Alzheimer Dementia (AD)NCT03221296
Fall Prevention - Vestibular Rehabilitation
A study testing Vestibular Training (Intervention Group) in people with Alzheimer Dementia (AD) and Vascular Dementia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Dementia (AD), Vascular Dementia
- What is being tested?
- Vestibular Training (Intervention Group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2017to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Elderly people ages 65 and older
- English speaking
- Can log their participation or have a caregiver log on their behalf
- Mild/moderate dementia [(1) Alzheimer's disease, (2) small vessel vascular dementia not related to stroke and (3) mixed dementia of Alzheimer's or small vessel vascular not related to stroke] or mild/moderate cognitive impairment
- Vestibular Impairment
Who cannot join
- Neurological disease (e.g. seizures, stroke, hemorrhage, central nervous system tumor, multiple sclerosis)
- Being diagnosed with a psychiatric disorder (e.g. Major depression episode, post-traumatic stress disorder, generalized anxiety disorder, schizophrenia, bipolar disorder etc.)
- Those with a current inner ear infection
- Those with severe neck arthritis
- Those with Post-Concussion Syndrome
- Severe cognitive impairment as defined by a MoCA <15
- Following etiologies of dementia: Dementia due to Lewy bodies, Parkinson's disease, Huntington's Disease, Frontotemporal Dementia, Normal Pressure Hydrocephalous
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.
Read the detailed description
This is a feasibility study to gather preliminary data on a vestibular rehabilitation program. All participants who visit UHN memory clinic with a diagnosis of mild/moderate cognitive impairment due to Alzheimer's or vascular disease or both and have had falls will be asked to participate. If agree to be contacted they will receive a consent form.
All agreeable participants shall be screened for vestibular impairment through the following tests: Dix-Hall pike test, Head Impulse Test, Head Shake test, test of Dynamic Visual Acuity. In addition, participants will complete the MoCA to assess cognitive functioning. A score lower than 15 will exclude the participant.
After determining the population who is eligible for this study and willing to participate, participants shall move to baseline assessment. At baseline, measurements of balance, gait, and dynamic visual acuity in addition to questionnaires about dizziness felt, confidence in performing activities without falling, depression and quality of life, shall be completed.
Immediately after baseline, participants will begin their treatment arm, depending on if they have been put in the vestibular group or control group. Participants in the vestibular arm will be taught vestibular exercises and asked to perform vestibular exercises for 3 sessions daily, 3-10 minutes/session. Participation in vestibular exercises shall be recorded via a log by their caregiver. During the 12 weeks, these diaries shall be kept with the participant caregiver. Caregivers shall be followed up bi-weekly to ensure that participants are completing the exercises, and logging their participation.
At the end of the 12 weeks, participants will be reassessed with the same measures from baseline in addition to the head impulse test and test of dynamic visual acuity. The investigators shall also administer a final questionnaire (Problematic Experiences of Therapy Scale) to see what may have prevented completion of therapy or caused issues.
Participants that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.
3-months after final assessments (6 months after start), all participants shall be contacted to see if there were any falls/near fall experiences.
- Conditions
- Alzheimer Dementia (AD), Vascular Dementia
- Being tested
- Vestibular Training (Intervention Group)
- Medical subject headings
- Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Training (Intervention Group)Behavioural
Exercises three times daily, for up to approximately 20 minutes. Changes in functional status and physical status shall be measured at study onset and follow up.
| Study group | Role | What they receive |
|---|---|---|
| Vestibular Training (Intervention Group) | Experimental | For the actual intervention, participants will be asked to commit a total of approximately 20 minutes a day of vestibular exercise, divided into three separate sessions (i.e. three 7 minute sessions).
These will include eye movement exercises, walking and balancing. Every 2 weeks, there will be a slight change to the exercises to increase difficulty. (i.e. balancing on one leg or walking with head turns) Receives: Behavioral: Vestibular Training (Intervention Group) |
| Usual Care (Control group) | No intervention | Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
Measured by comparing the test score change from baseline to follow up at 3 months and again at 6 months to determine if the therapy worked
Measured: 3 months and again 6 months after baseline
Secondary outcomes (25)
Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in quality of life through The Geriatric Depression Scale (GDS)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Cognitive status through the Montreal Cognitive Assessment (MoCA)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in physical functioning through the head impulse test (HIT)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Number of patients who can successfully complete Head Impulse Test (HIT)
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Measured: 3 months
Number of patients who can successfully complete Head Shake Test (HST)
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Measured: 3 months
Number of patients who can successfully complete Dynamic Gait Index (DGI)
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Measured: 3 months
Number of patients who can successfully complete the test of dynamic visual acuity (DVA)
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Measured: 3 months
Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)
Shall be measured by percentage of test items completed
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)
Shall be measured by percentage of test items completed
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Quality of Life in Alzheimer's Disease (QOL-AD)
Shall be measured by percentage of test items completed
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Shall be measured by percentage of test items completed
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Activities Specific Balance Confidence scale (ABC)
Shall be measured by percentage of test items completed
Measured: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)
Shall be measured by percentage of test items completed
Measured: 3 months
Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)
filled out by both, or either one of, the patient or caregiver
Measured: 3 months
Attrition Rate
Will be measured as the percentage of those who reached follow-up compared to those who completed baseline
Measured: 3 months
Number of patients willing to participate
Determined by the proportion of patients saying yes out of those contacted
Measured: 3 months
Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in physical functioning through the head shake test (HST)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in physical functioning through the dynamic visual acuity (DVA)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Change in physical functioning through the dynamic gait index (DGI)
Measured by comparing the test score change from baseline to follow up at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start27 Jun 2017
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Dementia (AD)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmela Tartaglia, University Health Network, Toronto
- Investigators
- Maria C Tartaglia, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221296
- Sponsor's protocol ID
- 17-5055
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
- ClinicalTrials.gov ID
- NCT03221296
- Acronym / sponsor ID
- 17-5055
- Conditions
- Alzheimer Dementia (AD), Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.
Detailed description
This is a feasibility study to gather preliminary data on a vestibular rehabilitation program. All participants who visit UHN memory clinic with a diagnosis of mild/moderate cognitive impairment due to Alzheimer's or vascular disease or both and have had falls will be asked to participate. If agree to be contacted they will receive a consent form.
All agreeable participants shall be screened for vestibular impairment through the following tests: Dix-Hall pike test, Head Impulse Test, Head Shake test, test of Dynamic Visual Acuity. In addition, participants will complete the MoCA to assess cognitive functioning. A score lower than 15 will exclude the participant.
After determining the population who is eligible for this study and willing to participate, participants shall move to baseline assessment. At baseline, measurements of balance, gait, and dynamic visual acuity in addition to questionnaires about dizziness felt, confidence in performing activities without falling, depression and quality of life, shall be completed.
Immediately after baseline, participants will begin their treatment arm, depending on if they have been put in the vestibular group or control group. Participants in the vestibular arm will be taught vestibular exercises and asked to perform vestibular exercises for 3 sessions daily, 3-10 minutes/session. Participation in vestibular exercises shall be recorded via a log by their caregiver. During the 12 weeks, these diaries shall be kept with the participant caregiver. Caregivers shall be followed up bi-weekly to ensure that participants are completing the exercises, and logging their participation.
At the end of the 12 weeks, participants will be reassessed with the same measures from baseline in addition to the head impulse test and test of dynamic visual acuity. The investigators shall also administer a final questionnaire (Problematic Experiences of Therapy Scale) to see what may have prevented completion of therapy or caused issues.
Participants that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.
3-months after final assessments (6 months after start), all participants shall be contacted to see if there were any falls/near fall experiences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Training (Intervention Group) | Experimental | Behavioral: Vestibular Training (Intervention Group)For the actual intervention, participants will be asked to commit a total of approximately 20 minutes a day of vestibular exercise, divided into three separate sessions (i.e. three 7 minute sessions). These will include eye movement exercises, walking and balancing. Every 2 weeks, there will be a slight change to the exercises to increase difficulty. (i.e. balancing on one leg or walking with head turns) |
| Usual Care (Control group) | No intervention | –Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Elderly people ages 65 and older
- English speaking
- Can log their participation or have a caregiver log on their behalf
- Mild/moderate dementia [(1) Alzheimer's disease, (2) small vessel vascular dementia not related to stroke and (3) mixed dementia of Alzheimer's or small vessel vascular not related to stroke] or mild/moderate cognitive impairment
- Vestibular Impairment
Key exclusion criteria (7 listed)
- Neurological disease (e.g. seizures, stroke, hemorrhage, central nervous system tumor, multiple sclerosis)
- Being diagnosed with a psychiatric disorder (e.g. Major depression episode, post-traumatic stress disorder, generalized anxiety disorder, schizophrenia, bipolar disorder etc.)
- Those with a current inner ear infection
- Those with severe neck arthritis
- Those with Post-Concussion Syndrome
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 |
|---|---|---|
| Vestibular Training (Intervention Group)Exercises three times daily, for up to approximately 20 minutes. Changes in functional status and physical status shall be measured at study onset and follow up. | Behavioural | Vestibular Training (Intervention Group) |
Primary outcome
Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
Time frame: 3 months and again 6 months after baseline
Measured by comparing the test score change from baseline to follow up at 3 months and again at 6 months to determine if the therapy worked
25 secondary outcomes
Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)
Time frame: 3 months
Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)
Time frame: 3 months
Change in quality of life through The Geriatric Depression Scale (GDS)
Time frame: 3 months
Cognitive status through the Montreal Cognitive Assessment (MoCA)
Time frame: 3 months
Change in physical functioning through the head impulse test (HIT)
Time frame: 3 months
Number of patients who can successfully complete Head Impulse Test (HIT)
Time frame: 3 months
Number of patients who can successfully complete Head Shake Test (HST)
Time frame: 3 months
Number of patients who can successfully complete Dynamic Gait Index (DGI)
Time frame: 3 months
Number of patients who can successfully complete the test of dynamic visual acuity (DVA)
Time frame: 3 months
Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Quality of Life in Alzheimer's Disease (QOL-AD)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Activities Specific Balance Confidence scale (ABC)
Time frame: 3 months
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)
Time frame: 3 months
Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)
Time frame: 3 months
Attrition Rate
Time frame: 3 months
Number of patients willing to participate
Time frame: 3 months
Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Time frame: 3 months
Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)
Time frame: 3 months
Change in physical functioning through the head shake test (HST)
Time frame: 3 months
Change in physical functioning through the dynamic visual acuity (DVA)
Time frame: 3 months
Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)
Time frame: 3 months
Change in physical functioning through the dynamic gait index (DGI)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Maria C Tartaglia, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Training (Intervention Group) in people with Alzheimer Dementia (AD) and Vascular Dementia, run by University Health Network, Toronto at 1 site in Canada.
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 7 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 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ) (time frame: 3 months and again 6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Oct 2018.