Aging and Task-Specific Training to Reduce Falls
Phase: PHASE1
Conditions: Fall Prevention
Sponsor: University of Illinois at Chicago

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Aging and Task-Specific Training to Reduce Falls 
 
 
Principal Investigator: 
Dr. Tanvi Bhatt, Assistant Professor, Department of Physical Therapy, 
Room 415, AHSB, 1919 W. Taylor St., M/C 898 
University of Illinois, Chicago, 60612. 
(312) 355-4443 
tbhatt6@uic.edu 
Study Location(s): Rooms 415, 416, B-56, Department of Physical Therapy,  
AHSB, 1919 W. Taylor St., University of Illinois, Chicago, 60612 
 
Sponsor: National Institutes of Health 
 
Version: 4 
Date: 02/28/25 

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TABLE OF CONTENTS 
Page 
Table of Contents ............................................................................................................ 2 
List of Abbreviations ........................................................................................................ 3 
1.0 Project Summary/Abstract ................................................................................... 4 
2.0 Background/Scientific Rationale ......................................................................... 4 
3.0 Objectives/Aims .................................................................................................... 5 
4.0 Eligibility ................................................................................................................ 6 
4.1 Inclusion Criteria ............................................................................................. 7 
4.2 Exclusion Criteria ............................................................................................ 7 
4.3 Excluded or Vulnerable Populations ............................................................. 7 
5.0 Subject Enrollment................................................................................................ 9 
6.0 Study Design and Procedures ........................................................................... 10 
7.0 Expected Risks/Benefits ..................................................................................... 17 
8.0 Data Collection and Management Procedures ................................................. 20 
9.0 Data Analysis ....................................................................................................... 22 
10.0 Quality Control and Quality Assurance ............................................................. 22 
11.0 Data and Safety Monitoring ................................................................................ 22 
12.0 Statistical Considerations .................................................................................. 23 
13.0 Regulatory Requirements ................................................................................... 24 
13.1 
Informed Consent ..................................................................................... 24 
13.2 
Subject Confidentiality ............................................................................. 24 
13.3 
Unanticipated Problems .......................................................................... 24 
14.0 References ........................................................................................................... 26 
Appendices ................................................................................................................... 30 
 

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LIST OF ABBREVIATIONS  
 
COI 
 
 
Conflict of Interest 
DHHS  
 
Department of Health and Human Services 
DMC  
 
Data Monitoring Committee 
DSMB  
 
Data and Safety Monitoring Board 
DSMP  
 
Data and Safety Monitoring Plan 
FERPA 
 
Family Educational Rights and Privacy Act 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IBC 
 
 
Institutional Biosafety Committee 
ICD 
 
 
Informed Consent Document 
ICH 
 
 
International Conference of Harmonization 
IDE 
 
 
Investigational Device Exemption 
IDS 
 
 
Investigational Drug Service 
IND 
 
 
Investigational New Drug  
IRB 
 
 
Institutional Review Board 
LAR  
 
Legally Authorized Representative 
OHRP  
 
Office of Human Research Protections 
OPRS  
 
Office for the Protection of Research Subjects 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PPRA  
 
Protection of Pupil Rights Amendment 
QA/QI  
 
Quality Assurance/Quality Improvement 
SAE  
 
Serious Adverse Event 
SOP  
 
Standard Operating Procedure 
 
 

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1.0 
Project Summary/Abstract 
The proposed study employs a randomized, controlled design to assess the immediate 
and long-term effects of task-specific balance training for reducing environmental falls in 
at-risk community-dwelling older adults. >33% of older adults fall at least once each 
year1-5, leading to serious injuries (e.g., hip fractures, head injuries) and comorbidities 
(e.g., Alzheimer’s disease and related Dementias)5-9. Most falls occur due to 
environmental disturbances which cause a loss of balance while walking (i.e., slips, 
trips)10,11. Overground perturbation training (repeated exposure to unpredicted 
perturbations) improves both volitional/anticipatory and reactive balance control and 
reduces real-life falls among older adults12-16. However, overground perturbation training 
is not suitable for routine clinical application due to its complex design, space, and 
technology requirements. An alternative method for delivering perturbation training is 
commercial treadmill systems, which not only can enhance fall-resisting skills but are 
more feasible for community-translation17,18. However, the equipment is costly and the 
translational effectiveness of treadmill perturbation training for reducing falls in 
community ambulatory older adults is lesser than overground training, probably as it 
mainly only entrains reactive balance control. Falls may also occur due to deficits in 
volitional balance control which affect gait stability during daily living. Training 
paradigms focused on improving volitional balance control have primarily comprised of 
conventional balance exercises delivered as a part of physical rehabilitation; however, 
conventional balance exercises generally do not translate to improvements in reactive 
balance control when exposed to an unpredicted external perturbation and have limited 
effects on reducing real-life falls19,20. A fall prevention intervention that targets both 
volitional and reactive balance domains could more effectively reduce falls than existing 
paradigms which only train a single domain (e.g., treadmill perturbation training: 
reactive-dominant, or conventional balance: volitional-dominant). We have developed a 
novel task-specific balance program that includes exercises specific to slips and trips 
and requires little set-up and equipment, making it a cost-effective, feasible and 
accessible fall prevention intervention. We will compare the effects of 8 weeks (16 
sessions) of task-specific balance training with established fall prevention paradigms 
including treadmill perturbation training and conventional balance training. We will 
examine the immediate effects of task-specific balance training on reactive balance 
(Aim 1) and volitional balance (Aim 2). Additionally, we will evaluate the longer-term 
retention (18 months) of task-specific balance training and effects on real-life falls and 
balance confidence (Aim 3). In an exploratory aim, will also examine the neuromuscular 
adaptations induced through training using simulation techniques (Aim 4). If successful, 
our novel intervention can be implemented as a feasible, safe, and effective fall-
prevention intervention and has large potential for direct dissemination to clinical 
settings.  
 
    
 
 

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2.0 
BACKGROUND/SCIENTIFIC RATIONALE  
Falls occur in >30% of older adults each year1-5, leading to ~2.8 million hospital 
admissions5-9, 32,000 deaths, and $50 billion in medical costs21. Further, older adults 
with fall history are 3x as likely to experience another fall within the same year22. >60% 
falls occur due to environmental disturbances which cause loss of balance while walking 
(i.e., slips, trips)10,11. We have developed an innovative overground perturbation-based 
training paradigm which delivers repeated slip-like disturbances and conducted 
systematic theoretical and empirical studies which establish its positive effects on 
volitional/anticipatory and reactive balance control12-16. Slip training improves the ability 
to restore center of mass stability (influenced by protective stepping) and limb support 
(influenced by net extensor torque)23-25; these adaptations can be retained for at least 
one year, and reduce long-term real-life falls in older adults16. Our recent study 
(R01AG050672) showed that mixed training (slip and trip training) resulted in greater 
retention of stability control and lower overall real-life fall rates26. Despite its robustness 
for acquiring fall-resisting skills, overground perturbation training is not suitable for 
routine clinical application due to its complex design, space, and technology 
requirements.   
An alternative method for perturbation training delivery is via commercial 
treadmill systems, which not only enhance fall-resisting skills but are more feasible for 
community-translation. However, the equipment is costly and the translational 
effectiveness of treadmill perturbation training is lesser than overground training for 
reducing falls in community ambulatory older adults17,18, probably as it mainly only 
entrains reactive balance control. But falls are heterogeneous in nature and may also be 
caused by decrements in volitional balance control which affect gait stability during daily 
living, especially for at-risk older adults. Training paradigms focused on improving 
volitional balance have primarily comprised of conventional balance exercises; however, 
such training does not translate to improvements in reactive balance and thus has 
limited effects on reducing falls during daily living19,20. A fall-risk intervention that targets 
both volitional and reactive balance domains could more effectively reduce falls than 
existing paradigms which only train a single domain (i.e., treadmill-perturbation training 
(reactive-dominant), or conventional balance training (volitional-dominant)). Further a 
fall prevention intervention which addresses other barriers of perturbation-based training 
(i.e., fear of facing falls and chances of adverse effects) would be safer and more 
acceptable for clinical translation. 
  
3.0 
Objectives/Aims 
 
For this project, we have developed a novel task-specific balance training program that 
includes functional exercises specific to slips and trips and requires little set-up and 
equipment, making it a cost-effective, feasible and accessible fall prevention 
intervention27. The purpose of this study is to determine efficacy of this program in older 
adults who are ‘at-risk’ of falling, compared to treadmill-perturbation and conventional 
balance interventions. Our specific aims are listed below: 
Aim 1: To examine immediate effects of 8 weeks of task-specific balance training on 
reactive balance in at-risk community-dwelling older adults. 

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Hypothesis 1: Task-specific balance training will induce greater improvements in 
reactive center of mass stability and limb support than treadmill-perturbation and 
conventional balance training, resulting in fewer laboratory falls on novel overground 
slips and trips immediately post-training.  
 
Aim 2: To examine immediate effects of 8 weeks of task-specific balance training on 
volitional balance in at-risk community-dwelling older adults.  
Hypothesis 2: Task-specific balance training will induce greater improvements in 
volitional balance control than treadmill-perturbation and conventional balance training, 
resulting in higher scores on the Functional Gait Assessment immediately post-training.  
 
Aim 3: To examine longer-term effects of 8 weeks of task-specific balance training on 
real-life fall reduction and falls efficacy in at-risk community-dwelling older adults. 
Hypothesis 3: Long-term retention of improvements in reactive and volitional balance 
control induced by task-specific balance training will result in fewer real-life falls and 
higher falls efficacy than treadmill-perturbation and conventional balance training 18-
months post-training.   
 
Exploratory Aim 4: To validate whether task-specific balance training induces 
neuromuscular adaptations to muscle synergies during unperturbed and perturbed 
walking that may serve as causative factors to reduce environmental falls.  
 
4.0 
Eligibility 
 
Participant recruitment. Potential participants will be recruited by posting flyers, 
sending e-mails and presenting at local health forums, community senior centers, 
retirement communities, independent living facilities, and wellness centers. Potential 
participants will also be recruited by posting study flyers on the Cognitive, Motor, and 
Balance Rehabilitation lab website (https://cmbrl.ahs.uic.edu), or on the lab Facebook 
and/or Instagram accounts. The Research Match Registry supported by the Center of 
Clinical and Translational Research and the Center for Research on Healthy Aging at 
UIC will also be used. Direct referrals by geriatricians and other health-care practitioners 
will also be included for screening. Newspaper, radio, television, and internet 
advertising will be done. Participants from previous studies will not be included.  
 
Potential participants will make contact with the research team if they are interested in 
participating in the study, at which point we will initially screen them over the phone 
using the telephone screening form. If participants are initially eligible to participate in 
the study via phone screening, we will then schedule them for an in-person screening 
visit. (See details of specific inclusion and exclusion criteria for the telephone and in-
person screening visits under participant screening).  
 
Participant screening (inclusion and exclusion criteria). This study will enroll older 
adults (ages 60-90 yrs) who are identified as ‘at-risk’ of falling. Participant eligibility will 
initially be assessed over the phone, which will take approximately 10 minutes. Upon 
passing the phone screening, the remaining eligibility criteria will be assessed in-person 

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on the participant’s first visit to the laboratory after they sign the consent. The in-person 
screening will take about 1 hour. The specific inclusion/exclusion criteria assessed at 
each level of screening are listed below. 
 
4.1 Telephone Screening Inclusion Criteria 
 Age: 60-90 years. 
 Absence of any acute or chronic neurological (Stroke, Parkinson’s 
disease, Alzheimer’s disease), cardiopulmonary, musculoskeletal, or 
systemic diagnosis. 
 No recent major surgery (< 6 months) or hospitalization (< 3 months). 
 Not on any sedative drugs. 
 Can understand and communicate in English.  
 Can walk without an assistive device for at least 1 block to ensure 
independent functioning. 
 
4.2 Telephone Screening Exclusion Criteria 
 Complaints of shortness of breath or uncontrolled pain (>3/10 on visual 
analogue scale (VAS)) at rest to avoid complications/injuries during 
testing/training. 
 Uncontrolled (not under any medications) hypertension to avoid 
cardiovascular complications during testing/training.  
 Self-reported history of bone fracture in the last six months to avoid 
complications/injuries during testing/training. 
 Self-reported disability (with or without assistive device) to ensure 
independent functioning. 
 Weight >220 lbs (harness weight threshold). 
 
4.3 In-Person Screening Inclusion Criteria 
 Identification of ‘at-risk’ older adults: We will only include older adults 
who are identified as ‘at-risk’ of falling based on two criteria. First, 
participants will be identified as ‘at-risk’ if they self-report experiencing at 
least one or more fall in the past 12 months. We will ask participants if 
they have experienced a fall in the past year during their telephone 
screening, and confirm this information when they come for their in-person 
screening. Secondly, participants will be identified as ‘at-risk’ using fall risk 
prediction models which our lab has developed (called the Fall Risk 
Assessment and Testing Technology (FRATT). Using these models, we 
can predict the risk of falls in the laboratory (when exposed to slip-like or 
trip-like perturbations) and in real-life based only on a video of a 
participant walking for about 10 seconds. We have published papers in 
which we tested the accuracy of these models, and found that they can 
predict fall risk with greater than 80% accuracy28 29. We will ask 
participants to walk for about 10 seconds while we take a video of them on 
a tablet, and the FRATT system will immediately output their fall risk 
score. If participants receive a fall risk score of >50% using these models, 

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then they will be identified as ‘at risk.’ Note: To be considered ‘at-risk’ of 
falling and included in the study, participants only need to meet ONE of 
the above listed criteria (i.e., either report ≥1 fall in the past 12 months OR 
receive a fall risk prediction score of >50% using our models).  
 
Visual acuity greater than or equal to 20/40 with or without corrective 
lenses30 to ensure intact vision. 
 
4.4 In-Person Screening Exclusion Criteria 
 Participants will not proceed with the study if any of the following occurs at 
baseline measurement: 1) Heart Rate >85% of age-predicted maximal 
heart rate (HRmax) (HRmax = 220 – age), 2) systolic blood pressure 
(SBP) > 165 mmHg and/or diastolic blood pressure (DBP) > 110 mmHg 
during resting). If participants have a blood pressure outside of the cutoff 
ranges, we will immediately provide them with a copy of their blood 
pressure reading and discuss with them why they were excluded from the 
study. Participants will be encouraged to follow up with their physician 
regarding their blood pressure. 
 Participants will be excluded from the study if they are not independent 
community ambulators. We are aiming to include older adults who have 
higher fall risk but are still independent community ambulators, as these 
individuals are at the greatest risk of falling from external perturbations 
(e.g., slips, trips) in the community. We will determine ambulatory status 
using the following three criteria:  
o Participants will be excluded if they are not able to stand for 5 
minutes and walk for 10 m without an assistive device. Each trial of 
testing/training requires independent standing and walking for at 
least 10 meters.  
o Participants will be excluded if they receive a score of <40/56 on 
the Berg Balance Scale. Older adults who receive a score less than 
40 on the Berg Balance Scale would be at extreme risk of falling 
even just while standing and would likely not be able to perform 
training exercises without falling. These individuals are likely to rely 
on an assistive device and be only home-ambulators rather than 
community-ambulators. 
o Participants will be excluded if they score <4 on the Functional 
Ambulation Category (FAC). The FAC is a 6-point functional 
walking test (possible scores 0-5) that evaluates ambulation ability. 
A score of less than 4 would indicate that participants cannot 
ambulate independently without physical assistance or supervision.   
 Complaints of shortness of breath, or uncontrolled pain (more than 3 out 
of 10 on Visual Analogue Scale), or if pulse oxygen drops less than 92% 
on the six- minute walk test (for endurance) to ensure that the participant 
can effectively participate without discomfort or injury during testing and 
training. If participants have low pulse oxygen at screening, we will not 
proceed with screening/testing, we will advise them to follow up with their 
physician, and they will be excluded from the study. 

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 
Subjects with severe osteoporosis (Tscore < –2) 31 measured via Achilles 
heel bone density scan (Lunar Achilles Tendon (EXPII)). This is to prevent 
potential risk of fractures, musculoskeletal injuries and to ensure patient 
safety. If we observe a T score indicating osteoporosis, participants will be 
provided with a copy of screening results describing why they were 
excluded from the study and will also be encouraged to follow-up with their 
physician. 
 Presence of cognitive impairment, identified by a score of less than 25 on 
the Mini Mental State Exam32. If participants receive a score indicative of 
cognitive impairment, we will provide them with a copy of their score and 
discuss with them why they were excluded from the study. Participants will 
be encouraged to follow up with their physician regarding their score.  
 
4.5 Excluded or Vulnerable Populations 
 Participants will be excluded if they are unable to understand or 
communicate in English as the entire training and testing protocol will be 
provided in English.   
 
The inclusion and exclusion criteria assessed during telephone screening and in-person 
screening are summarized in the tables below. 
 
Telephone Screening 
Inclusion Criteria 
Age 60-90 years 
Self-reported medical conditions 
 No acute/ chronic disease 
 No recent major surgery (< 6 months) 
 No recent hospitalization (< 3 months) 
 Not on sedative drugs 
Can understand and communicate in English 
Can walk without an assistive device for at least 1 block 
Exclusion criteria 
Complaints of shortness of breath or uncontrolled pain (>3/10 on visual analogue scale) 
Uncontrolled (not under any medications) hypertension 
Self-reported history of bone fracture (in the past 6 months) 
Self-reported disability (with or without assistive device) 
Body weight > 220 lbs 
In-Person Screening 
Inclusion Criteria 

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5.0 
Subject Enrollment 
We plan to screen up to n=523 participants, and we expect that up to 40% of 
participants will not meet the inclusion criteria. Potential participants who are interested 
in participating in the study will make contact with the research, and will then be 
screened over the phone to see if they meet the telephone screening 
inclusion/exclusion criteria. Participants who pass the in-person screening would then 
be scheduled for an in-person laboratory visit to complete the in-person screening 
protocol at Room 415, B56 or 725 of the College of Applied Health Sciences building. 
We plan to enroll a total of n=315 participants who will complete a baseline assessment 
and be randomly (through random number generator using excel) assigned into one of 
three groups. Group A will complete task-specific balance training (n=105), Group B will 
complete treadmill perturbation training (n=105), and Group C will complete 
conventional balance training (n=105). All groups will complete their respective trainings 
for 8 weeks (2x per week for a total of 16 sessions). Detailed descriptions of each type 
of training are provided in section 6, “Study Design and Procedures.”  
 
All participants’ information will be recorded in a database in the form of an excel sheet 
that will include the information of the participants eligible and those not eligible for 
study. For participants not eligible for the study, the reason for withdrawal or exclusion 
from the study participation as per the telephone screening will be recorded. An excel 
file would be maintained to document the results of participants’ initial telephone 
screening.   
   
6.0 
Study Design and Procedures 
Session 1: Subject Screening & Baseline Assessment (All Groups) (3 hours): 
Once included (as per inclusion criteria detailed above), all groups (A, B, and C) will 
undergo several clinical measures to assess their baseline function. We will measure 
‘At-risk’ Older Adults 
 Self-report of at least 1 or more falls in the past 12 months OR 
 Fall risk score >50% using our fall risk prediction models 
Visual acuity ≥20/40 with or without corrective lenses 
Exclusion criteria 
Heart rate >85% age-predicted maximal heart rate (220-age) 
Systolic blood pressure >165 mmHg and/or diastolic blood pressure >110 mmHg during rest 
Not an independent community ambulator 
 Cannot stand for 5 minutes and walk for 10 m without an assistive device 
 Score <40/56 on the Berg Balance Scale 
 Score <4 on the Functional Ambulation Category 
Shortness of breath or uncontrolled pain (>3/10) or if pulse oxygen drops below 92% on the 
six-minute walk test 
Severe osteoporosis (T-score <-2 on Achilles heel bone density scan) 
Presence of cognitive impairment (<25 on the Mini Mental State Exam) 

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basic demographics such as height, weight, years of education, current medications, 
and race/ethnicity. We will also assess peripheral sensation, range of motion, and lower 
limb strength. We will also assess participant’s balance control using the functional gait 
assessment (FGA) and the mini–Balance Evaluations Systems Test (mini-BEStest), and 
we will assess participant’s balance confidence using the Activities-Specific Balance 
Confidence Scale (ABC). The in-person screening and baseline assessment will take a 
total of 3 hours. Details of each baseline assessment are provided below: 
1) Peripheral Sensation: Application of 5.07 monofilament with 10g force to 10 
sites on the plantar surface of foot33,34. 
2) Range of motion: Assessed bilaterally via electronic goniometer for lower 
extremity (hip, knee, ankle). 
3) Strength: Participants asked to sit and stand from a chair as many times as 
possible in 30 seconds (Chair Stand Test)35. 
4) Functional Gait Assessment (FGA): The Functional Gait Assessment (FGA) is 
a clinical tool used to evaluate an individual's ability to perform various walking 
tasks, assessing gait stability and balance. It consists of 10 tasks that measure 
different aspects of gait, including walking on different surfaces, changing speed, 
and negotiating obstacles, with a maximum score of 30. 
5) Mini Balance Evaluation Systems Test (Mini-BESTest): The Mini BESTest 
consists of 36 tasks which assess different domains of balance control such as 
self-initiated movements, reactive balance control, and gait. The research scores 
the participant on each task ranging from 0 (severe impairment) to 3 (no 
impairment), resulting in a percentage score out of 108 points. Higher scores 
indicate better performance.      
6) Activities-Specific Balance Confidence Scale (ABC): The Activities-specific 
Balance Confidence (ABC) Scale is a self-reported questionnaire that assesses 
an individual's confidence in maintaining balance while performing various daily 
activities. It consists of 16 items, where respondents rate their confidence on a 
scale from 0% (no confidence) to 100% (complete confidence). 
 
Sessions 2-17: Training (All Groups) (1 hour per session, 2 sessions/wk, 8 wks) 
All participants will complete 8 weeks (2x/week, 16 sessions total) of an exercise 
intervention designed to improve their balance control, consisting of either task-specific 
balance training (Group A), treadmill perturbation-based training (Group B), or 
conventional balance training (Group C). Each group will have 105 older adults, and 
participants will be randomized into groups using a random number generator (0-2) in 
excel. The specific components of each type of training are described below.  
 
Task-Specific Balance Training (Group A): Participants in Group A will 
complete some exercises task-specific to slipping or tripping. Each session will 
begin with 10 minutes of warm-up/stretching exercises to prevent injury and 
strengthen 
postural 
muscles. 
Following 
this, 
participants 
will 
practice 
moving/controlling a slider plate with their foot on both sides, similar to how the 
plate will move when a slip is administered. These exercises will be completed 
with or without added weight on the slider plate as resistance. Additionally, 
participants will complete exercises where they have to stand/walk and step over 
an obstacle (similar to an object which they might trip over in daily life). During 
task-specific balance training, participants will be secured in a safety harness 

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attached to an overhead I-bar out of precaution to prevent the hands and knees 
from contacting the floor should they lose their balance. Additionally, at least one 
research member will be present in close proximity to the participant during 
training to provide assistance if needed. However, we expect that most if not all 
of the exercises can be performed independently. Each session of task-specific 
balance training will last approximately 1 hour. At least one day of rest will be 
required in between weekly training sessions. 
Training Progression: The rate and magnitude of progression of task-
specific balance training will be determined bi-weekly via the Mini Balance 
Evaluation System Test (Mini-BESTest), which will be completed at the baseline 
session to determine baseline performance and repeated biweekly. If a 
participant demonstrates ≥5% (≥1 point) improvement, the exercises will be 
progressed by dosage (repetitions) and difficulty (complexity, intensity). These 
progression criteria align with the established MCID for the mini-BESTest (4 
points)36. 
 
Treadmill Perturbation-Based Training (Group B): Participants in Group B will 
complete reactive balance training consisting of repeated exposure to slip-like 
and trip-like perturbations delivered via ActiveStep treadmill (Simbex). Each 
session will begin with 10 minutes of warm-up/stretching exercises to prevent 
injury and strengthen postural muscles. During treadmill perturbation-based 
training, participants will be secured in a safety harness attached to an overhead 
I-bar out of precaution to prevent the hands and knees from contacting the floor 
should they lose their balance. Additionally, at least one research member will be 
present in close proximity to the participant during training to provide assistance 
if needed. Participants will be instructed about the possible occurrence of a slip 
or trip without being informed about their timing or nature. Participants will first 
receive a familiarization perturbation while walking in both the forward (slip-like) 
and backward (trip-like) directions, to minimize fear and the startle response. 
During each trial (unperturbed/perturbed, 10 seconds long), the treadmill belt will 
first ramp up to match the participants’ self-selected gait speed. For slip/trip trials, 
after 8-10 regular steps, the belt will accelerate in the forward (reverse) direction 
(for slips) or backward direction (for trips) causing a displacement of the base of 
support relative to the participant’s center of mass. Each participant will 
experience three levels (L1-L3) of perturbations (acceleration=6 m/s2; 
displacement=27-91 cm) over 16 sessions (24 slips and 24 trips per session) in a 
progressive, ascending way to increase the likelihood of successful adaptation. 
The protocol follows principles of motor learning to include block and random 
practice (wash-out walking trials) and overlearning (continued task practice after 
reaching a success criterion. Each session of treadmill perturbation-based 
training will last approximately 1 hour. At least one day of rest will be required in 
between weekly training sessions. 
Training Progression: On week 1, participants will start with lowest 
perturbation displacement level and move up to the next level by week 2 if they 
have < 5 falls out of 8 perturbations. By week 5, participants are expected to 
move to level 5 and train at that for weeks 5 to 8. If participants fail to move to the 
next level, they will continue on the lower level. This protocol has been previously 
piloted among healthy older adults, inducing adaptations in reactive balance and 
fall reductions 17,18. 
 

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Conventional Balance Training (Group C): Participants in Group C will 
complete progressive conventional balance training focused on stretching, 
strengthening, balance and proprioception, and endurance. Each session will 
begin with 10 minutes of warm-up/stretching exercises to prevent injury and 
strengthen postural muscles. During all exercises, participants will wear a gait 
belt out of precaution and at least one research member will be present in close 
proximity to the participant during training to provide assistance if needed. 
Strengthening will last for 20 min and include upper and lower limb exercises with 
dumbbells and therabands. Balance and proprioception exercises (20 min) are 
comprised of sit-to-stands, foam or rocker bottom standing, and sideways 
walking. Exercises will be followed by treadmill walking for 10 minutes (for 
endurance). Each session of conventional balance training will last approximately 
1 hour. At least one day of rest will be required in between weekly training 
sessions. 
Training Progression: The rate and magnitude of progression during 
conventional balance training will be determined biweekly by the timed-up and go 
test (TUG) and four-square step test (FSST), which are used to assess functional 
mobility and fall risk. During the TUG, participants are timed as they are asked to 
stand quickly from a chair, walk 3 meters, and sit back in the chair. During the 
FSST, participants are timed as they step forward, sideways, and backwards 
over low obstacles as quickly as they can. If a participant demonstrates ≥2 
second improvement on the TUG OR ≥1 second improvement on the FSST, then 
training will be progressed by dosage (repetitions) and difficulty (complexity, 
intensity). These progression criteria were selected based on the established 
MCIDs for the TUG (8 seconds) and FSST (4 seconds)37,38. 
 
Vital monitoring (All groups): During training for all groups, we will monitor 
heart rate and heart rate variability using a Polar ProTrainer 5 RS 800CX GPS 
monitor. Rated Perceived Exertion (Borg Scale) will be used to determine the 
exertion and fatigue level at least every 10 minutes, and we will also monitor 
blood pressure at least every 10 minutes during training.   
 
Workload: NASA TLX visual analog scale will be used to determine the 
perceived physical and mental load during training, about every 10 minutes. This 
score will be collected on an ipad/iphone and the data will be exported in the 
form of a .csv file. 
 
Session 18: Immediate Post-Training Assessment (All Groups) (2 hours) 
Within one week after completing their final session of training (session 17), all 
participants will return to the laboratory to complete a post-training assessment of their 
volitional and reactive balance control. The immediate post-training assessment will 
take about 2 hours. 
 
Volitional Balance Assessment: Immediately post-training, all groups will 
repeat the Functional Gait Assessment (FGA) (details of this test listed under 
session 1) to assess their volitional balance control. We will also assess 
participant’s balance confidence using the activities-specific balance confidence 
scale (ABC) (details of this test also listed under session 1).  
 

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Reactive Balance Assessment: Immediately post-training, all groups will 
complete an overground slip and trip test to assess their reactive balance control. 
 Prep-up: During the reactive balance assessment, participants will be set-
up with a body harness and reflective marker set. Electromyography 
(EMG) sensors will be placed on 8 locations (Tibialis Anterior, Medial 
Gastrocnemius, Quadriceps, and Hamstrings of both legs). This will 
measure the muscle responses to perturbations.  
 Overground Slip and Trip Test: Participants will be asked to walk on an 
overground walkway (mounted on force platforms). After at least three 
regular walking trials, an unannounced slip will randomly be induced under 
either limb (to increase unpredictability) by electro-mechanical release of a 
moveable low-friction platform (for slips, slides 90 cm), and an 
unannounced trip will be delivered by unexpected release of a horizontal 
plate into upright position (8 cm height). These trigger devices are 
camouflaged and embedded in the walking path39. The order of the slip 
and the trip will be randomized for each participant. Participants will be 
informed that a slip or trip may or may not occur on any trial, but will not 
be informed when/how the slip/trip will occur or on which side. All 
participants will wear a safety harness during the overground slip test 
which prevents their arms, knees, head, and trunk from contacting the 
ground should they experience a fall. 
 Vitals (heart rate, blood pressure, rating of perceived exertion – see 
details under training) and perceived workload (also see details under 
training) will also be collected at least every 5-8 trials during the reactive 
balance assessment. 
 
Session 19: Booster Training Session (All Groups) (1 hour) 
6 months after the completion of the final session of training (session 17), all groups will 
receive a single-session booster dose of their respective training (Group A: task-
specific balance training; Group B: treadmill perturbation-based training; Group C: 
conventional balance training). The booster dose will consist of one, 1 hour session 
which is a repeat of their final (16th) training session. Previous studies have indicated 
that the addition of a booster session can significantly aid in long-term retention and 
prevention of motor decay of fall-resisting skills, particularly in older adults 13,15. The 
booster training session is optional, and participants can opt-out of receiving the booster 
training session on the consent form if they wish. 
 
Session 20: 18-month Post-Training Assessment (All Groups) (2 hours) 
18-months post-completion of the final training session (session 17), all groups will 
return to the laboratory to reassess their volitional and reactive balance control. The 18-
month post-training assessment will consist of the same protocols/assessments as the 
immediate post-training session (refer to session 18 protocol), including the volitional 
balance assessment (FGA) and reactive balance assessment (overground slip and trip 
test). We will also re-assess participants’ balance confidence using the ABC. The 18-
month post-training assessment will take about 2 hours. The 18-month post-training 
assessment is optional, and participants can opt-out of returning to the lab for this 
session on the consent form if they wish. 
 

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18 Months Prospective falls tracking and ActiGraph monitoring (All Groups) 
Self-reported falls (All Groups): Per Prevention of Falls Network Europe (ProFane) 
recommendations40, falls will be recorded using prospective weekly recording via an 
electronic fall diary set up using REDCap (Research Electronic Data Capture) system. 
Participants will get a weekly text on their phone asking them if they had a fall or not in 
the past 7 days. A fall will be defined using lay terminology. The text will read “have you 
had any falls in the past 7 days including a slip or trip in which you lost your balance and 
landed on the ground or floor? If you wish to stop receiving these text messages, please 
reply STOP”. If participants respond “No”, the entry will be recorded in the REDCap 
database along with the date and time. If they respond “Yes”, they will receive a phone 
call within 72 hours from the research team to document fall circumstances via a 
survey. The fall survey includes questions about the circumstances surrounding a fall, 
including environmental factors, type of fall, perceived cause, and injury description. If 
participants reply STOP and wish to stop receiving text messages, we will stop sending 
them weekly texts and will follow up within 72 hours via phone call to inquire if they wish 
to continue participating in the study or change their method of contact.  
 
Participants who do not have a phone that can receive text messages can still be 
included in the study, and we will instead give them paper copies of fall logs for 
prospective falls tracking. Specifically, participants will be given paper copies of the fall 
logs and survey, with pre-stamped and pre-addressed envelopes to mail in to the lab 
monthly. If participants do not send the falls questionnaires back 2 consecutive times, 
we will call them to follow up. Even participants who have text messaging may also 
choose to use mail-in fall logs instead of texting if they prefer. Thus, participants will be 
given an option on the consent form to indiciate whether they wish to complete 
prospective falls monitoring via text message or via mail in logs.   
 
The 18 months prospective falls tracking is optional, and participants may opt-out of 
receiving both text messages and mail-in fall logs on the consent form if they wish. 
 
ActiGraph Monitoring (All Groups): The ActiGraph sensor allows prospective (18 
months) physical activity data (# of steps, gait speed, and distance) and fall data 
collection.  For participants who opt-in to wear the ActiGraph for 18-month monitoring, 
self-fall recording will be supplemented with ActiGraph. We will provide the ActiGraph 
again to participants on their last training session (session 17) along with the reminder 
about how to wear the sensor and charge it41-46.  For those who opt-in to upload their 
own data from the ActiGraph at home, we will provide them with an additional 
educational session about how to sync data to the cloud-based system. The research 
personnel will download the centerpoint mobile application on the participant’s phone 
(for participants with smartphones) and help them create a profile with the required 
personal information. The ActiGraph watch will be connected to their phone via 
Bluetooth. The participant will be asked to ensure that their Bluetooth is on for the real-
time data to sync to the cloud system. The website https://actigraphcorp.com/cpiw/ 
shows how the watch can be connected to the mobile phone. Participants who do not 
have a smartphone or request for us to upload their data for them will be requested to 

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visit the lab for data upload once every month. If they do not want to continue wearing 
the ActiGraph, they would be requested to return the watch to the research team.  
 
All Actigraph data will be uploaded to our secured server for further analysis. Consistent 
with best practices, telephone interviews (biweekly) will be used to rectify missing data 
and details regarding fall circumstances40,47.  A sooner phone follow-up will occur for 
non-compliant subjects (no response to the weekly fall question texts on >2 weeks).  
 
The ActiGraph company will have access to the raw data generated by their wearable 
sensor (e.g., number of steps, wear time, sleep time) while the study is active. This data 
will not contain any identifying information, as we will keep track of participants using 
only their subject number in the Centerpoint mobile application. After the study is closed 
in ActiGraph, the data will be moved to their archives, where it will no longer be 
accessible.    
 
Wearing the ActiGraph sensor for 18-months is optional, and participants may opt-out of 
wearing the ActiGraph sensor on the consent form if they wish. 
 
Compensation 
Participants will be compensated at the end of every study visit in cash in a pro-rated 
amount, even if they do not complete the entire study. For the initial screening and 
baseline clinical assessment, all groups (A,B,C) will receive $30. Participants will 
receive this compensation even if they are not eligible for the study after the initial 
screening. During training, participants will receive $10 per training session, for a total of 
$160 if they complete all 16 training sessions. Participants will also receive $10 for 
completing the booster training session. Participants will receive $20 each for the 
immediate 
post-training 
assessment 
and 
18-month 
post-training 
assessment. 
Participants in all groups will also have the opportunity to upload their physical activity 
data (obtained via Actigraph) for $10 per monthly upload, up to 18 months of uploads 
($180 total). Participants will receive the compensation for monthly physical activity 
uploads when they come to the lab for their booster training dosage (after 6 months) 
and for their 18-month post training assessment. All groups will have the possibility of 
receiving up to $420 if they complete all aspects of the study. A summary of study 
compensation is provided in the table below. 
 
 
Session Type 
Frequency 
Compensation 
Total 
Initial Screening & Baseline 
Assessment 
1 
$30 
$30 
Training 
16 
$10 
$160 
Immediate Post-Training Assessment 
1 
$20 
$20 
Booster Training Dose 
1 
$10 
$10 
18-month Post-Training Assessment 
1 
$20 
$20 
Physical Activity Data Uploads 
18 
$10 
$180 
Total Compensation Possible = $420  

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Outcome Measures 
The primary outcomes for Aim 1 will be laboratory falls, reactive stability, and 
limb support on the overground slip and trip test. Laboratory falls induced on 
overground slips and trips will be quantified from the load cell data and verified by video 
recording48. Falls will be identified if the peak loadcell force is ≥ 30% of body weight48; 
otherwise, the trial will be classified as a recovery48. Reactive stability: Reactive stability 
at post-perturbation recovery foot touchdown will be computed as the shortest distance 
of the COM state (relative BOS) to the extensively validated computational thresholds of 
stability limits for backward (slips) and forward balance loss (trips)39,49-53. Values < 0 
(slips) or > 1.2 (trips) indicate instability and between 0 and 1.2 indicate greater stability 
against both slips and trips 54. Limb Support: Limb support will be quantified by hip 
height  (Zhip) obtained as the vertical distance of the bilateral hip midpoint to the surface 
of the platform, and then normalized to body height 25,55,56. Minimum hip height and its 
change from pre- to post-perturbation will be extracted. We will compare differences in 
Aim 1 outcomes between Groups A, B, and C immediately post-training (to examine 
immediate improvements) and 18-months post-training (to examine 18-month 
retention).  
 
The primary outcome for Aim 2 will be the functional gait assessment (FGA). We 
will compare performance on the FGA between Groups A, B, and C immediately post-
training (to examine immediate improvements) and 18-months post-training (to examine 
18-month retention). We will also examine within-group improvements by comparing 
performance pre- and post-training. 
 
The primary outcome for Aim 3 will be the 18-month retention of outcomes from Aim 
1 (laboratory falls, reactive stability, limb support) and Aim 2 (FGA) and real-life falls. 
The secondary outcome for Aim 3 will be balance confidence via the Activities-Specific 
Balance Confidence Scale (ABC). We will compare rates of real life falls between 
Groups A, B, and C over 18 months post-training, and compare immediate and retained 
improvements in ABC scores. 
 
Aim 4 will be an exploratory aim to determine if task-specific training results in 
neuromuscular adaptation that produces optimal muscle synergies during both 
unperturbed and perturbed walking for fall prevention. Using data from Dr. Bhatt’s 
previous clinical trial (R01AG050672), we will select overground slip trials in which older 
adults demonstrate successful adaptation to overground perturbation training, and 
examine if task specific training can produce similar synergies post-training. The 
primary outcome for Aim 4 will be the correlation (r value) between reconstructed 
optimal muscle synergies and the post-training experimental muscle synergies 
from Groups A-C. 
 
7.0 
Expected Risks/Benefits 
Potential Risks: 
Overground Slip and Trip Tests (All Groups), Treadmill Slips and Trips (Group B – 
Treadmill Perturbation-based Training): During the overground and the treadmill 
perturbations, there is a slight risk of falls and injury (e.g., a muscle pull at shoulder, leg, 

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or back). To prevent falls, all the participants will wear a full-body protected harness to 
prevent any part of the body other than the feet contacting the ground. The harness has 
adjustable shoulder and leg straps, and will be attached to an overhead trolley that will 
allow the participants to perform movements freely having neither the knees nor hands 
touching the treadmill belt/force platform. During the past several years, in more than 
500 experimental sessions for both young and older adults conducted by the research 
team, similar harness systems have successfully protected subjects from injury 
following induced slips and trips during standing or walking tasks. The harness system 
incorporates a number of safety features designed to limit the peak forces applied to the 
body, thereby minimizing the risk of injury upon a fall into the harness. The full-body 
harness is padded and provides support over a large contact area (>1500 cm2), 
primarily in regions that are able to withstand larger forces without injury (i.e. the pelvis 
and buttocks).  Shoulder suspension of the harness provides protection against both 
forward and backward falls, with negligible risk of straps entanglement. Finally, the 
extent of body descent before harness assistance begins is limited (15 cm on average) 
and very carefully calibrated and controlled. Our calculations indicate that, during a 
worst-case fall into the harness, an individual who weighs 1000 N would be subjected to 
a peak pressure of < 0.3 MPa, well below the stress threshold for even a moderate 
muscle contusion (1.9 MPa), requiring no medical treatment. Participants in Group A will 
also wear the safety harness during task-specific training out of caution, even though 
most exercises can be performed independently. 
 
Training sessions (All Groups): The initial training sessions may cause some muscle 
soreness and discomfort in the lower limbs which may result in increased pain during 
the first week of training, which will then be settled once the training sessions progress. 
 
Preventing injury during slip and trip tests/treadmill-perturbation training: All participants 
will undergo a series of stretching and warm-up exercises at the start of the sessions. A 
physical therapist or an exercise specialist on the team will conduct these procedures. 
Stretches will encompass all major muscle groups of the lower limbs and trunk.  Warm-
ups include activities such as walking, lunges, squats, high stepping and chair rise. To 
protect the safety of all participants during the overground and treadmill slips and trips, 
all participants will wear a full-body safety harness at all times to prevent their arms or 
knees from contacting the ground should they experience a fall. There will also be at 
least one research assistant standing by the participant during all slip and trip trials to 
guard them and provide assistance should they experience a fall. Additionally, we will 
have participants wear a heart rate monitor which will constantly monitor their heart rate 
(Polar ProTrainer 5 RS 800CX GPS). If heart rate ever exceeds the normal limits (i.e., 
85% of age-predicted maximal heart rate), the session will immediately be terminated 
and the participant will be asked to sit down until their heart rate returns to normal limits. 
Additionally, we will use a blood pressure monitor to monitor blood pressure after every 
slip and trip trial, and after every 5-8 walking trials. If systolic blood pressure exceeds 20 
mmHg of the resting state or diastolic blood pressure exceeds 15 mmHg of the resting 
state, the session will immediately be terminated and the participant will be asked to sit 
down until their blood pressure returns to normal limits. We will also ask participants to 
provide their rating of perceived exertion on the Borg Scale after every slip and trip trial, 

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and after every 5-8 walking trials. If participants feel extremely tired (i.e., >15 on the 
Borg Scale), it would indicate that the intensity of the physical activity was high and the 
participant would need to sit down and rest. Additionally, participants will be asked to 
inform the experimenter about any symptoms including marked breathlessness, 
excessive sweating, pain in chest, or fatigue.  The research personnel will observe for 
any changes in participant’s facial expression indicating anxiety or discomfort.  In case 
of any discomfort, the session will be terminated, and the time of the training session 
will be noted. All participants will additionally receive a rest break after 30 minutes and 
given a chair to sit down in. Additionally, participants will be called 2 days after their 
testing sessions to determine if there were any symptoms or discomfort due to the 
testing session. At this time, they would be asked to confirm that no outside injury/ 
accident/falls have taken place in the event they report any pain or soft tissue injury/ 
sprain/strain. These precautionary features have evolved through a decade of research 
to prevent falls and injuries.   
 
All participants, regardless of group, will follow the same safety procedures during the 
slip and trip tests. These safety procedures are designed to provide the highest level of 
safety to all participants, regardless of their group classification and prior training. 
 
Preventing injury during testing and training sessions: Blood pressure and heart rate will 
be monitored prior to and throughout the testing and training sessions. Participants will 
be given a chair to sit back after approximately 30 minutes or if he/she feels tired (i.e., ≥ 
15 on Borg scale for perceived exertion) or if the blood pressure is beyond normal limits 
(i.e. > 85% of age-predicted maximal heart rate). More than or equal to 15 on the Borg 
scale of perceived exertion indicates that the intensity of the physical activity performed 
was high and that it gives an idea to the research personnel that the participant would 
need to slow his movements down.  Additionally, if at any point the heart rate or blood 
pressure drops or rises above the pre-determined acceptable limits, the session will be 
terminated. Participants will be asked to inform the experimenter about any of the 
symptoms including marked breathlessness, excessive sweating, pain in chest, or 
fatigue. The research personnel will observe for any changes in participant’s facial 
expression indicating anxiety or discomfort. In case of any discomfort, the session will 
be terminated, and the time of the training session will be noted. The proposed setup 
incorporates several precautionary features, evolved through a decade of research, 
against such injuries. To further reduce the risk of injury, all subjects will undergo a 
series of stretching and warm-up exercises at the start of the experiment and training.  
A physical therapist or an exercise specialist on the team will conduct these procedures.  
Stretches will encompass all major muscle groups of the lower limbs and trunk.  Warm-
ups include activities such as walking, lunges, squats, high stepping and chair rise.   
 
Abnormal Findings: There is a possibility that we will find significant cognitive decline, 
high blood pressure, or osteoporosis in participants. If we observe any clinically 
significant findings regarding cognitive decline, blood pressure, or osteoporosis (or any 
other life-threatening findings), we will immediately inform participants, provide them 
with a copy of their cognitive scores/blood pressure/osteoporosis screening, and advise 
them to follow up with their physician to have appropriate medical evaluation. If any of 

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these was cause for exclusion, we will inform them and discuss why they have been 
excluded from the study. The measures in this study will only be considered for 
research purposes and are not used for treating or diagnosing any medical condition. 
 
Emergency Contact/Physician Information: While signing the consent form, participants 
will have the opportunity to provide the contact information for their emergency contact 
or primary physician, and can opt in or out of us contacting their emergency contact or 
physician in the case of an unexpected event or emergency. We will not directly share 
the scores of clinical tests (cognitive, blood pressure, osteoporosis) with the 
participant’s emergency contact or physician unless directly relevant in the emergency 
situation. However, participants will be encouraged to share their test scores with their 
physician if anything abnormal is noticed by the research team. 
 
 
Potential Benefits: 
We expect no direct benefits from participating in this study. If participants demonstrate 
no gains, the testing and intervention sessions offered will maintain their optimal 
physical functioning and not result in any deterioration. 
 
8.0 
Data Collection and Management Procedures 
The overall goals of data management are to ensure: 1) that the collected data is 
properly documented and accurately entered; 2) the confidentiality of the subject 
data is maintained giving access to the primary investigators for retrieving data 
and exporting to statistical packages. Prior to data collection and entry, a 
codebook will be created which will contain the variable names, descriptions, and 
value codes of each variable/item collected during the study. Following 
development of the codebook, a database will be created in Microsoft Excel to 
facilitate data entry. The program permits logic checks on input and checks for 
invalid entries. One research staff member will enter all data separately, and 
another researcher will verify the data entry to identify any mismatching data 
values, variable names, or observation numbers thus, to eliminate data entry 
errors. Several data quality checks will also be conducted, including descriptive 
statistics and graphic plots to detect outliers and influential observations. All 
computer data will be stored in a password-protected network server with back-
up scheduled every midnight. The network server is managed by UIC Applied 
Health Sciences (\\uicfs.server.uic.edu\AHS-PT1 or AHS-PT2). Data coding keys 
will be stored in a separate file from the data. The original raw data will be stored 
in a locked cabinet accessed only by key project personnel. Only the Principal 
Investigator and one research team member have the access key, and there are 
no duplicate keys. The motion analysis data will also be backed up on a portable 
hard drive and stored in a locked cabinet accessed only by key project 
personnel. 
 
Each laboratory session will be recorded with a video camera system for further 
analysis of body responses. The 3D motion cameras will detect small ball-
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ankles, knees, hips, shoulders, elbows, and wrists to represent body movement.   
Only the investigators related to this project will have access to these files. The 
videotape or its reproduction may be used for research purposes such as 
publication in scientific journals or presentations at educational or scientific 
meetings and teaching purposes in the future.  All of the videos are taken from 
the side and back, where no facial feature will be identifiable. Thus, the 
participant would not be recognizable by a stranger without other identification 
from the record.  
 
All the files will be destroyed along with the videotape of the experiment 2 years 
after completion of the entire project, at which point all data will become de-
identified.  
 
Adverse Event and Serious Adverse Event Collection and Reporting 
An adverse event is defined as an undesirable and unintended result of therapy, 
intervention or interaction experienced by a subject participating in a research 
study.  We will monitor adverse events, reported by participants during the 
intervention and maintenance phases of the study and as reasons for drop out.  
All field staff who work directly with participants will be required to notify the PIs 
of any unanticipated problems/adverse events immediately upon discovery.  If an 
adverse event is recorded during the intervention session the session will be 
concluded and the event reported to their physician and to the investigators.   
Participants who report the event will notify the University IRB. The PIs will 
immediately notify the appointed Safety Officer (Radhika Sreedhar, MD, MS) and 
the University Institutional Review Board.  
The relationship of the adverse event as not related, possibly related or definitely 
related will be determined using standard criteria for clinical trials and any 
additional guidelines used/ developed by the Safety Officer and the University 
Institutional Review Board.  
Possible - to qualify, the adverse event must meet 2 of the following conditions:  
1) Has a reasonable temporal relationship to the intervention,  
2) Could not readily have been produced by the subject's clinical state,  
3) Could not readily have been due to environmental or other interventions,  
4) Follows a known pattern of response to intervention,  
5) Disappears or decreases with reduction in cessation of intervention.  
 
Probable - to qualify, the adverse event must meet 3 of the following conditions:  
1) Has a reasonable temporal relationship to the intervention,  
2) Could not readily have been produced by the subject's clinical state,  
3) Could not readily have been due to environmental or other interventions,  
4) Follows a known pattern of response to intervention 
5) Disappears or decreases with reduction in cessation of intervention.  
 

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Definite - to qualify, the adverse event must meet at least 4 of the following 
conditions:  
1) Has a reasonable temporal relationship to the intervention,  
2) Could not readily have been produced by the subject's clinical state,  
3) Could not readily have been due to environmental or other interventions,  
4) Follows a known pattern of response to intervention,  
5) Disappears or decreases with reduction in cessation of intervention 
 
9.0 
Data Analysis 
All the data analysis will be performed at 1919 W Taylor St. Room 415 or B-56 using the 
SPSS Inc. (Armonk, NY).  Also, see the section “Statistical Considerations”. 
 
10.0 Quality Control and Quality Assurance 
 
For quality control and assurance, all the study related procedures will be 
performed by trained and experienced personnel. All research personnel will take 
the CITI and HIPAA training courses along with regular training to ensure safety 
of the custom designed equipment. The raw data will be checked by the PI 
immediately after data collection. 
 
11.0 Data and Safety Monitoring 
 
There will be a data and safety monitoring plan in place monitored by the 
research team itself, as well as monitoring by the appointed safety officer 
(Radhika Sreedhar, MD, MS). 
 
Monitoring by research team:  
The goals of data management are: (a) to ensure that data collected during the 
study are properly and accurately entered and documented; (b) to ensure that 
data will be stored in an electronic format that will allow the primary investigators 
of the project to retrieve data easily and to export data to statistical packages; 
and (c) to ensure the confidentiality of subjects. (See details under Data 
Collection and Management Procedures).  
For monitoring subject safety during the assessment and training sessions: 
Subjects will be asked whether they are feeling any pain or any kind of 
distress at regular intervals.  Subjects’ heart rate and blood pressure will be 
monitored every 5-8 trials, immediately after slip or trip exposure, and/or after 
~10 minutes. The experiment will be stopped if HR >85% of age predicted 
maximum, systolic BP exceeds > 20 mmHg of the resting state, or if the 
diastolic BP exceeds > 15 mmHg from the resting state.  There will always be 
two people in the experiment area to assist the subject if required. There is 
always a first aid kit available in the lab for use in case of any minor injury.  
We also have an AED for emergencies and at least one of the investigators 
during any experiment will be AHA-BLS (American Heart Association - Basic 

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Life Support) certified for health care providers.  In addition, we do regular 
harness checks to ensure that it is not damaged. Also, the subjects will be 
called 2 days after each of their test sessions to determine if there were any 
symptoms or discomfort due to the test session. 
 
Monitoring by the Safety Officer:  
The appointed Safety Officer (Radhika Sreedhar, MD, MS) will monitor the 
implementation of the research protocol to ensure protection of subjects and 
data. The Safety Officer will meet with the PI quarterly to discuss issues related 
to recruitment, data collection and quality, and compliance of intervention(s). The 
Safety Officer will provide guidance and oversee study activities.  
The Safety Officer will:  
 Monitor the progress of trial and the safety of subjects 
 Monitor and provide guidance for assuring data accuracy and protocol 
compliance 
 Report unanticipated problems involving risks to subjects or others as well 
as adverse events, to the IRB, and NIH, if applicable 
 Review on a regular basis the accumulated research data from the 
ongoing study 
 Advise the sponsor and the PI regarding the continuing safety of study 
subjects and those yet to be recruited into the research trial  
 Advise the sponsor and the PI as to the continuing validity and scientific 
merit of the trial.  
 
12.0 Statistical Considerations 
A between-groups analysis of covariance (ANCOVA), controlling for likely 
covariates and risk factors as well as demographic variables that are found 
imbalanced among the experimental groups in spite of randomization, will 
compare the difference in stability and limb support (on overground slip and trip 
tests) amongst Groups A, B & C. For laboratory falls, we will treat the fall 
outcome as a binary variable (fall: 1 and no-fall: 0). We will use chi-square test 
and multivariable logistic regression to compare slip and trip-specific falls, and 
total falls amongst Groups A, B & C. We will utilize Mixed-effects ANCOVA to 
assess the training effects on the FGA among Groups A, B, and C. The mixed-
effects model is a combination of a between-groups ANCOVA (Groups A, B & C) 
and a within-groups ANCOVA (pre- and post-training). Mixed-effects ANCOVA 
model (for stability, limb support and FGA) and the generalized estimating 
equation (GEE) model (for lab falls incidence) accounting for within-subject 
covariance across time will be used to detect the retention effect 18 months after 
initial training. For real-life falls (which is not a repeated outcome), we will employ 
simple Chi-square test and multivariable logistic regression (if covariates control 
is needed) to determine if such training effect can be translated into everyday 
real-life setting. We will treat real-life falls during the 18 months as a binary 
outcome (yes or no). Pearson correlation coefficients (r) will be calculated to 

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analyze the similarities between optimal synergies and post-training synergies 
recruited in Groups A, B & C. Specifically, we will compare both the spatial 
structure and the time-varying temporal component of the muscle synergies 
between the optimal muscle synergies and experimental muscle synergies for 
each group. 
 
13.0 Regulatory Requirements 
13.1 Informed Consent  
Participants will be invited to the laboratory on passing the phone screening.    
Those who are eligible and elect to participate will be provided with a written 
informed consent document (approved by the University of Illinois at Chicago 
IRB). Consent will then be obtained by trained research coordinators. The 
informed consent document and telephone screening document will be stored in 
a cabinet under lock and key located in AHS B-56, as they contain identifiable 
subject information. This locked cabinet will not contain any other data collection 
forms which have been collected using the subjects assigned alphanumerical 
code, to protect subject confidentiality and avoid linking the coded data to the 
identifiable information. Only the PI (Dr. Tanvi Bhatt) and one research team 
member will keep the key to this locked cabinet, and only active members of the 
research team will be able to access the completed informed consent forms and 
telephone screening forms upon PI approval.All study participant documents will 
be available in English. The consent form will explain all procedures, risks, and 
benefits of the study. The study subject will communicate their intention to leave 
the study clearly to any study staff personnel, and their confidentiality will not be 
breached. Subjects will receive a signed copy of the informed consent document 
upon request. 
13.2 Subject Confidentiality  
Subjects’ confidentiality would be maintained as all data will be collected and 
stored using a subject specific, unique alpha-numeric code that is assigned at the 
time of enrollment. All study records will be kept confidential by using this 
numerical code. A participant will not be identified personally in any report of the 
results. We will keep the identifying information (screening documents, consent 
form) at a centralized single location which will be locked and it will be destroyed 
2 years after the completion of the entire project, at which point all data will 
become deidentified. Only key research personnel of the research team will have 
access to the raw data. This research doesn’t involve the use and disclosure of 
protected health information. Participants would be consented regarding usage of 
their videotapes in conference or for educational purposes.  
 
We will also keep the screening documents for participants who have failed the 
screening and were not included in the study, in order to maintain accurate 
records of how many potential participants were excluded from the study, and for 
what reasons. These documents will be kept in the same locked cabinet as the 

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identifiable information for included participants (as mentioned above), and 
separated from any and all coded data, to protect subject confidentiality.  
13.3 Unanticipated Problems 
Any unanticipated problems will be reported to the IRB by submitting a “Prompt 
Report” form.  

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14.0 References 
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Practice & Research Clinical Rheumatology. 2005;19(6):913-935.  
3. 
Duthie Jr EH. Falls. The Medical clinics of North America. 1989;73(6):1321-1336.  
4. 
Karlsson MK, Magnusson H, von Schewelov T, Rosengren BE. Prevention of 
falls in the elderly—a review. Osteoporosis international. 2013;24:747-762.  
5. 
Masud T, Morris RO. Epidemiology of falls. Age and ageing. 2001;30(suppl_4):3-
7.  
6. 
Cuevas-Trisan R. Balance problems and fall risks in the elderly. Clinics in 
geriatric medicine. 2019;35(2):173-183.  
7. 
Boyé ND, Van Lieshout EM, Van Beeck EF, Hartholt KA, Van der Cammen TJ, 
Patka P. The impact of falls in the elderly. Trauma. 2013;15(1):29-35.  
8. 
Davis JC, Robertson MC, Ashe MC, Liu-Ambrose T, Khan KM, Marra CA. 
International comparison of cost of falls in older adults living in the community: a 
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9. 
Jones S, Blake S, Hamblin R, Petagna C, Shuker C, Merry A. Reducing harm 
from falls. 2016; 
10. 
Burns E. Deaths from falls among persons aged≥ 65 years—United States, 
2007–2016. MMWR Morbidity and mortality weekly report. 2018;67 
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risk associated with a fall according to type of fall among the elderly. Osteoporosis 
International. 2000;11:631-634.  
12. 
Bhatt T, Pai Y. Generalization of gait adaptation for fall prevention: from 
moveable platform to slippery floor. Journal of Neurophysiology. 2009;101(2):948-957.  
13. 
Bhatt T, Pai Y-C. Prevention of slip-related backward balance loss: the effect of 
session intensity and frequency on long-term retention. Archives of physical medicine 
and rehabilitation. 2009;90(1):34-42.  
14. 
Bhatt T, Wening J, Pai Y-C. Influence of gait speed on stability: recovery from 
anterior slips and compensatory stepping. Gait & posture. 2005;21(2):146-156.  
15. 
Bhatt T, Yang F, Pai Y-C. Learning to resist gait-slip falls: long-term retention in 
community-dwelling older adults. Archives of physical medicine and rehabilitation. 
2012;93(4):557-564.  
16. 
Pai Y-C, Bhatt T, Yang F, Wang E, Kritchevsky S. Perturbation training can 
reduce community-dwelling older adults’ annual fall risk: a randomized controlled trial. 
Journals of Gerontology Series A: Biomedical Sciences and Medical Sciences. 
2014;69(12):1586-1594.  
17. 
Lee A, Bhatt T, Liu X, Wang Y, Wang S, Pai Y-CC. Can treadmill slip-
perturbation training reduce longer-term fall risk upon overground slip exposure? 
Journal of applied biomechanics. 2020;36(5):298-306.  
18. 
Wang Y, Bhatt T, Liu X, et al. Can treadmill-slip perturbation training reduce 
immediate risk of over-ground-slip induced fall among community-dwelling older adults? 
Journal of biomechanics. 2019;84:58-66.  
19. 
Cuevas-Trisan R. Balance Problems and Fall Risks in the Elderly. Clin Geriatr 
Med. May 2019;35(2):173-183. doi:10.1016/j.cger.2019.01.008 

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20. 
Oliveira MRd, Inokuti TT, Bispo NNdC, Oliveira DAdAP, Oliveira RFd, Silva Jr 
RAd. Elderly individuals with increased risk of falls show postural balance impairment. 
Fisioterapia em Movimento. 2015;28:269-276.  
21. 
Sairafian K, Towe CW, Crandall M, Brown LR, Haut ER, Ho VP. 
Sociodemographic patterns of outpatient falls: do minority patients fall less frequently? 
Journal of surgical research. 2019;243:332-339.  
22. 
Tromp A, Pluijm S, Smit J, Deeg D, Bouter L, Lips P. Fall-risk screening test: a 
prospective study on predictors for falls in community-dwelling elderly. Journal of clinical 
epidemiology. 2001;54(8):837-844.  
23. 
Bhatt T, Wening J, Pai Y-C. Adaptive control of gait stability in reducing slip-
related backward loss of balance. Experimental Brain Research. 2006;170:61-73.  
24. 
Pai Y-C, Bhatt T, Wang E, Espy D, Pavol MJ. Inoculation against falls: rapid 
adaptation by young and older adults to slips during daily activities. Archives of physical 
medicine and rehabilitation. 2010;91(3):452-459.  
25. 
Yang F, Bhatt T, Pai Y-C. Role of stability and limb-support control against fall 
following a novel slip induced in different tasks. Journal of Biomechanics. 
2009;42(12):1903-1908.  
26. 
Bhatt T, Wang Y, Wang S, Kannan L. Perturbation Training for Fall-Risk 
Reduction in Healthy Older Adults: Interference and Generalization to Opposing Novel 
Perturbations Post Intervention. Front Sports Act Living. 2021;3:697169. 
doi:10.3389/fspor.2021.697169 
27. 
Devasahayam AJ, Farwell K, Lim B, et al. The effect of reactive balance training 
on falls in daily life: an updated systematic review and meta-analysis. medRxiv. 
2022:2022.01.27.22269969. doi:10.1101/2022.01.27.22269969 
28. 
Wang S, Varas-Diaz G, Dusane S, Wang Y, Bhatt T. Slip-induced fall-risk 
assessment based on regular gait pattern in older adults. Journal of biomechanics. 
2019;96:109334.  
29. 
Wang S, Pai Y-CC, Bhatt T. Gait Slip-Induced Fall-Type Assessment Based on 
Regular Gait Characteristics in Older Adults. Journal of Applied Biomechanics. 
2022;38(3):148-154.  
30. 
Liu-Ambrose TY, Ashe MC, Graf P, Beattie BL, Khan KM. Increased risk of falling 
in older community-dwelling women with mild cognitive impairment. Physical therapy. 
Dec 2008;88(12):1482-91. doi:10.2522/ptj.20080117 
31. 
Thompson PW, Taylor J, Oliver R, Fisher A. Quantitative ultrasound (QUS) of the 
heel predicts wrist ad osteoporosis-related fractures in women aged 45-75 years. 
Journal of Clinical Densitometry. 1998;1:219-225.  
32. 
Pai Y-C, Yang F, Bhatt T, Wang E. Learning from laboratory-induced falling: 
long-term motor retention among older adults. Age. 2014;36:1367-1376.  
33. 
Forouzandeh F, Aziz Ahari A, Abolhasani F, Larijani B. Comparison of different 
screening tests for detecting diabetic foot neuropathy. Acta Neurologica Scandinavica. 
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34. 
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35. 
Carpenter M, Carpenter R, Peel J, Zukley L. The reliability of isokinetic and 
isometric leg strength measures among individuals with symptoms of mild osteoarthritis. 
Journal of sports medicine and physical fitness. 2006;46(4):585.  
36. 
Anson E, Thompson E, Ma L, Jeka J. Reliability and fall risk detection for the 
BESTest and Mini-BESTest in older adults. Journal of geriatric physical therapy (2001). 
2019;42(2):81.  
37. 
Batting M, Hannink E, Barker K. Minimal clinically important difference of the 
Four Square Step Test in people with degenerative spinal conditions. Physiotherapy. 
2022;115:58-60.  
38. 
Brooks D, Davis AM, Naglie G. Validity of 3 physical performance measures in 
inpatient geriatric rehabilitation. Archives of physical medicine and rehabilitation. 
2006;87(1):105-110.  
39. 
Bhatt T, Wening JD, Pai Y-C. Influence of gait speed on stability: Recovery from 
anterior slips and compensatory stepping. Gait and Posture. 2005;21:146-156.  
40. 
Lamb SE, Jørstad‐Stein EC, Hauer K, Becker C, Europe PoFN, Group OC. 
Development of a common outcome data set for fall injury prevention trials: the 
Prevention of Falls Network Europe consensus. Journal of the American Geriatrics 
Society. 2005;53(9):1618-1622.  
41. 
Sposaro F, Danielson J, Tyson G. iWander: An Android application for dementia 
patients. IEEE; 2010:3875-3878. 
42. 
Sposaro F, Tyson G. iFall: an Android application for fall monitoring and 
response. IEEE; 2009:6119-6122. 
43. 
Chen J, Kwong K, Chang D, Luk J, Bajcsy R. Wearable sensors for reliable fall 
detection. IEEE; 2006:3551-3554. 
44. 
Gjoreski H, Lustrek M, Gams M. Accelerometer placement for posture 
recognition and fall detection. IEEE; 2011:47-54. 
45. 
Kangas M, Konttila A, Lindgren P, Winblad I, Jämsä T. Comparison of low-
complexity fall detection algorithms for body attached accelerometers. Gait & posture. 
2008;28(2):285-291.  
46. 
Tong L, Chen W, Song Q, Ge Y. A research on automatic human fall detection 
method based on wearable inertial force information acquisition system. IEEE; 
2009:949-953. 
47. 
Hufford M, Stone A, Shiffman S, Schwartz J, Broderick J. Paper vs. electronic 
diaries: compliance and subject evaluations. 2002. Applied Clinical Trials. 2017:38-43.  
48. 
Yang F, Pai Y-C. Automatic recognition of falls in gait-slip training: Harness load 
cell based criteria. . Journal of Biomechanics. 2011;44(12):2243-2249.  
49. 
Yang F, Anderson FC, Pai Y-C. Predicted threshold against backward balance 
loss following a slip in gait. Journal of biomechanics. 2008;41:1823-1831.  
50. 
Barbeau H. Locomotor training in neurorehabilitation: emerging rehabilitation 
concepts. Neurorehabilitation & Neural Repair. 2003;17(1):3-11.  
51. 
Bhatt T, Pai CY-C. Immediate & longer-term inter-limb transfer of adaptive gait 
stability improvements following repeated exposure to slips. Program No 34913 2006 
Neuroscience Meeting Planner Atlanta, GA: Society for Neuroscience, 2006 Online. 
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53. 
Bhatt T, Wening JD, Pai Y-C. Adaptive control of gait stability in reducing slip-
related backward loss of balance. Experimental Brain Research. 2006;170(1):61-73.  
54. 
Wang S, Bhatt T. Kinematic Measures for Recovery Strategy Identification 
following an Obstacle-Induced Trip in Gait. Journal of Motor Behavior. 2022:1-9.  
55. 
Pavol MJ, Runtz EF, Pai Y-C. Diminished stepping responses lead to a fall 
following a novel slip induced during a sit-to-stand. Gait & Posture. 2004;20(2):154-162.  
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APPENDICES 
Trial Record Sheet 
Subject ID: 
 
Subject Number: 
Date:  
Trial
Type 
Notes 
1 
 
 
2 
 
 
3 
 
 
4 
 
 
5 
 
 
6 
 
 
7 
 
 
8 
 
 
9 
 
 
10 
 
 
11 
 
 
12 
 
 
13 
 
 
14 
 
 
15 
 
 
16 
 
 
 
17 
 
 
 
18 
 
 
 
19 
 
 
 
20 
 
 
 
21 
 
 
22 
 
 
23 
 
 
24 
 
 
25 
 
 
26 
 
 
27 
 
 
28 
 
 
29 
 
 
30 
 
 
31 
 
 
32 
 
 
33 
 
 
34 
 
 
35 
 
 
36 
 
 
37 
 
 
38 
 
 

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Demographics 
 
1. Sex: 
        M 
 F 
 
2. Weight:   
 
 
3. Height:   
 
 
4. Dominant leg: 
   Dominant hand:   
 
 
5. ASIS Width:   
 
 
6. Knee width (largest girth):   
 
 
7. Ankle width (malleolus to malleolus):   
 
 
8. Sacrum marker to L3/L4 Length:   
 
9. BP: ______________ 
10. HR: ______________