DizzinessNCT03403400
"Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?"
A study testing VRWP Group and VRW Group in people with Dizziness, run by AdventHealth at 2 sites in United States.
Trial summary
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) Age-related decline in vestibular, musculoskeletal, and neurologic performances compounded by a vestibular pathology can result to debilitating physical and psychological… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dizziness
- What is being tested?
- VRWP Group and VRW Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2018to 5 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older referred for physical therapy evaluation for symptoms of dizziness, postural instability, or both
- Able to walk without the physical help of another person, with or with no assistive device
- Able to follow commands and execute the examination and intervention instructions in the English language
- Willing to participate in a phone interview four weeks after discharge
- Able to provide informed consent
Who cannot join
- 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.
- History of falls from syncopal origin
- Dizziness of central origin, such as stroke, head injuries, MS or PD;
- Active BPPV (patients with positive dix hallpike and/or roll test)
- Inability to walk without physical assistance.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Hospital East Orlando
Orlando, Florida, 32822
Florida Hospital Winter Park
Winter Park, Florida, 32792
About this study
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) 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 falls,(2) disability (3) and physical inactivity.(4) Walking for endurance is cited as one of the components of vestibular rehabilitation (VR) in the "Clinical Practice Guideline for Peripheral Vestibular Hypofunction".(5) 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.
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.
Read the detailed description
Research Design
- 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.
- 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.
- 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.
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 prior to the tenth visit, the study coordinator will be notified by the research staff to conduct a retrospective chart review of the patient's medical record. 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 and initiate the research intervention according to the intervention group. 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 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.
Sample Size Determination
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 50% .
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.(6)
- 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.
- Conditions
- Dizziness
- Being tested
- VRWP Group, VRW Group
- Medical subject headings
- Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRWP GroupBehavioural
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. The participants will record on their activity log the number of steps shown on the step display at the end of the day. 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.
VRW GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VRWP Group | Experimental | Vestibular Rehabilitation plus Walking with Pedometer Groupd Receives: Behavioral: VRWP Group |
| VRW Group | Active comparator | Vestibular Rehabilitation plus Walking without Pedometer Group Receives: Behavioral: VRW Group |
| VR Group | No intervention | Vestibular Rehabilitation Only Group. 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Clinical Test of Sensory Integration for Balance (mCTSIB)
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.(7) 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.
Measured: Change from up to week 9 of treatment to up to 16 weeks of treatment
Timed Up and Go (TUG) Test
The TUG is a test of balance and risk for falls.(8) 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.(9) The cut-off scores that indicate risk for falls are greater than 13.5 seconds for community dwelling older adults (8) and greater than 11.1 seconds for vestibular disorders.(10)
Measured: Change from up to week 9 of treatment to up to 16 weeks of treatment
Dynamic Gait Index
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.(11) A cut-off score of less than 19 is indicative of increased fall risks in community-dwelling elderlies.(12)
Measured: Change from up to week 9 of treatment to up to 16 weeks of treatment
Dizziness Handicap Inventory (DHI)
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.(13)
Measured: Change from up to week 9 of treatment to up to 16 weeks of treatment
Secondary outcomes (2)
Total Number of Visits
The total number of visits after signing the informed consent between the three intervention groups were compared.
Measured: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment
Length of Interventions in Weeks
The length of interventions in weeks between the three intervention group will be compared.
Measured: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start18 Jul 2018
- Primary completion5 Sep 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Design. To answer the study objective, 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.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Adventist University
- Responsible party
- Sponsor
- Investigators
- Mary Blackinton, EED, Study director, Nova Southeastern UniversityJoann Gallichio, DSC, Study director, Nova Southeastern UniversityAnn Galgon, PhD, Study director, University of the SciencesLeana Araujo, PhD, Study director, Adventist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403400
- Sponsor's protocol ID
- 1038487
- Status last verified
- Jun 2020
- First submitted
- 29 Dec 2017
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 community. BMC Geriatr. 2014 Dec 15;14:133. doi: 10.1186/1471-2318-14-133.
PubMed 25510936Liston MB, Bamiou DE, Martin F, Hopper A, Koohi N, Luxon L, Pavlou M. Peripheral vestibular dysfunction is prevalent in older adults experiencing multiple non-syncopal falls versus age-matched non-fallers: a pilot study. Age Ageing. 2014 Jan;43(1):38-43. doi: 10.1093/ageing/aft129. Epub 2013 Sep 15.
PubMed 24042003Mueller M, Strobl R, Jahn K, Linkohr B, Ladwig KH, Mielck A, Grill E. Impact of vertigo and dizziness on self-perceived participation and autonomy in older adults: results from the KORA-Age study. Qual Life Res. 2014 Oct;23(8):2301-8. doi: 10.1007/s11136-014-0684-x. Epub 2014 Apr 10.
PubMed 24719016Mueller M, Strobl R, Jahn K, Linkohr B, Peters A, Grill E. Burden of disability attributable to vertigo and dizziness in the aged: results from the KORA-Age study. Eur J Public Health. 2014 Oct;24(5):802-7. doi: 10.1093/eurpub/ckt171. Epub 2013 Nov 8.
PubMed 24213583Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
PubMed 26913496Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
PubMed 20588090Horn LB, Rice T, Stoskus JL, Lambert KH, Dannenbaum E, Scherer MR. Measurement Characteristics and Clinical Utility of the Clinical Test of Sensory Interaction on Balance (CTSIB) and Modified CTSIB in Individuals With Vestibular Dysfunction. Arch Phys Med Rehabil. 2015 Sep;96(9):1747-8. doi: 10.1016/j.apmr.2015.04.003. No abstract available.
PubMed 26550644Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
PubMed 10960937Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946Whitney 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 vestibular disorders. J Vestib Res. 2004;14(5):397-409.
PubMed 15598995Wrisley DM, Walker ML, Echternach JL, Strasnick B. Reliability of the dynamic gait index in people with vestibular disorders. Arch Phys Med Rehabil. 2003 Oct;84(10):1528-33. doi: 10.1016/s0003-9993(03)00274-0.
PubMed 14586922Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.
PubMed 9256869Jacobson GP, Newman CW. The development of the Dizziness Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1990 Apr;116(4):424-7. doi: 10.1001/archotol.1990.01870040046011.
PubMed 2317323Shook RP, Gribben NC, Hand GA, Paluch AE, Welk GJ, Jakicic JM, Hutto B, Burgess S, Blair SN. Subjective Estimation of Physical Activity Using the International Physical Activity Questionnaire Varies by Fitness Level. J Phys Act Health. 2016 Jan;13(1):79-86. doi: 10.1123/jpah.2014-0543. Epub 2015 Apr 21.
PubMed 25898394
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Can A Prescribed Walking Program With or Without Monitoring Impact Dizziness in the Older Adults?"
- ClinicalTrials.gov ID
- NCT03403400
- Acronym / sponsor ID
- 1038487
- Conditions
- Dizziness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Adventist University
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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 falls,(2) disability (3) and physical inactivity.(4) Walking for endurance is cited as one of the components of vestibular rehabilitation (VR) in the "Clinical Practice Guideline for Peripheral Vestibular Hypofunction".(5) 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.
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.
Detailed description
Research Design
- 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.
- 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.
- 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.
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 prior to the tenth visit, the study coordinator will be notified by the research staff to conduct a retrospective chart review of the patient's medical record. 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 and initiate the research intervention according to the intervention group. 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 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.
Sample Size Determination
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 50% .
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.(6)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental Design. To answer the study objective, 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.
| Arm | Type | Receives |
|---|---|---|
| VRWP Group | Experimental | Behavioral: VRWP GroupVestibular Rehabilitation plus Walking with Pedometer Groupd |
| VRW Group | Active comparator | Behavioral: VRW GroupVestibular Rehabilitation plus Walking without Pedometer Group |
| VR Group | No intervention | –Vestibular Rehabilitation Only Group. 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 years or older referred for physical therapy evaluation for symptoms of dizziness, postural instability, or both
- Able to walk without the physical help of another person, with or with no assistive device
- Able to follow commands and execute the examination and intervention instructions in the English language
- Willing to participate in a phone interview four weeks after discharge
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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.
- History of falls from syncopal origin
- Dizziness of central origin, such as stroke, head injuries, MS or PD;
- Active BPPV (patients with positive dix hallpike and/or roll test)
- Inability to walk without physical assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRWP GroupThe 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. The participants will record on their activity log the number of steps shown on the step display at the end of the day. 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. | Behavioural | VRWP Group |
| VRW GroupThe 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. | Behavioural | VRW Group |
Primary outcome
Modified Clinical Test of Sensory Integration for Balance (mCTSIB)
Time frame: Change from up to week 9 of treatment to up to 16 weeks of treatment
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.(7) 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.
Timed Up and Go (TUG) Test
Time frame: Change from up to week 9 of treatment to up to 16 weeks of treatment
The TUG is a test of balance and risk for falls.(8) 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.(9) The cut-off scores that indicate risk for falls are greater than 13.5 seconds for community dwelling older adults (8) and greater than 11.1 seconds for vestibular disorders.(10)
Dynamic Gait Index
Time frame: Change from up to week 9 of treatment to up to 16 weeks of treatment
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.(11) A cut-off score of less than 19 is indicative of increased fall risks in community-dwelling elderlies.(12)
Dizziness Handicap Inventory (DHI)
Time frame: Change from up to week 9 of treatment to up to 16 weeks of treatment
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.(13)
2 secondary outcomes
Total Number of Visits
Time frame: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment
Length of Interventions in Weeks
Time frame: From initial evaluation (day 1 of treatment) to up to 16 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25510936Maarsingh 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 community. BMC Geriatr. 2014 Dec 15;14:133. doi: 10.1186/1471-2318-14-133.
- Background: PubMed 24042003Liston MB, Bamiou DE, Martin F, Hopper A, Koohi N, Luxon L, Pavlou M. Peripheral vestibular dysfunction is prevalent in older adults experiencing multiple non-syncopal falls versus age-matched non-fallers: a pilot study. Age Ageing. 2014 Jan;43(1):38-43. doi: 10.1093/ageing/aft129. Epub 2013 Sep 15.
- Background: PubMed 24719016Mueller M, Strobl R, Jahn K, Linkohr B, Ladwig KH, Mielck A, Grill E. Impact of vertigo and dizziness on self-perceived participation and autonomy in older adults: results from the KORA-Age study. Qual Life Res. 2014 Oct;23(8):2301-8. doi: 10.1007/s11136-014-0684-x. Epub 2014 Apr 10.
- Background: PubMed 24213583Mueller M, Strobl R, Jahn K, Linkohr B, Peters A, Grill E. Burden of disability attributable to vertigo and dizziness in the aged: results from the KORA-Age study. Eur J Public Health. 2014 Oct;24(5):802-7. doi: 10.1093/eurpub/ckt171. Epub 2013 Nov 8.
- Background: PubMed 26913496Hall CD, Herdman SJ, Whitney SL, Cass SP, Clendaniel RA, Fife TD, Furman JM, Getchius TS, Goebel JA, Shepard NT, Woodhouse SN. Vestibular Rehabilitation for Peripheral Vestibular Hypofunction: An Evidence-Based Clinical Practice Guideline: FROM THE AMERICAN PHYSICAL THERAPY ASSOCIATION NEUROLOGY SECTION. J Neurol Phys Ther. 2016 Apr;40(2):124-55. doi: 10.1097/NPT.0000000000000120.
- Background: PubMed 20588090Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
- Background: PubMed 26550644Horn LB, Rice T, Stoskus JL, Lambert KH, Dannenbaum E, Scherer MR. Measurement Characteristics and Clinical Utility of the Clinical Test of Sensory Interaction on Balance (CTSIB) and Modified CTSIB in Individuals With Vestibular Dysfunction. Arch Phys Med Rehabil. 2015 Sep;96(9):1747-8. doi: 10.1016/j.apmr.2015.04.003. No abstract available.
- Background: PubMed 10960937Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls in community-dwelling older adults using the Timed Up & Go Test. Phys Ther. 2000 Sep;80(9):896-903.
- Background: PubMed 1991946Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
- Background: PubMed 15598995Whitney 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 vestibular disorders. J Vestib Res. 2004;14(5):397-409.
- Background: PubMed 14586922Wrisley DM, Walker ML, Echternach JL, Strasnick B. Reliability of the dynamic gait index in people with vestibular disorders. Arch Phys Med Rehabil. 2003 Oct;84(10):1528-33. doi: 10.1016/s0003-9993(03)00274-0.
- Background: PubMed 9256869Shumway-Cook A, Baldwin M, Polissar NL, Gruber W. Predicting the probability for falls in community-dwelling older adults. Phys Ther. 1997 Aug;77(8):812-9. doi: 10.1093/ptj/77.8.812.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Blackinton, EED study director
Nova Southeastern University
Joann Gallichio, DSC study director
Nova Southeastern University
Ann Galgon, PhD study director
University of the Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VRWP Group and VRW Group in people with Dizziness, run by AdventHealth at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Clinical Test of Sensory Integration for Balance (mCTSIB) (time frame: Change from up to week 9 of treatment to up to 16 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403400, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.