Fall Prevention - Vestibular Rehabilitation

Vascular Dementia Clinical Trial

Official title:

A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221296
• Other study ID #: 17-5055
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: August 23, 2018

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Dementia (AD)
• Alzheimer Disease
• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months and again 6 months after baseline
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	Cognitive status through the Montreal Cognitive Assessment (MoCA)	Measured by comparing the test score change from baseline to follow up at 3 months	3 months
Secondary	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	3 months
Secondary	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)	3 months
Secondary	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)	3 months
Secondary	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)	3 months
Secondary	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)	3 months
Secondary	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)	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	Attrition Rate	Will be measured as the percentage of those who reached follow-up compared to those who completed baseline	3 months
Secondary	Number of patients willing to participate	Determined by the proportion of patients saying yes out of those contacted	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	3 months