"Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?"
Phase: NA
Conditions: Dizziness
Sponsor: AdventHealth

 
 
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Prospective Research Study Protocol Template 
 
Study Protocol Title: 
“Can A Prescribed Walking Program with or without Monitoring Impact Dizziness in the Older 
Adults?” 
 
Study Sponsor:   
Florida Hospital 
 
Principal Investigator: 
Amie Marie Jasper 
 
 

 
 
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List of Abbreviations: ..................................................................................................................... 4 
Introduction ..................................................................................................................................... 5 
Background Information and Scientific Rationale ......................................................................... 5 
Study Objectives ............................................................................................................................. 8 
Study Design ................................................................................................................................... 8 
Research Design .......................................................................................................................... 8 
Study Agent, Device, and/or Intervention Description ............................................................... 9 
Study Site(s)/Location(s) and Number of Subjects .................................................................... 9 
Multi-Site Research Logistics/Communication Plan .................................................................. 9 
Research Conducted in a Foreign Country ............................................................................... 10 
Community-Based Participatory Research ............................................................................... 10 
Subject Selection ........................................................................................................................... 10 
Vulnerable Populations (if applicable) ..................................................................................... 10 
Inclusion Criteria ...................................................................................................................... 10 
Exclusion Criteria ..................................................................................................................... 10 
Resources Available ...................................................................................................................... 10 
Study Procedures .......................................................................................................................... 12 
Subject Recruitment and Screening .......................................................................................... 12 
Consent Process ........................................................................................................................ 12 
Documentation of Informed Consent Process .......................................................................... 12 
Randomization .......................................................................................................................... 12 
Study Visits ............................................................................................................................... 14 
Study Duration .......................................................................................................................... 16 
Materials of Human Origin:  Collection, Preparation, Handling and Shipping ........................ 17 
Study Outcome Measures (Endpoints) ......................................................................................... 17 
Data Management and Quality Plan ............................................................................................. 18 
Data De-identification ............................................................................................................... 18 
Data Confidentiality, Storage, and Retention ........................................................................... 19 
Data Quality .............................................................................................................................. 19 
Data Sharing (outside of Florida Hospital) ............................................................................... 19 
Sample Size Determination ........................................................................................................... 19 
Statistical Analysis Plan ................................................................................................................ 20 
Potential Risks and Benefits ......................................................................................................... 21 

 
 
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Potential Benefits ...................................................................................................................... 21 
Potential Risks .......................................................................................................................... 21 
Mitigation of Risks ................................................................................................................... 21 
Provisions to Protect the Privacy Interest of Subjects .............................................................. 21 
Early Withdrawal of Subjects ....................................................................................................... 21 
Investigator Withdrawal of Subjects ......................................................................................... 21 
Subject Request for Withdrawal from Study ............................................................................ 21 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 22 
Adverse Event Reporting .............................................................................................................. 22 
Safety Monitoring Plan ................................................................................................................. 22 
Safety Monitoring N/A ............................................................................................................. 22 
Data and Safety Monitoring Board (DSMB) or Equivalent ..................................................... 22 
Ethical Considerations .................................................................................................................. 22 
Sharing of Results with Subjects .............................................................................................. 22 
Funding Source ............................................................................................................................. 22 
Subject Stipends or Payments ....................................................................................................... 22 
Publication Plan ............................................................................................................................ 23 
References ..................................................................................................................................... 23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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List of Abbreviations: 
 
ABC  
- Activities-Specific Balance Confidence 
DHI   
– Dizziness Handicap Inventory 
DGI   
– Dynamic Gait Index 
ICF 
 
- International Classification of Functioning, Disability and Health 
IPAQ   
– International Physical Activity Questionnaire 
mCTSIB 
- Modified Clinical Test of Sensory Interaction for Balance 
MET   
– Metabolic Equivalent of Task 
PI 
 
- Principal Investigator 
RR 
 
- Relative Risk 
TUG   
– Timed Up and Go  
VEDGE 
- Vestibular Evidence Database to Guide Effectiveness 
VOR  
- Vestibuloocular Reflex 
VR  
 
– Vestibular Rehabilitation 
VRW  
- Vestibular Rehabilitation plus Walking instruction only 
VRWP  
- Vestibular Rehabilitation plus Walking plus Pedometer 
 

 
 
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Introduction 
 
This document is a protocol for a human research study. This study is to be conducted in 
accordance with applicable Federal regulations and institutional research policies and 
procedures.  
 
Background Information and Scientific Rationale 
 
Dizziness is a common complaint reported by 30% of people above 65 years of age and by more 
than 50% of those 90 years of age and older.1 The incidence increases with age because of the 
deterioration of the vestibular system. Age-related changes in the vestibular system are 
characterized by degeneration of vestibular receptors, decrease nerve conduction of vestibular 
nerve, 2 aging otolithic membrane, alterations in calcium metabolism and microvascular 
ischemia. 3 Disorders of the vestibular system are responsible for 40 to 50% of dizziness, and 
peripheral vestibular disorders in older adults are common. 4  Aside from vestibular sources, 
dizziness can be from nonvestibular sources that include, but not limited to, sensory loss, 
psychiatric and cardiovascular disorders, and adverse drug effects.5 The majority of older adults 
with dizziness who live in the community have more than one underlying causes of dizziness.6  
  
Rotational sensation or vertigo is one of the four types of dizziness. The other types are 
impending faint, disequilibrium, and vague lightheadedness. Vertigo results from a disorder of 
the vestibular system.7 It is often accompanied by nausea, vomiting, staggering gait, and 
oscillopsia.5 It can be from a peripheral or central origin, or mixed. Peripheral vestibular 
conditions that could affect the older adults include acute or recurrent vestibulopathy, Meniere's 
disease, unilateral or bilateral vestibular dysfunction, benign paroxysmal positional vertigo 
(BPPV), and postsurgical conditions affecting the vestibule or vestibular nerve. Patients with 
central causes of vertigo are harder to treat 4 because of concomitant signs and symptoms aside 
from the complaints of dizziness. Parkinson's disease (PD), Multiple Sclerosis (MS), head 
injuries and cerebrovascular disorders can be central causes of vertigo or dizziness.4 
 
Age-related decline in vestibular, musculoskeletal, and neurologic performances compounded by 
a vestibular pathology can result to debilitating physical and psychological consequences. 
Dizziness is associated with an increased risk of falls.8 Medical conditions such as unilateral and 
bilateral vestibular deficits produce unsteadiness of gait associated with head turns, walking in 
the dark, or walking on uneven surfaces.5  
 
According to Menant and colleague, community dwelling older adults with dizziness have higher 
rate of falls.9 Dizzy older adults were 1.6 times more likely to experience multiple falls (RR1.55, 
95% confidence interval 1.08-2.23).9 Liston and colleagues found that community dwelling older 
adults experiencing multiple falls have peripheral vestibular dysfunction.8 
 
Research indicates dizziness to be independently associated with disability in the aged. The 
components of disability in the study conducted by Mueller and colleagues were limitations in 
social participation and activities of daily living. Patients with dizziness have restrictions in 
functional independence indoors and outdoors. Walking in and outside the home is a mobility 

 
 
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issue due to actual and perceived balance problems. This disabling condition is often 
accompanied by depression and anxiety.10  
 
Dizziness can cause physical inactivity.  Aside from being a risk factor for falls, the fear of 
falling or anticipation of a dizziness episode limits mobility.11 Physical inactivity leads to a 
further reduction in vestibular function. Regular physical activity stimulates or maintains gaze 
control and posture stabilization in the older adults. 12 Therefore, the lack of mobility may lead to 
a decrease in responsiveness in the neurosensory systems. Vestibular disorders can also 
significantly decrease balance confidence. 13 The cycle of activity restriction can bring about 
sedentary lifestyle, which further hastens deconditioning, frailty, and disablement in the older 
adults.11 People with dizziness may have low quality of life from the consequent loss of function 
and independence, however; there is currently no research on interventions to increase physical 
activity in older adults with dizziness. 
 
Dondzila et al. found that older adults who considered themselves physically active actually walk 
more than those who do not rate themselves as physically active.14 The Physical Activity 
Guidelines for Americans recommend 150 minutes each week of moderate intensity aerobic 
activity or 75 minutes each week of vigorous intensity aerobic activity.15 The Centers for Disease 
Control and Prevention (CDC) reported that “1 out of 5 adults (21%) meet the 2008 Physical 
Activity Guidelines”.16 For the older adults, the threshold amount of physical activity associated 
with better physical health is >8000 steps/day and/or >20min/day at an intensity of >3 Metabolic 
Equivalent (METS) and for better mental health, >4000 steps/day and/or >5min/day at 
>3METS.17 Men aged 65-69 years performed the highest steps per day (>9,126 steps/day) and 
women aged 85+years were in the lowest category of steps per day (<276 steps/day).18 
  
Currently, 10,000 steps per day is a widely promoted dosage-based walking program. In older 
adults, increased lower and upper body strength, endurance, lower body flexibility, and 
agility/balance were significantly and positively associated with walking 6500 or more steps per 
day.19 Low-activity, non-depressed older adults were able to maintain and/or improve their 
mental health.20 High volume of steps led to an increase in the Timed Up and Go (TUG) score, 
30-second leg lifts and 2-minute walking distance.21 
 
Because of the detrimental effects of sedentary lifestyle, interventions to increase physical 
activity are a public health priority.22 There are many instruments available to track the amount 
of physical activity of an individual subjectively and objectively.23 A self-report physical activity 
questionnaire is a cost-effective method to obtain physical activity data. The International 
Physical Activity Questionnaire (IPAQ) is the most commonly used physical activity 
questionnaire worldwide. It has two versions, a 31-item long form and the nine-item short form. 
The short form records the amount of time spent in sitting, walking, moderate- and vigorous-
intensity activities in the last 7 days.24 
 
Vestibular Rehabilitation (VR) is a program consisting of exercises designed to address the 
impairments, functional limitations, and disability from vestibular hypofunction. Walking for 
endurance is cited as one of the components of vestibular rehabilitation in the “Clinical Practice 
Guideline for Peripheral Vestibular Hypofunction” together with gaze stability, habituation, and 

 
 
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balance training.25 Aside from the general conditioning value of walking as an exercise, walking 
develops or maintains the efficiency of the two vestibular reflexes, consisting of the 
vestibulospinal and vestibuloocular reflexes involved in postural control.12 Walking involves 
sensory integration of inputs from visual, vestibular and somatosensory for controlled translation 
of the center of gravity. In addition, walking is a form of physical activity accessible to all 
persons regardless of socioeconomic status. Although walking can offset the avoidance of 
physical activity from symptom provocation, no direct evidence has been found to support the 
effect of walking on postural and dynamic stability, function, and participation in people with 
dizziness.25   
 
 
To evaluate the effectiveness of vestibular rehabilitation, various outcome measures have been 
utilized in the literature. Guided by the International Classification of Functioning, Disability and 
Health (ICF) as the biopsychosocial model, The Academy for Neurologic Physical Therapy 
created The Vestibular Evidence Database to Guide Effectiveness (VEDGE) task force that 
evaluated the domains targeted in vestibular rehabilitation namely:  body structures and functions 
(postural stability, dynamic stability, gaze stability, VOR function), activity and participation 
restrictions and symptom severity. Among the outcome measures recommended by the task force 
are the Dynamic Gait Index (DGI), Timed Up and Go (TUG) tests, and Modified Clinical Test of 
Sensory Integration of Balance (mCTSIB) for postural or dynamic stability, and the Dizziness 
Handicap Inventory (DHI) for activity or participation for the general vestibular population.26  
 
The TUG test assesses balance, walking ability, and fall risk in older adults. The cut-off scores 
indicating risk for falls have been established for community-dwelling older adults (13.5 
seconds),27 frail elderly (32.6 seconds)28 and vestibular disorder (11.1 seconds).29  It was found to 
have adequate to good psychometric properties and clinical utilities for acute, chronic, central 
and peripheral vestibular disorder.26 Two cross-sectional studies tested the reliability of TUG in 
older adults with dizziness. The first was by Marchetti and colleagues who found moderately 
strong significant correlation between TUG and Activities-Specific Balance Confidence (ABC) 
scale.30 Another study found significant negative correlation between TUG and the Mini Mental 
State Examination in elderly patients with chronic peripheral vestibular disease.31 No studies to 
date tested the test-retest reliability of the TUG in older adults with dizziness. 
 
The DHI is a 25-item self-assessment questionnaire to evaluate perceived disability from the 
dizziness.32 This outcome measure is at the level of participation on the ICF. The VEDGE 
document reports that the DHI has a good to excellent psychometric properties and clinical 
utilities.26 It has an adequate correlation with the DGI, a tool that assesses balance while walking 
in the presence of external demands,33 and TUG test in subjects with multiple sclerosis.34 The 
DHI is also found to have excellent correlation with Sensory Organization Test (SOT) composite 
score in individuals with vestibular neuritis.35 The SOT equipment is used to objectively measure 
postural control but clinically, it is costly,36 time- and space-consuming. An alternative test that 
was developed for postural control is the mCTSIB,36 which is more practical than the SOT. In a 
study conducted by Whitney and Wrisley on mCTSIB, an abnormal mCTSIB has shown scores 
indicating greater amount of impairment in the DHI.37 The predictive validity of TUG, DGI, and 
mCTSIB on disability as shown by DHI has not been established in older adults with dizziness. 
 

 
 
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Study Objectives 
 
There are four purposes to this study. The primary purpose of this study is to evaluate the impact 
of walking as an exercise component of VR on both primary and secondary vestibular-specific 
outcome measures. The primary outcomes are mCTSIB, TUG test, DGI, and DHI, while the 
secondary outcomes are the total number of visits and length of interventions (in weeks). The 
second purpose is to evaluate whether pedometers increase the adherence of older adults with 
vestibular issues to a walking program. This will be measured by change in physical activity, as 
represented by International Physical Activity Questionnaire (IPAQ) Walking Metabolic 
Equivalent of Task (MET)-minutes/week and IPAQ Total Physical Activity MET-minutes/week 
scores from the IPAQ short form during the episode of care (admission and discharge) and on 
four-weeks follow-up compared to those patients who only received instructions to walk without 
a pedometer. The third purpose of this study is to establish test-retest reliability of the TUG test 
on older adults with dizziness. Lastly, the fourth purpose of this study to investigate if the TUG, 
DGI, and mCTSIB are significant and strong predictors of the DHI in older adults with dizziness. 
Protocol #1365169 “Predictors of Disability in the Older Adults” is being performed to 
supplement the number of subjects for the fourth objective of this study. 
 
 
 
Study Design 
 
Research Design 
  
1. Experimental Design. To answer the first and second study objectives, a 
pragmatic, randomized, prospective, clinical study on 54 older adults with dizziness will 
be utilized. This will be conducted at Florida Hospital Sports Medicine and 
Rehabilitation locations that offer vestibular therapy. These are in East Orlando and 
Winter Park. 
2. Correlation Design. A correlation analysis will be performed on the data 
collected on 54 subjects in the experimental design to establish the test-retest reliability 
of the Timed Up and Go.   
3. Cross-sectional Descriptive Design. A regression analysis will be performed on three 
predictors of the Dizziness Handicap Inventory, obtained from the data collected on 54 
subjects in the experimental design and from Florida Hospital Sports Medicine and 
Rehabilitation Physical Therapy medical charts from June 2015 to June 2018 that met the 
inclusion and exclusion criteria that were outlined in the Protocol #1365169. 
.  
 

 
 
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Study Agent, Device, and/or Intervention Description  
 
54 participants will receive vestibular rehabilitation as prescribed by the treating 
therapists. Vestibular Rehabilitation is composed of four different exercise components: 
gaze stability, habituation, balance training and general conditioning.25 Two of the 
intervention groups will receive vestibular rehabilitation plus walking with and without 
pedometer while the third intervention group will be vestibular rehabilitation only. 
 
Study Site(s)/Location(s) and Number of Subjects 
 
Subjects will be recruited through consecutive admissions at participating Florida 
Hospital outpatient departments until the target total number of subjects who met the 
inclusion and exclusion criteria is achieved (n=54).  
 
 
Florida Hospital site locations: 
 
The research will be conducted at Florida Hospital Sports Medicine and Rehabilitation 
locations that offer vestibular therapy. These are in East Orlando and Winter Park. 
Estimated number of subjects in each location is 27 subjects who met the inclusion and 
exclusion criteria.  
 
 
Name of external site(s) outside of Florida Hospital: 
  
N/A 
 
Total number of all sites:  
 
Estimated number of subjects at all sites combined is 54. 
 
Multi-Site Research Logistics/Communication Plan 
 
To streamline communication among sites, the PI will communicate online or in 
person to all sites’ research staff the following information once they are available and 
during the monthly meetings: most current version of the protocol and consent form, 
reportable new information, amendments, and study progress. All modifications must be 
communicated to sites, and approved before the modification is implemented. Electronic 
and paper research data will be submitted to the study coordinator. The study coordinator 
will keep all research data in a locked filing cabinet in Florida Hospital and all electronic 
data in a password protected Florida Hospital computer. The study coordinator will 
ensure that the study is conducted by the research staff appropriately and will report non-
compliance with the study protocol or applicable requirements in accordance with local 
policy to the PI and IRB. Problem, interim results, and closure of the study will be 
communicated to the study coordinator and PI.  
 

 
 
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Research Conducted in a Foreign Country 
N/A 
 
Community-Based Participatory Research 
N/A 
 
Subject Selection 
 
Vulnerable Populations (if applicable) 
 N/A 
 
Inclusion Criteria 
1. Age 65 years or older referred for physical therapy evaluation for symptoms of dizziness, 
postural instability, or both 
2. Able to walk without the physical help of another person, with or with no assistive device 
3. Able to follow commands and execute the examination and intervention instructions in 
the English language 
4. Willing to participate in a phone interview four weeks after discharge 
5. Able to provide informed consent 
 
Exclusion Criteria 
1. Unstable medical issues, such as unstable or uncontrolled cardiovascular conditions, 
elevated blood pressure (Systolic greater than or equal to 140mmHg and diastolic greater 
than or equal to 90mmHg), orthostatic hypotension (a fall in systolic blood pressure of at 
least 20mmHg or diastolic blood pressure of at least 10mmHg when a person stands from 
a sitting or lying down position), uncontrolled metabolic disease, as determined by the 
evaluating physical therapist, documented in the Functional Comorbidity Index, vital 
signs and assessment portion of the initial evaluation.  
2. History of falls from syncopal origin 
3. Dizziness of central origin, such as stroke, head injuries, MS or PD;  
4. Active BPPV (patients with positive dix hallpike and/or roll test) 
5. Inability to walk without physical assistance. 
 
Resources Available 
 
Each site will have research staff (treating physical therapists). Prior to enrollment 
of subjects, training of the study coordinator and research staff will be conducted onsite 
or online by the principal investigator. This training will cover the following: multi-site 
communication, subject recruitment, informed consent, inclusion and exclusion criteria 
and data collection. Research staff will receive instructions on randomization, 
interventions, outcome measures, and the use of Fitbit Zip pedometer. To establish 
interrater reliability, participating therapists will rate the DGI, mCTSIB and TUG by 
watching a video of a volunteer patient, and the DHI and IPAQ short form sample 

 
 
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questionnaires. To ensure compliance with the outcome measure equipment, research 
staff will sign a Research Equipment Compliance Document. The principal investigator 
will conduct inspection of equipment in each site, co-sign the document and keep the 
paper record in a locked filing cabinet in Florida Hospital. 
 
 
Principal Investigator: The PI will prepare, coordinate, conduct training onsite or online on each 
clinical site for protocol setting, and facilitate monthly meetings. The PI is one of the treating 
therapists. The PI will keep all electronic and paper based research data for seven years after data 
collection is completed. 
 
Study coordinator:  The study coordinator will keep all electronic and paper based research data 
until data collection is completed, and will conduct follow-up phone calls after four weeks of 
discharge to obtain the IPAQ scores. The study coordinator will perform review preparatory to 
research and will be mailing letter of invitation and informed consent form to potential 
participants prior to initial evaluation. Once a signed consent form is obtained, the study 
coordinator will conduct a retrospective chart review on the subject’s initial evaluation and first 
follow-up visit if applicable, complete the Inclusion/Exclusion form, and determine the 
eligibility of the subject to participate in the study. The Study Coordinator is expected to attend 
the monthly meeting. 
 
Research Staff: Treating physical therapists are expected to undergo training during the protocol 
setting and to attend the monthly meeting. They are responsible in recruiting participants, 
obtaining informed consent, conducting follow-up phone call prior to next visit, collecting the 
outcome scores for DGI, TUG, DHI, mCTSIB, IPAQ-short form questionnaire, and 
implementing the interventions.  
 
Research Assistant. The Research Assistant can conduct a follow-up phone call to a potential 
participant to give opportunity for questions. This responsibility will be given to the research 
assistant upon completion of an informed consent training conducted by the principal 
investigator and passing a compentency test on the informed consent. 
 
Data Analysts: Electronic research data of the outcome measures will be forwarded to the data 
analysts from Adventist University for statistical analysis. 
 
Equipment: The pedometers will be donated to the 54 participants who met the inclusion and 
exclusion criteria and randomized into one of the treatment groups, as a reward for participating 
in the research study and for them to perpetuate their physical activity.  
 
Office and Filing Supplies: Under this category are office supplies for advertisement, 
recruitment, informed consent and outcome measure forms, training manuals, filing of 
research data. 
 
Shipping and Mailing Fees: These cover mailing of letter of invitations, result of the study and 
shipping of pedometers to participants who did not belong to the VRPW group. 

 
 
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Study Procedures 
 
Subject Recruitment and Screening 
 
The advertisement will contain brief information about the research project, 
inclusion criteria and contact information of the study coordinator and principal 
investigator for inquiries. Advertisement on the study will be in the form of the following: 
electronic flyers, print out flyers, news article and emails. The electronic flyer and news 
article will be disseminated as email attachment and links respectively, sent to referring 
physicians and senior groups in the community and postings in social media such as Florida 
Hospital Facebook page. The news article will be submitted to the Florida Hospital Sports 
Medicine and Rehabilitation newsletter. 
 
The print out flyers will be posted at the reception area of participating clinics, 
doctor offices and senior group locations. The study coordinator will perform review 
preparatory to research for Florida Hospital sites. He will be mailing letter of invitation and 
informed consent form to potential participants prior to initial evaluation. The study 
coordinator or treating physical therapist will be giving letter of invitation and informed 
consent form to potential participants before or after the initial evaluation.  
 
Consent Process  
 
Informed Consent of subjects will be obtained in writing following HRP-802 
INVESTIGATOR GUIDANCE: Informed Consent. This will be documented following 
the INVESTIGATOR GUIDANCE: Documentation of Informed Consent (HRP-803). 
 
Documentation of Informed Consent Process 
 
Documentation of the informed consent process is required to establish that the 
subject was accurately and adequately informed and that no study-related procedures 
were initiated prior to obtaining informed consent. The research staff will complete the 
Documentation of Informed Consent Form (HRP-803) that contains the consent progress, 
date consent was obtained and that consent was obtained prior to initiating any research 
procedures. The research staff will explain the consent form to interested patients. A 
follow-up phone will be conducted by the principal investigator, research assistant or 
research staff to the potential participant prior to the beginning of the tenth visit. If the 
patient expressed willingness to take part in the research, the research staff will obtain a 
signature of subject during patient’s visit/a face-to-face encounter with the patient. The 
study coordinator will perform a retrospective chart review on the subject’s medical chart 
once a signed informed consent form is obtained.  
 
Randomization 
 
For the experimental design, block randomization will be performed to ensure 

 
 
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equal number of participants in each treatment group. The study coordinators will have a 
prerandomized masterlist of subjects generated using an online randomization program 
(https://www.sealedenvelope.com/simple-randomiser/v1/lists). The signed informed 
consent must be returned prior to tenth visit. Once the study coordinator confirmed that 
the subject is eligible to participate in the study by completing the Inclusion/Exclusion 
Form based on the retrospective chart review of the patient’s medical record, he will 
assign the subject with an ID number and randomize the subject into one of the three 
groups as determined by the prerandomized master list: first intervention group (n=18, 
VR plus walking with pedometer, VRWP), second intervention group (n=18, VR plus 
walking instruction only, VRW) and control group (n=18, usual care, VR). The study 
coordinator will keep paper and electronic records that contain the list of research 
numbers with names of all the subjects, date of birth and medical record number. 
 
The VRWP group will have VR with an instruction to increase their number of steps 
daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer 
group). They will receive pedometers (Fitbit Zip), instructions on how to use the 
pedometer, step log forms, with home instruction handout to walk more at least more 
than ten minutes at a time. This group will be instructed to wear a pedometer on or below 
the waist such as belt, waistband, or in trousers’ pocket, during waking hours, all day, 
except for bathing or swimming. A clip designed to keep the Fitbit Zip clipped to the 
clothing will be provided. There is no charging time. Fitbit Zip uses a replaceable watch 
battery that can last up to 6 months. The participants will record on their activity log the 
number of steps shown on the step display at the end of the day. The Fitbit Zip will be 
device inclusive. Subjects will not be given instruction to program their information or 
synchronize their Fitbit Zip with an application software on a smart phone, tablet, or any 
computer device. The daily step log form will be given to the research staff every visit for 
recording. The research staff will encourage their participants to increase their daily steps 
at least 10% until they achieve at least 3,000 steps daily. The older adults in the group 
will be trained on how to use the pedometers before they take them home, and will have 
the opportunity to review this instruction with the research staff on consecutive visits if 
needed. There may be cost associated with the study in case of lost or malfunction from 
using the pedometer due to the subject will be encouraged but not required to replace the 
pedometer. The subject will continue to be the VRWP group and this situation will be 
reported in the discussion of results. 
The VRW group will receive VR and a time-based instruction to walk more daily at least 
10 minutes at a time (VR plus walking no pedometer group). This group will be instructed 
on the benefits of walking (similar to the first group) but will not be given the pedometer. 
They will have home instruction handouts to walk more at least more than ten minutes at 
a time and a walking log sheet. The research staff will instruct their participants to increase 
their daily time at least 10% until they achieve at least 30 minutes of walking exercise 
daily. The walking log sheet form will be given to the research staff by the participant every 
visit for recording. 
 

 
 
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The VR (control) group will follow the conventional VR physical therapy without the 
encouragement of walking and without specification of walking in the home exercise 
program.  
 
The use of an assistive device can be recommended for any subject in any group by the 
research staff to maximize safety. The patient may need to purchase the assistive device. 
 
Participants who do not belong to the intervention group with pedometer will receive a 
pedometer after they completed the study. They will receive instructions on how to use the 
pedometer prior or on the day of their last visit. 
 
Study Visits  
 
For the experimental design that will be conducted at Florida Hospital locations, the 
following data will be collected as standard of care by the physical therapist during initial 
evaluation, and if more time is needed, during the first follow-up physical therapy 
appointment: mCTSIB, TUG, DGI, DHI, age, gender, body mass index, home situation, 
Functional Comorbidity Index (FCI) total, ability to drive, medications and insurance 
type.   After the subject signs the informed consent, the study coordinator will be notified 
by the research staff to conduct a retrospective chart review on the physical therapy initial 
evaluation and first follow-up visit, if applicable, of the subject. The study coordinator 
will extract the following baseline measurements from the subject’s medical record: DGI, 
mCTSIB, DHI, TUG and socio-demographic data that include age, gender, body mass 
index, home situation (lives alone or with social support), Functional Comorbidity Index 
(FCI) total, ability to drive (able or unable), medications for vertigo and insurance type 
(Medicare/Non-medicare). Based on the retrospective chart review, the study coordinator 
will determine if the subject is eligible to participate in the study.  
 
Visit 1: Once the study coordinator determined that the subject is eligible to participate in 
the study, the subject will be assigned a research number and will be randomized into one 
of the three intervention groups. The research staff can initiate or continue the VR 
program. For the test-retest reliability of the TUG test, there will be one practice trial 
followed by two final performances that will be included in the data analysis. The subject 
will also be asked to complete the IPAQ-short form questionnaire. The test-retest 
reliability of TUG and the IPAQ-short form questionnaire are for research purposes only. 
 
Visit 2: The research staff can initiate the research intervention according to the 
intervention group. 
 
Visit 3 to visit prior to discharge: The research staff can continue the VR and intervention 
according to the intervention group.  
 
Discharge or last visit: All outcome measures (DGI, TUG, mCTSIB, DHI and IPAQ) will 
be reassessed. Discharge scores for DGI, TUG, mCTSIB and DHI are standard of care, 
while IPAQ is for research purposes only. The total number of visits and length of 

 
 
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interventions (in weeks) for every participant will be recorded as secondary outcome 
measures. These research data will be forwarded to the study coordinator, and will be 
stored in a locked cabinet and password protected Florida Hospital computer.  
 
Four-weeks after discharge: The study coordinator will conduct a follow up phone call to 
all subjects four weeks after discharge summary is completed to obtain the level of 
physical activity using the IPAQ short form questionnaire. This is for research purposes 
only. A follow-up on a subject will be discontinued if a subject is not reached after three 
attempts of follow-up phone call made on three different days between 30 and 45 days. 
Data analysis will commence once all the data from 54 subjects are collected. 
 
Table 1.  Summary of Interventions for VRWP, VRW and VR Groups. 
VRWP (n=18) 
VRW (n=18) 
VR (n=18) 
• Visit 1: Test-retest 
of TUG. Subject 
will complete the 
IPAQ-short form. 
Randomization. 
Initiate or continue 
with VR. 
• Visit 2:  initiate HEP 
on walking with 
pedometer. Patients 
will be given a 
pedometer and 
instruction on how 
to use it. Participants 
will be encouraged 
to increase their 
daily steps at least 
10% until they 
achieve at least 
3,000 steps daily. 
• Visit 3 to visit prior 
to discharge: 
Continue with VR. 
Continue with 
instruction on how 
to use the Fitbit Zip 
pedometer as 
needed. Treating 
therapist will 
monitor and keep a 
record of the 
• Visit 1: Test-retest 
of TUG. Subject 
will complete the 
IPAQ-short form. 
Randomization. 
Initiate or continue 
with VR. 
• Visit 2: Initiate HEP 
on time-based 
walking. Patients 
will be instructed to 
walk at least 10 
minutes at a time. 
Participants will be 
encouraged to 
increase their daily 
steps at least 10% 
until they achieve at 
least 30 minutes of 
walking exercise 
daily. 
• Visit 3 to visit prior 
to discharge: 
Continue with VR. 
Treating therapist 
will monitor and 
keep a record of the 
patient’s daily step 
log form every visit. 
• Discharge day: 
mCTSIB, DGI, 
• Visit 1: Test-retest 
of TUG. Subject 
will complete the 
IPAQ-short form. 
Randomization. 
Initiate or Continue 
with VR. 
• Visit 2 to Visit prior 
to discharge: 
Continue with VR, 
without the 
encouragement of 
walking and without 
specification of 
walking in the home 
exercise program.  
• Discharge day: 
mCTSIB, DGI, 
DHI, TUG and 
IPAQ short form, 
total number of 
visits and length of 
intervention (in 
weeks).  
• Four-week follow-
up: phone call for 
IPAQ short form 
• Pedometers will be 
mailed to 
participants as a 
reward for 

 
 
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patient’s daily step 
log form every visit.  
• Discharge day: 
mCTSIB, DGI, 
DHI, TUG and 
IPAQ short form, 
total number of 
visits and length of 
intervention (in 
weeks) 
• Four-week follow-
up: phone call for 
IPAQ short form 
DHI, TUG and 
IPAQ short form, 
total number of 
visits and length of 
intervention (in 
weeks).  
• Four-week follow-
up: phone call for 
IPAQ short form 
• Pedometers will be 
mailed to 
participants as a 
reward for 
participation. 
participation. 
 
 
 
 
 
Study Duration 
 
TIMELINE 
 
Month Task 
2017 
Dec 
2018 
Jan 
 
Feb 
 
Mar 
 
Apr 
 
May 
 
June 
IRB 
Submission 
X 
 
 
 
 
 
 
Protocol Set 
X 
 
 
 
 
 
 
Completion of 
Training 
Requirements 
by 
Research 
Personnel 
X 
 
 
 
 
 
 
Subject 
Enrollment 
 
X 
X 
X 
X 
X 
X 
Data 
Collection 
 
X 
X 
X 
X 
X 
X 
Data Analysis 
 
 
 
 
 
 
 
Interpretation 
 
 
 
 
 
 
 
Dissemination 
 
 
 
 
 
 
 
 
Month Task 
2018 
July 
 
Aug 
 
Sept 
 
Oct 
 
Nov 
 
Dec 
2019 
Jan 
IRB 
 
 
 
 
 
 
 

 
 
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Submission 
Protocol Set 
 
 
 
 
 
 
 
Completion of 
Training 
Requirements 
by 
Research 
Personnel 
 
 
 
 
 
 
 
Subject 
Enrollment 
X 
X 
 
 
 
 
 
Data 
Collection 
X 
X 
 
 
 
 
 
Data Analysis 
 
 
X 
X 
 
 
 
Interpretation 
 
 
X 
X 
 
 
 
Dissemination 
 
 
 
 
X 
X 
X 
 
 
Materials of Human Origin:  Collection, Preparation, Handling and Shipping 
N/A 
 
 
Study Outcome Measures (Endpoints) 
 
The DHI is a 25-item self-report questionnaire that quantifies the functional, emotional and 
physical impact of dizziness. Answers are graded 0 for no, 2 for sometimes and 4 for yes, with a 
maximum total score of 100. Interpretations are mild dizziness for scores between 0-30, moderate 
for 31-60 and severe for 61-100.32 DHI has been found to have excellent negative correlation (r=-
0.64) with the Activity Specific Balance Confidence Scale (ABC) in the elderly.39 For the 
population with vestibular dysfunction, it has excellent correlation with ABC (r=-0.64) 39 and SF-
36 (r=0.53-0.72),40 and moderate statistically significant negative correlation with Sensory 
Organization Test conditions 2 (r=-0.39), 4 (r=-0.36), 5 (r=-0.42) and 6 (r=-0.35).41 The Minimal 
Detectable Change (MDC) for peripheral and central vestibular pathology is 17.18 points and the 
Minimally Clinically Important Difference (MCID) for vestibular dysfunction is at least 18 points 
between the pretreatment and post-treatment scores.32 The MDC and MCID scores for older adults 
with dizziness are not established. 
  
The TUG is a test of balance and risk for falls.27 This test measures the time it takes to walk 3 
meters starting from a sitting position and it ends when the patient is seated again. Among the 
population studied for the TUG are the frail elderly and vestibular disorders.42 The cut-off scores 
that indicate risk for falls are greater than 13.5 seconds for community dwelling older adults 27 
and greater than 11.1 seconds for vestibular disorders.29 It has an excellent inter-rater reliability 
for elderly adults.43 Podsiadlo and Richardson found that in the elderly adults, the TUG has 
excellent correlation with Berg Balance (r=-0.81), gait speed (r=-0.61), and Barthel Index of 
ADL (r=-0.78).42 It has 80% sensitivity and 56% specificity in falls prediction for vestibulopathic 
elderly.29 MDCs have been established for Alzheimer’s Disease (4.09 seconds) 44  and 

 
 
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Parkinson’s Disease (3.5 to 11 seconds).45-47 There is no established MDC for older adults with 
dizziness. 
   
The DGI assesses the ability to maintain balance while walking in the presence of external 
demands. It is scored based on a 4-point ordinal scale (3=no gait dysfunction, 2=minimal 
impairment, 1=moderate impairment and 0=severe impairment) with the highest possible score 
of 24.33 A cut-off score of less than 19 is indicative of increased fall risks in community-dwelling 
elderlies.48 It has an excellent intrarater (ICC=0.89) and interrater (ICC=0.82) reliability for 
community dwelling older adults with baseline impairment 49 and adequate inter-rater reliability 
(k=0.64) for the vestibular population.33 It has excellent correlation with Balance Self-
Perceptions test (r=0.76) and Berg Balance Test (r=0.67) and adequate correlation with assistive 
devices history (r=-0.44) and history of imbalance (r=-0.46) in community dwelling older 
adults;48 and excellent concurrent validity with the Berg Balance Scale (r=0.71) in the vestibular 
population.50  
  
The mCTSIB quantifies the ability of the patient to use information from somatosensory, visual 
and vestibular system effectively for postural stability. This test eliminated conditions 3 and 6 of 
the original CTSIB, which use an altered visual input (visual conflict dome). It is performed with 
the feet together, a modification from the original test, which is with feet apart.51 The four 
conditions of mCTSIB are standing on firm surface eyes open, standing on firm surface eyes 
closed, standing on compliant surface eyes open, and standing on compliant surface eyes closed. 
The patient is timed for 30 seconds and the average score of three trials is obtained. It only 
requires a timer and balance foam to administer the test. It has been found to have good 
agreement (kappa values 0.53-0.81) between two testers and is considered as a less costly 
alternative to computerized analysis of balance.36 There is no established MDC and MCID on 
mCTSIB for older adults with dizziness.  
   
The IPAQ short form is an instrument evaluation tool of physical activity among the adults. It 
has three categories: low, moderate and high. The specific type of activities assessed are 
walking, moderate intensity activities and vigorous intensity activities. All continuous scores are 
expressed in MET-minutes/week with walking =3.3 METs, Moderate PA=4.0 METs and 
Vigorous PA = 8.0 METs. An overall total physical activity score can be computed as the sum of 
the total MET-minutes/week scores.23 This outcome measure will be used to compare the pre- 
and post-intervention physical activity level of the participants. The total time walked per week 
item of the IPAQ short form has a test-retest reliability of 0.72 using Spearman Correlation. 52 
   
Data Management and Quality Plan 
 
Data De-identification 
 
Each subject will be assigned a research number for data de-identification. The 
research number is based on the randomization list generated by the online randomization 
program (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The list of names 
with corresponding research numbers will be kept in a locked cabinet in Florida Hospital 
and password protected Florida Hospital computer by the study coordinator 

 
 
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Data Confidentiality, Storage, and Retention 
 
The Research Staff will keep the paper records of the following: Informed 
Consent, Documentation of Informed Consent Form, Visits Chart, Completed Research 
Subject Profile and Data Collection Flowsheet Form on each subject who met the 
inclusion/exclusion criteria and were randomized into one of the treatment groups in a 
locked filing cabinet in Florida Hospital.  The study coordinator will keep all paper 
records of Review Preparatory for Research Masterlist, Inclusion/Exclusion Form, 
Research Subject Database and Florida Hospital Study Coordinator Data Collection 
Flowsheet in a locked filing cabinet in Florida Hospital and store the electronic records of 
Review Preparatory for Research Masterlist and Research Subject Database in a 
password protected Florida Hospital computer until data collection is completed. Once 
data collection in a research site is complete, the study coordinator will collect all paper 
forms personally from the Research Staff. The study coordinator will forward all paper 
and electronic records to the principal investigator, and delete all electronic records from 
his secured computer. The principal investigator will complete the following electronic 
excel templates for data analysis: Clinical and Sociodemographic Characteristics at 
baseline_FL Hospital; Clinical and Sociodemographic Characteristics at 
baseline_Outside Fl Hospital; Timed Up and Go Test-Retest; IPAQ Admission, 
Discharge and 4-weeks;  TUG, DGI, mCTSIB and DHI on Admission and Discharge; 
and Total Number of Visits, Length of Intervention, Step Log and Step Goal. The 
principal investigators will forward completed excel templates to the data analysts for 
statistical analysis by email. The principal investigator will keep all electronic regards in 
a secured Florida Hospital computer and all paper records in a locked filing cabinet in 
Florida Hospital for seven years after the research study has been closed. After that 
period of time, all paper records will be shredded and electronic records will be deleted in 
the computer.  
 
Data Quality  
 
N/A 
 
 
Data Sharing (outside of Florida Hospital)  
 
The principal investigator may share the research data with accreditation 
organizations and regulatory agencies, dissertation committee, and publications, medical 
meetings, or scientific journals for the purposes of completing the research study, and 
analyzing and evaluating the results. Individual patients (subjects) will not be identified 
during data sharing, and a research number will be used instead during the data sharing 
process, unless necessary to carry out the research study or required by law. 
 
Sample Size Determination 
 

 
 
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A priori power analysis predicting a large effect size (F=.25) determined that a total of 54 
subjects (18 in each group), who met the inclusion and exclusion criteria will be needed, with 
alpha at the conventional value of .05  to achieve a .80 power, that includes an assumption of a 
dropout rate of 10% . 
 
Statistical Analysis Plan 
 
The results will be presented through the following tables with supporting explanations: 
• Clinical and sociodemographic characteristics of participants by group at baseline.  
• Comparisons of TUG, DGI, mCTSIB and DHI between the three intervention groups on 
admission and discharge. 
• Comparisons of self-reported walking activity (walking MET-min/week) and total self-
reported energy expenditure (total physical activity MET-min/week) as determined from 
the IPAQ short form on admission, discharge and four-week follow-up between the three 
intervention groups 
• Comparisons of averages of compliance to step log recording and compliance rate for 
meeting step goal between the VRWP and VRW groups. Compliance is defined as low 
(<33%), moderate (33%-75%) and high (>75%) based on the step log or walking log. 
This grading of compliance was used by Hall and colleagues in their research on efficacy 
of gaze stability exercises in older adults with dizziness.53  
• Comparisons of total number of visits and length of interventions in weeks between the 
three intervention group. 
• Intraclass Correlation Coefficients for the Timed Up and Go test-retest reliability 
• Result of stepwise linear regression analysis for TUG, DGI, mCTSIB and DHI 
 
All interval and ratio data will be tested for normality prior to undertaking the data analysis. 
Descriptive statistics will be used to describe the characteristics of the sample and compare the 
three groups at baseline.  This will include Analysis of Variance (ANOVA) for parametric and 
Chi Square for nonparametric sociodemographic and clinical data. 
 
Analyses will employ five repeated measures Analysis of Covariance (ANCOVA), adjusting for 
age, with two independent variables (group and time) and five outcome measures (TUG, DGI, 
DHI, mCTSIB and IPAQ short form). The adjustment of age is based on age-related decline. 
Intraclass Correlation Coefficient will be calculated to establish the test-retest reliability of the 
TUG and a stepwise linear regression with age as covariant will be conducted for all 54 subjects 
at baseline to determine if TUG, mCTSIB and DGI are predictors of DHI. Two-tailed test will be 
utilized to compare the compliance with step log recording and meeting step goals between the 
two walking groups (VRWP and VRW), and ANOVA to compare of total number of visits and 
total length of intervention in weeks between the three groups. Alpha for all analyses will be set 
at 0.05 to test for significant difference. 
 

 
 
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Potential Risks and Benefits 
 
Potential Benefits 
 
Possible benefits include improved physical function. 
 
Potential Risks 
 
 
 
The addition of a prescribed walking program in the treatment of dizziness will challenge 
the subject’s balance, and in rare cases may result in falls or more dizziness.  
 
Performance-based outcomes such as mCTSIB, DGI, and TUG check for the subject’s 
reaction whenever in a condition of unsteadiness. The risks associated with these tests are 
the potential for falls and for dizziness. Self-report questionnaires such as the DHI and 
IPAQ will need the subject to read the questions and recall past experiences. Looking 
down and reading the questions may provoke dizziness and eye strain. Other possible 
risks for subjects are: 1) finding the questions to be sensitive 2) emotional discomfort 
(uncomfortable/embarrassed/sad/tired) and 3) distress as subject thinks of experiences. 
 
Mitigation of Risks  
 
The research staff (treating physical therapist) will supervise the treatment at all 
times to minimize any such risks.  
 
Provisions to Protect the Privacy Interest of Subjects 
 
Subjects will be assigned research numbers for study-related records and data 
sharing. The patient’s confidentiality will be protected by observing the HIPAA policies 
and procedures. 
 
Early Withdrawal of Subjects 
 
Investigator Withdrawal of Subjects 
 
The PI may terminate the participation of the subject in the study if the subject 
may be in any danger or no longer meets the inclusion criteria of the study. 
 
Subject Request for Withdrawal from Study 
 
Subjects may withdraw or take away the permission to use and disclose their 
health information for any reasons at any time. This can be done by sending a written 
notice to the PI. Information that has already been gathered may still be used or given to 
others, however no new health information that might identify the subject will be 
gathered after the subject withdraw from the study. 

 
 
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Data Collection and Follow-up for Withdrawn Subjects 
 
Patients who request withdrawal or who are withdrawn by the PI from the study 
will have their information that has already been gathered and shared in the research 
database. These data will be included in the data analysis. The percentage of patients 
withdrawing will be calculated.   
 
Adverse Event Reporting 
 
At each therapy visit of the subject, the research staff/treating therapist will seek 
information if there is any adverse event caused by taking part in the study. In the event of a 
research-related injury, the subject should report this in person or by phone to the research 
staff/treating therapist and PI. All adverse events will be reported to Florida Hospital’s IRB and 
Nova Southeastern University’s IRB following their respective policies for reporting adverse 
events.  
 
Safety Monitoring Plan   
 
Safety Monitoring 
N/A 
 
Data and Safety Monitoring Board (DSMB) or Equivalent 
N/A 
 
Ethical Considerations 
 
Subjects in the VRW and VR group will receive a pedometer after they completed the study.  
 
Sharing of Results with Subjects 
Results of the study that are part of standard physical therapy will be shared with 
subjects and referring physicians. Letters will be sent to all participants that contain the 
results of the research once the research is completed. 
 
Funding Source 
Application for funding will be done through the Adventist University in January 2018. The 
principal investigator is currently requesting managers to allow the allocation of her Continuing 
Education budget for 2018 for this study. 
 
Subject Stipends or Payments 
 
The pedometer will be donated to the 54 participants, who met the inclusion and exclusion 
criteria and randomized into one of the three treatment groups, as a reward for participating in 
the research study and for them to perpetuate their physical activity.  

 
 
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Publication Plan 
 
It is anticipated that four research papers (one for each objective) can be published from the 
research study. The PI will the primary author. The dissertation committee composed of Dr. 
Mary Blackinton, Dr. Joann Gallichio and Dr. Ann Galgon, and Dr. Leana Araujo of Adventist 
University will be the co-authors. Non-author contributors will be acknowledged and their 
specific contributions will be specified. The PI will apply for poster presentations in the local 
state and national conferences. Internal dissemination will be done through presentations within 
Florida Hospital.  
 
References 
 
1. 
Maarsingh OR, Stam H, van de Ven PM, van Schoor NM, Ridd MJ, van der Wouden JC. 
Predictors of dizziness in older persons: a 10-year prospective cohort study in the 
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2. 
Ricci NA, Aratani MC, Dona F, Macedo C, Caovilla HH, Gananca FF. A systematic 
review about the effects of the vestibular rehabilitation in middle-age and older adults. 
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3. 
Ishiyama G. Imbalance and vertigo: the aging human vestibular periphery. Seminars in 
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4. 
Alrwaily M, Whitney SL. Vestibular rehabilitation of older adults with dizziness. 
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Bovo R, Faccioli C, Martini A. Dizziness in the elderly. Hearing, Balance and 
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Fernández L, Breinbauer HA, Delano PH. Vertigo and Dizziness in the Elderly. Frontiers 
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Liston MB, Bamiou DE, Martin F, et al. Peripheral vestibular dysfunction is prevalent in 
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Menant JC, Wong A, Sturnieks DL, et al. Pain and anxiety mediate the relationship 
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Mueller M, Strobl R, Jahn K, et al. Impact of vertigo and dizziness on self-perceived 
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Mueller M, Strobl R, Jahn K, Linkohr B, Peters A, Grill E. Burden of disability 
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Gauchard GC, Gangloff P, Jeandel C, Perrin PP. Physical activity improves gaze and 
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Alghadir AH, Iqbal ZA, Whitney SL. An update on vestibular physical therapy. Journal 
of the Chinese Medical Association : JCMA. Jan 2013;76(1):1-8. 

 
 
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Dondzila CJ, Gennuso KP, Swartz AM, et al. Dose-response walking activity and 
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Centers for Disease Control and Prevention. How much physical activity do older adults 
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Centers for Disease Control and Prevention. Facts about Physical Activity.  
https://www.cdc.gov/physicalactivity/data/facts.htm. Accessed April 16, 2017. 
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Aoyagi Y, Shephard RJ. Steps per day: the road to senior health? Sports medicine 
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Tudor-Locke C, Schuna JM, Jr., Barreira TV, et al. Normative steps/day values for older 
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and medical sciences. Nov 2013;68(11):1426-1432. 
19. 
de Melo LL, Menec VH, Ready AE. Relationship of functional fitness with daily steps in 
community-dwelling older adults. Journal of geriatric physical therapy (2001). Jul-Sep 
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Patel A, Keogh JW, Kolt GS, Schofield GM. The long-term effects of a primary care 
physical activity intervention on mental health in low-active, community-dwelling older 
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Snyder A, Colvin B, Gammack JK. Pedometer use increases daily steps and functional 
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Centers for Disease Control and Prevention. The CDC Guide to Strategies to Increase 
Physical Activity in the Community. 
https://www.cdc.gov/obesity/downloads/pa_2011_web.pdf. Accessed April 16, 2017. 
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Shook RP, Gribben NC, Hand GA, et al. Subjective Estimation of Physical Activity 
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Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical 
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Hall CD, Herdman SJ, Whitney SL, et al. Vestibular Rehabilitation for Peripheral 
Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE 
AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. 
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Academy of Neurologic Physical Therapy. Vedge Measures Recommended for Research. 
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Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in 
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29. 
Whitney SL, Marchetti GF, Schade A, Wrisley DM. The sensitivity and specificity of the 
Timed "Up & Go" and the Dynamic Gait Index for self-reported falls in persons with 
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2004;14(5):397-409. 
30. 
Marchetti GF, Whitney SL, Redfern MS, Furman JM. Factors associated with balance 
confidence in older adults with health conditions affecting the balance and vestibular 
system. Archives of physical medicine and rehabilitation. Nov 2011;92(11):1884-1891. 
31. 
Caixeta GC, Dona F, Gazzola JM. Cognitive processing and body balance in elderly 
subjects with vestibular dysfunction. Brazilian journal of otorhinolaryngology. Apr 
2012;78(2):87-95. 
32. 
Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. 
Archives of otolaryngology--head & neck surgery. Apr 1990;116(4):424-427. 
33. 
Wrisley DM, Walker ML, Echternach JL, Strasnick B. Reliability of the dynamic gait 
index in people with vestibular disorders. Archives of physical medicine and 
rehabilitation. Oct 2003;84(10):1528-1533. 
34. 
Cattaneo D, Regola A, Meotti M. Validity of six balance disorders scales in persons with 
multiple sclerosis. Disability and rehabilitation. Jun 30 2006;28(12):789-795. 
35. 
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Data Analysis 
 
All statistical analyses were performed using SPSS version 26. Mean and standard 
deviation were used to describe interval and ratio data, and frequencies for nominal data. 
Statistical significance was set at alpha <0.05. Since the parameters of a normal distribution were 
not met, nonparametric statistical tests were chosen for statistical analysis. 
Objective 1. To evaluate the impact of walking as an exercise component of VR on both primary 
and secondary vestibular-specific outcome measures. 
 
 
Mean and standard deviations on the mean differences of pretest and posttest of TUG, 
DGI, DHI, and mCTSIB were calculated to compare walking (VRWP + VRW) and control 
groups (VR only). P-value was calculated using the Kruskal-Wallis test to check for between-
group differences in the primary and secondary outcomes. For within-group differences, the 
Wilcoxon Signed Rank Test was used to examine significant differences between the pretest and 
posttest.  
Objective 2. To evaluate whether pedometers increase the adherence of older adults with 
vestibular issues to a walking program. 
 
 
To compare the VRWP, VRW and VR groups, IPAQ-Walk and IPAQ-Total scores were 
categorized as improve, same or decline in pretest and posttest, posttest and four-weeks follow-
up, and pretest and four-weeks follow-up. P-value was calculated using the Kruskal-Wallis test 
to check for between-group differences of sociodemographic data, IPAQ-Walk, IPAQ-Total, 
compliance in meeting step goals and compliance in step log. Friedman’s 2-way ANOVA by 
ranks test was used to examine significant differences within the group.  
Objective 3. To establish test-retest reliability of the TUG test on older adults with dizziness. 

 
Intraclass Correlation Coefficient (ICC) was calculated using the two-way mixed model, 
consistency type on a single measure model with a 95% CI for relative reliability. For absolute 
reliability, the Standard Error of Measurement (SEM), Minimal Detectable Change (MDC) 95% 
CI, and Bland-Altman 95% level of agreement were examined. The SEM provides the range of 
scores on retesting. A smaller value of SEM means the calculated score is close to the true 
score.44 The MDC is used to reflect the true change in score that exceeded the errors of 
measurements. Both the SEM and MDC are the same units of the original measures, which 
allows easier interpretation of results when applied in the clinical practice.74  
 
The Bland-Altman plots show the distribution of the difference scores of two 
measurements around zero. The 95% level of agreement means that 95% of the difference scores 
fall within two standard deviations above or below the mean of the difference scores. Values 
closer to zero means greater reproducibility between two repeated measures.  
 
Objective 4. To investigate if the TUG, DGI, and mCTSIB are significant and strong predictors 
of the DHI in older adults with dizziness. 
 
The subjects were then grouped based on the DHI test results, using the categories 
suggested by Whitney et al: 0-30 for mild, 31-60 for moderate, and 61-100 for severe.104 This 
analysis is similar to the work of Vereeck et al84 to obtain a better picture between the dependent 
variable DHI and the independent variables: mCTSIB, TUG, and DGI. Kruskal-Wallis analysis 
was calculated to compare group means for age, mCTSIB, TUG, and DGI. The significance 
values were adjusted by the Bonferroni correction for multiple tests.  
Before the multiple linear regression analysis, assumptions were tested to establish the 
nature of the data. The obtained Durbin-Watson statistic for the analysis of the independence of 

observations is 2.639. The Durbin-Watson statistic can range from 0 to 4, with a value of 
approximately 2 to indicate that there is no correlation between residuals. The obtained value is 
close to 2, therefore it can be accepted that there is the independence of observations. The 
assumptions of homoscedasticity, normality, and multicollinearity are upheld. There is no 
presence of outliers in the data.  
The Spearman Rho correlation coefficients were calculated to establish the relationships 
between the DHI and mCTSIB, TUG and DGI. As a general guideline, the value 0.00 to .25 
indicates little to no relationship, 0.25 to 0.50 suggests fair relationship, 0.50 to 0.75 denotes 
moderate to good relationship and above .75 is considered good to excellent relationship.44 Then, 
a multiple linear regression analysis was conducted for a continuous dependent variable and 
three independent variables to identify the predictors of DHI.