on the patches provides a measure of contrast sensitivity in decibel units. Lower lime 
proprioception will be assessed by instructing seated participants with eyes closed to align their 
lower limbs on either side of a vertical clear acrylic sheet inscribed with a protractor and placed 
between their legs. Any difference in matching the great toes on either side of the acrylic sheet 
will be measured in degrees. Lower limb strength will be measured using a spring gauge. 
Participants will be asked to extend their leg against the spring gauge while seated with the hip 
and knee joint angles positioned at 90°. Maximal force will be recorded in kilograms. Simple hand 
reaction time will be measured using the modified computer mouse connected with light 
stimulation system. Participants will be asked to press the mouse with their finger as quickly as 
possible in response to a light stimulus. The response data will be recorded in milliseconds. 
Postural sway will be measured using a swaymeter that measures displacements of the body. 
Participants will be instructed to stand as still as possible with the eyes open and closed on a firm 
surface and on a piece of medium-density foam rubber while wearing the sway meter at waist 
level. The sway area in the 30 second period in each condition will be recorded in square 
millimeters.(52) 
Secondary outcome measures 
• Physical function 
Mobility will be measured using the Timed Up and Go Test (TUG). Participants will be 
instructed to rise from a standard chair with arms, walk a distance of three metres at usual pace, 
turn around, walk back to towards the chair, and sit down again. The time in seconds will be 
recorded beginning at the instruction “go” and stopping when the participant is seated. One 
practice trial is not included in the score and therefore the mean of 2 trials will be calculated and 
used for statistical analysis.(53) 
Dual task test will be assessed using TUG test combined with a verbal fluency task by 
naming animals. Participants will be instructed to rise from a standard chair with arms, walk a 
distance of three metres, turn around, walk back to towards the chair, and sit down again. In the 

 
15 
meantime, participants will have to name as many animals as they can. The time to complete the 
TUG will be recorded in seconds. The mean of 2 trials will be calculated and used for statistical 
analysis.(54-55) 
Lower extremity functioning will be assessed using the Short Physical Performance Battery 
(SPPB). The scores range from 0 to 12 (higher score indicating better performance) and are based 
on performance on three tasks including gait speed, chair stand, and static standing balance with 
different three standing positions.(56) 
• Cognitive function 
Executive function will be assessed using Trail-Making Test (TMT) Part B and the 
Controlled Oral Word Association test (COWAT). For TMT Part B, participants will be instructed 
to draw a line to connect consecutive numbers in numerical order and letters in alphabetical order 
in an alternating sequence (e.g., 1–A–2–B–3) as quickly and correctly as possible.(57) For the 
COWAT, participants will have to generate as many words as possible in a 60s timeframe starting 
with F, then A, then S. The score will be calculated by the number of words correctly iterated.(58) 
Attention and processing speed will be assessed using Trail-Making Test (TMT) Part A 
and the digit symbol Substitution. For TMT Part A, participants will be instructed to draw a line 
to connect consecutive numbers in numerical order as quickly and correctly as possible (e.g., 1–
2–3).(57) For the digit symbol substitution, participants will be instructed to match symbols to 
numbers according to a key located on the top of the paper test. Participants will have to copy the 
symbol into spaces below a row of numbers. The score will be calculated by the total number of 
correct symbols within the allowed time, usually 90 to 120 seconds.(59) 
Short-term auditory memory and working memory will be measured using the two parts of 
the Digit Span test: Digits Forward and Digits Backward. These will be administered separately. 
The digits will be presented at a rate of one per second. In Digits Forward (DSF), the patient is 
required to repeat the digits in the same order as presented. In Digits Backward (DSB), the patient 
is required to repeat the digits in reverse order. Participants will listen to a series of numbers 
presented at 1 number per second and repeat them either in the same order (DSF) or in reverse 
(DSB). For example, after hearing “6, 9, 4, 7,” participants will repeat “6, 9, 4, 7” (DSF) or “7, 4, 
9, 6” (DSB). Numeric sets will range from 2 to 10 digits. Each set will be tested three times. If 
participants correctly recall the sequence at least twice, they will pass that set. Failure to do so will 
result in stopping the test.(60) 

 
16 
Semantic fluency will be assessed using the animals naming test. Participants will be asked 
to generate as many animals as they can within 60 second. The total score will be calculated from 
the maximum number of animals listed.(61) 
The modified switching verbal fluency test (mSVF) will be a cognitive flexibility test. In 
this test, participants will be required to alternately present words from two categories, fruits and 
animals, as many as possible within a 1-minute period. The researcher will record the correct word 
count for each category.(62) 
• Psychological function 
Anxiety symptoms will be assessed using Goldberg Anxiety Scale (GAS). The GAS 
consists of 9-item for self-rating of anxiety experienced in the past month which includes affective 
and somatic symptoms of anxiety. The score will be rated as yes (1) or no (0) answers with a total 
score ranging from 0 to 9 which higher scores substantially increase the probability of a significant 
anxiety disorder.(63)  
Symptoms of depression will be assessed using Thai Geriatric Depression Scale (TGDS). 
The short form of TGDS is a 15-item self-report questionnaire that inquiries about depressive 
emotion in daily situations experienced in the past week. Participants will rate each item as yes or 
no,   scores range from 0 to 15, with higher scores indicating greater symptom severity.(64-66)  
Fear of falling will be assessed using short Falls Efficacy Scale international (Short FES-
I). The Short FES-I version which is an interview-based questionnaire contains 7 activities of daily 
living. The level of concern about falling through a combination of pictures and matching short 
phrases is scored on a 4-point scale (1 = not at all concerned to 4 = very concerned). The total 
score ranges from 7 to 28.(67) 
• Neurophysiological assessment 
Participants will perform two tasks: 1) electroencephalogram (EEG) recordings during 
resting-state, and 2) event-related potentials (ERPs) recordings during Go/No-go task in response 
to visual stimuli. In the resting-state, each participant will seat in a comfortable chair in a relaxed 
position during the EEG measurement, which consists of 5-minute session for eyes opened and 
eyes closed conditions. The EEG signals will be recorded during resting state using an 
eegoTMmylab ANT Neuro (32-electrodes EEG cap) as showed in Figure 3. The EEG recording 
will use a sampling rate of 512 Hz and a notch filter of 50 Hz. A software filter will set to bandpass 

 
17 
with a low pass of 0.3 Hz and a high pass of 100 Hz. The impedance of the electrode-skin interface 
will keep below 20kΩ, as recommended in prior scholarship.(68) The EEG instrument consisted of 
32 channels (Figure 4) at the recording of position includes Fp1, Fpz, Fp2, F7, F3, Fz, F4, F8, FC5, 
FC1, FC2, FC6, T7, T8, C3, Cz, C4, CP5, CP1, CP2, CP6, P3, P7, Pz, P4, P8, POz, O1, Oz, O2, M1, M2, 
CPz (reference electrode), and AFz (ground electrode). 
 
Figure 2. The EEG system using an eegoTMmylab ANT Neuro 
 
Figure 3. Montage of the EEG system in the experiment, 32 electrodes 
- 
Participants will perform the event-related potentials (ERPs) recordings during Go/No-
go task (using 4 images) in response to visual stimuli. Participants will have the brain 
activity measured with an electroencephalography (EEG) cap while performing an 
image-viewing task. The cap will record the brain signals as participants view images 
and respond by pressing a pedal with their's dominant foot. Participants will complete 
practice pedal presses to become familiar with the response before the actual test. When 

 
18 
participants see image “(1)” or “(3)” they should press the pedal; when they see image 
“(2)” or “(4)” they should not press the pedal. The picture stimuli will present in random 
order during each trial, and each trial lasted 2-minutes. Participants will give a 5-minute 
rest between trials, and the duration of the two experiments was 40 minutes. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 4. The two insets show the stimuli used in the experiment for image 1 and 3 (O) 
and No-go for image 2 and 4 (X) 
 

 
19 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 5. ERPs recording by using foot switch during Go/No/go task 
 
EEG data analysis 
In resting-state, the absolute power spectrum of the respective frequency bands derived by 
Fast Fourier Transformation (FFT) will express as follows: delta (0.5-4 Hz), theta (4.5-8 Hz), alpha 
(8.5-13 Hz), and beta (13.5-30 Hz) wave ranges. The EEG data will separate in six brain areas 
with corresponding electrodes which demonstrated both the functional and anatomical aspects of 
the brain's organization. There are the pre-frontal, frontal, central temporal parietal, and occipital 
areas. The ERPs recordings, and peak amplitudes and latencies of the N2 and P3 waves will 
measure over the midline occipital (Oz), parieto-occipital (POz), midline parietal (Pz), midline 
central (Cz), and midline frontal (Fz) electrode sites. The peak amplitudes (measured with respect 
to 100 millisecond pre-stimulus baseline) and latencies of major ERPs component will calculate 
for each participant in the following time window: N2 within 200–300 ms(69), and P3 within 250–
500 ms.(70) The peak amplitude (μV) will define as the voltage difference between the baseline and 
the negative- and positive-going peak of the ERPs waveform after stimulus presentation. The peak 
latency (ms) will define as the time from stimulus onset to the point of the maximum negative and 
positive amplitude of the N2 and P3 waves respectively.  
Statistical analysis for neurophysiological assessment 

 
20 
All statistical tests will be performed in Jamovi, and data visualization within the R 
statistical framework (version 4.0, R Foundation for Statistical Computing) and ASA software. 
Three metrics will of interest in this study; EEG during resting-state, ERPs during Go/No-go tasks, 
and physical response when participants push down with their leg during Go/No-go tasks. To 
assess the normality of the data, Shapiro-Wilk tests will initially apply to the data. Therefore, a 
generalized linear mixed modelling (GLMM) will be used to report the linear predictor between 
EEG during resting-state in brain areas (random), and pre-post recording (fixed) effects. One-way 
ANOVA will be used to compare pre-post recording with respect to peak amplitude and latency 
of N2 and P3 of the ERPs recording, response time, and the number of correct responses. The 
significance level will be set at ρ<0.05. 
• Physical activity 
The Physical Activity Scale for the Elderly (PASE) Thai-version evaluates physical 
activity through 10 questions covering walking, exercise, household chores, and work. Participants 
will report activity type, frequency, and duration over the past week. Scores are calculated by 
multiplying activity frequency and duration by assigned weights. Activities like chores and work 
are scored based on average daily hours, adjusted by weights; sedentary tasks score 0. The total 
score, ranging from 0 to 400, excludes sitting activities.(71) 
• Quality of life measure 
The participants' QOL will also be evaluated by using the WHOQOL-BREF-Thai 
questionnaire that can be assessed by self-report. In situations that the participants cannot read, the 
assessor will read for them, and they will have to choose the answer by themselves. The 
WHOQOL-BREF questionnaire has two types of questions: perceived objective and self-report 
subjective, and it includes four components of well-being: physical, psychological, social, and 
environmental. Each item is scored from 1-5. This Thai version has a good internal consistency 
with Cronbach’s alpha 0.84.(72)  The higher score indicates better QOL. 
• Number of fall events 
Each participant will be given weekly fall diaries to mark any falls during the study period. 
A fall is defined as “an unexpected event in which the person comes to rest on the ground, floor, 
or lower level”. If fall data is not received, telephone calls will be used to obtain fall data.  
• System usability (intervention group only) 

 
21 
At the completion of the Smart±step training (3 months and 6-months), participants will 
rate the usability of the Smart±step training using the System Usability Scale (SUS): SUS scores 
of 50–70 are acceptable, 71–85 are good to excellent, >85 are excellent usability, and <50 are 
considered unacceptable.(73-74) 
• Adherence and Adverse Events 
All participants will be instructed to complete a logbook immediately after each exercise 
session to ensure data accuracy. Adherence to the intervention will be calculated as the percentage 
of Smart±Step sessions attended, using the formula: ((n/24 sessions) x 100). Any adverse events 
occurring during the study, such as injuries, falls, fatigue, or other exercise-related issues, will be 
documented. Furthermore, participants will be asked about their training experiences and any 
health issues at every follow-up point throughout the study. They will also be encouraged to 
contact the research team at any time with questions or concerns. 
• Enjoyment 
Enjoyment during engaging in the Smart±Step training exercise will assess using Physical 
Activity Enjoyment Scale (PACES) Enjoyment Scale (PACES). The PACES is an 8-item scale 
questionnaire that measures the level of enjoyment using a 7-point Likert scale ranging from 1 
(strongly disagree) to 7 (strongly agree). The scores for enjoyment were obtained through the sum 
of PACES scores. A higher score indicates a greater level of enjoyment. 
Randomisation and concealment 
Randomisation will occur after baseline assessment (Figure 1) and will be stratified by site. 
Concealed randomisation will be performed by a person independent of the study using established 
randomisation software at Faculty of Physical Therapy. 
Cognitive-motor training Intervention 
Participants allocated to the intervention group will be provided with the Smart±step 
system and recommended to exercise at least 120 minutes per week for 24 weeks, which is a best 
practice recommendation for fall prevention exercise program.(75) The Smart±step system uses a 
floor step mat and small computer installed in the participant’s home. The program is performed 
in standing and participants need to step onto targets using the wireless electronic floor step mat. 
The Smart±step cognitive-motor training has built-in motivating features and provides instant 
feedback on performance. To ensure a variety of games are played, participants will be required 

 
22 
to play a core game on each training day, this will unlock their other games. The exergame can be 
tailored to individual by offering five different levels of challenge. Medals are awarded based on 
the number of minutes played each week (bronze for >80min, silver for >100min, gold for 
>120min) to encourage adherence. To facilitate motivation and progression, participants will 
receive feedback after each game; that is, the score for the game just completed and their highest 
score for that game to date.  
Within 2 weeks of randomisation, intervention participants will receive an initial home 
visit from a physiotherapist who will install the equipment in an appropriate location in the home 
and provide training. The training equipment will consist of the smart±step system and step mat 
to interface with their television screen (or provided a monitor). The participants will be asked to 
play the games while standing and taking quick and appropriate steps on the mat. The 
physiotherapist will discuss goal setting and barriers to training with participants to facilitate 
adherence and exercise progression. Participants game level will be prescribed depending on their 
performance and will be encouraged to progress every two weeks to provide a more challenging 
program. Participants will be provided with all equipment at no cost during the 3-month exercise 
period as well as an instruction manual containing safety precautions.  
 
 
 
 
 
 
Figure 6. Smart±step motor-cognitive training 
Monitoring  
The adherence of individual’s program will be transferred from participants’ smart±step 
computers to a secure server at Faculty of Physical therapy, Mahidol University. Participants 
adherence will be monitored by study staff, they will be contacted individually by telephone to 
encourage adherence if the number of minutes played each week < 80 minutes. The phone call 
will aim to review goals and address barriers to training. A second home visit will be provided at 

 
23 
4 weeks to monitor safety, progress and address any issues. Telephone support and additional 
home visits will be provided upon request and a final home visit will occur on completion of the 
3 month program to collect equipment and assess for outcome measures. 
Control group 
The control group will receive usual care and existing healthy living information (Blue 
book) https://eh.anamai.moph.go.th/web-
upload/10x2f8665bc5c6742a30312c81435ca284e/202201/m_news/33518/207917/file_download
/7dc90c0368663c51b2fdfeabc3a88a7d.pdf 
 
Safety  
We are not expecting any safety concerns directly related to the intervention. The 
hardware will be installed in a safe place within the home by a trained research assistant. 
However, there is a small risk of injury during physical assessment. However, this is unlikely as 
the assessments will be undertaken by trained research staff and all of the assessments are 
commonly used in research and clinical practice.  
 
Sample size calculation 
The sample size calculation for this study was based on the Stroop Stepping Test (SST) 
from previous research, with an effect size (f²) of 0.15.(51) The calculation used a two-tailed t-test 
(Linear multiple regression: fixed model, single regression coefficient) and included four 
covariates: age, gender, education, and intervention. The statistical power was set at 80%, and the 
Type I error rate was set at 5%. The resulting sample size required for this study is 55 participants, 
which would allow for the detection of a 15% change in cognitive and motor skills test outcomes. 
Additionally, to account for potential dropouts (estimated at 20% of participants), the total sample 
size was increased to 70 participants, with 35 participants per group. The sample size calculation 
was performed using the G*Power 3.1 software. 
 

 
24 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistical analysis 
Demographic variables will be analysed for between-group differences using independent 
samples t-tests for continuous variables and chi-square tests for nominal variables. Mann Whitney 
U test will allow to use for a nonparametric test. Generalised linear models were used to compare 
between-group differences in the outcome measures at 3-, 6- and 12-months while adjusting for 
baseline scores. Per-protocol and intention-to-treat (ITT) analyses will be completed. Missing data 
will be imputed using the following methods: participants who are physically unable to complete 
a physical test and cognitively unable to complete a cognitive test will be given a score of 3SD 
above or below the baseline mean (whichever indicates poorer performance) as these data are not 
missing at random. For the remaining missing data Little’s Missing Completely at Random test 
will be used to determine if the data is missing at random, if it is estimated marginal means single 
imputation will be used as long as the values are missing for no more than 10% of the cases. If the 
missing completely at random test is not satisfied multiple imputation will be used. Significance 
will be two sided and will set at P < .05. All statistical analyses will conduct using SPSS.  
Project timeline 
Table 2 Project timeline 
 
Year 1 (2025) 
Year 2 (2026) 
Year 3 (2027) 

 
25 
1 
2 
3 
4 
1 
2 
3 
4 
1 
2 
3 
4 
Staff recruitment & training  
 
 
 
 
 
 
 
 
 
 
 
 
Ethical approval  
 
 
 
 
 
 
 
 
 
 
 
 
System refinement  
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment and assessment  
 
 
 
 
 
 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
Three month reassessments 
 
 
 
 
 
 
 
 
 
 
 
 
Six month reassessments  
 
 
 
 
 
 
 
 
 
 
 
 
Twelve months follow-up completed   
 
 
 
 
 
 
 
 
 
 
 
Data entry & analysis  
 
 
 
 
 
 
 
 
 
 
 
 
Manuscript preparation and 
submission 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outcomes and significance 
This work aims to develop interventions to specifically address physical, cognitive and 
psychological contributions to falls in people with MCI. More than 60% of community-dwelling 
older people with cognitive impairment fall each year. Yet, the evidence for effective fall 
prevention interventions is currently lacking in people with cognitive impairment, particularly in 
older people with MCI. Falls in people with cognitive impairment have more serious consequences 
when compared to their cognitively healthy peers, for example, they are more likely to result in 
injuries (hip fractures and head injury), loss of function, placement in residential care and death. 
This work aims to develop successful and cost-effective fall risk preventative strategies with the 
ultimate objective of improving the quality of life and health and wellbeing of this growing 
population. Combining cognitive and physical training will not only prevent falls but also help to 
improve functional ability and reduce the proportion of individuals transitioning to dementia. 

 
26 
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MU-CIRB 
Mahidol University Central Institutional Review Board (MU-CIRB) 
Version Date 10/07/2020 
Informed Consent Form 
Page 1 of 2  
For MU-CIRB Staff    
       Protocol No.: MU-CIRB 2025/080.1402               COA(T) No. MU-CIRB 2025/147.0205 
 
Informed consent form version 11/12/2024   
 
 
                                                         
 
Informed Consent Form 
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Date................. /..................../............... 
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road/street......................................sub-district/tambon..................................... district/amphur........................................ 
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I hereby express my consent to participate as a subject in the research project entitled “Cognitive–Motor 
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I therefore consent to participate as a subject in this research project. 
On the condition that I have any questions about the research procedures, or on the condition that I suffer from 
an undesirable side effect from this research, I can contact Lect. Dr. Thanwarat Chantanachai via phone number +66 
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On the condition that I am not treated as indicated in the information sheet distributed to subjects, I can contact 
the Chair of Mahidol University Central Institutional Review Board, (MU-CIRB) at the office of the President, Mahidol 
University, Tel 66-2-8496224-5, Fax 66-2-849-6224. 
 
 
 

MU-CIRB 
Mahidol University Central Institutional Review Board (MU-CIRB) 
Version Date 10/07/2020 
Informed Consent Form 
Page 2 of 2  
For MU-CIRB Staff    
       Protocol No.: MU-CIRB 2025/080.1402               COA(T) No. MU-CIRB 2025/147.0205 
 
Informed consent form version 11/12/2024   
 
 
                                                         
 
I am aware of my right to further information concerning benefits and risks from the participation in the 
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