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Fall Prevention - Vestibular Rehabilitation

Primary Purpose

Alzheimer Dementia (AD), Vascular Dementia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Vestibular Training (Intervention Group)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Dementia (AD)

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Vestibular Training (Intervention Group)

Usual Care (Control group)

Arm Description

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)

Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
Cognitive status through the Montreal Cognitive Assessment (MoCA)
Measured by comparing the test score change from baseline to follow up at 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
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
Attrition Rate
Will be measured as the percentage of those who reached follow-up compared to those who completed baseline
Number of patients willing to participate
Determined by the proportion of patients saying yes out of those contacted
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
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
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
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
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
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

Full Information

First Posted
July 7, 2017
Last Updated
October 10, 2018
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03221296
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Dementia (AD), Vascular Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Training (Intervention Group)
Arm Type
Experimental
Arm Description
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)
Arm Title
Usual Care (Control group)
Arm Type
No Intervention
Arm Description
Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Vestibular Training (Intervention Group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
Description
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
Time Frame
3 months and again 6 months after baseline
Secondary Outcome Measure Information:
Title
Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in quality of life through The Geriatric Depression Scale (GDS)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Cognitive status through the Montreal Cognitive Assessment (MoCA)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in physical functioning through the head impulse test (HIT)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Number of patients who can successfully complete Head Impulse Test (HIT)
Description
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time Frame
3 months
Title
Number of patients who can successfully complete Head Shake Test (HST)
Description
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time Frame
3 months
Title
Number of patients who can successfully complete Dynamic Gait Index (DGI)
Description
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time Frame
3 months
Title
Number of patients who can successfully complete the test of dynamic visual acuity (DVA)
Description
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time Frame
3 months
Title
Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)
Description
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Quality of Life in Alzheimer's Disease (QOL-AD)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Activities Specific Balance Confidence scale (ABC)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)
Description
Shall be measured by percentage of test items completed
Time Frame
3 months
Title
Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)
Description
filled out by both, or either one of, the patient or caregiver
Time Frame
3 months
Title
Attrition Rate
Description
Will be measured as the percentage of those who reached follow-up compared to those who completed baseline
Time Frame
3 months
Title
Number of patients willing to participate
Description
Determined by the proportion of patients saying yes out of those contacted
Time Frame
3 months
Title
Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in physical functioning through the head shake test (HST)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in physical functioning through the dynamic visual acuity (DVA)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months
Title
Change in physical functioning through the dynamic gait index (DGI)
Description
Measured by comparing the test score change from baseline to follow up at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria C Tartaglia, MD, FRCPC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Fall Prevention - Vestibular Rehabilitation

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