Clinical trial NCT03221296: Fall Prevention - Vestibular Rehabilitation
Official title: A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Dementia (AD)
Vascular Dementia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 29
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
timeFrame: 3 months and again 6 months after baseline
Secondary outcomes:
measure: Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)
timeFrame: 3 months
measure: Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)
timeFrame: 3 months
measure: Change in quality of life through The Geriatric Depression Scale (GDS)
timeFrame: 3 months
measure: Cognitive status through the Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months
measure: Change in physical functioning through the head impulse test (HIT)
timeFrame: 3 months
measure: Number of patients who can successfully complete Head Impulse Test (HIT)
timeFrame: 3 months
measure: Number of patients who can successfully complete Head Shake Test (HST)
timeFrame: 3 months
measure: Number of patients who can successfully complete Dynamic Gait Index (DGI)
timeFrame: 3 months
measure: Number of patients who can successfully complete the test of dynamic visual acuity (DVA)
timeFrame: 3 months
measure: Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Quality of Life in Alzheimer's Disease (QOL-AD)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Activities Specific Balance Confidence scale (ABC)
timeFrame: 3 months
measure: Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)
timeFrame: 3 months
measure: Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)
timeFrame: 3 months
measure: Attrition Rate
timeFrame: 3 months
measure: Number of patients willing to participate
timeFrame: 3 months
measure: Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: 3 months
measure: Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)
timeFrame: 3 months
measure: Change in physical functioning through the head shake test (HST)
timeFrame: 3 months
measure: Change in physical functioning through the dynamic visual acuity (DVA)
timeFrame: 3 months
measure: Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)
timeFrame: 3 months
measure: Change in physical functioning through the dynamic gait index (DGI)
timeFrame: 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Maria C Tartaglia, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: