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Completed

NCT Number: NCT03221296

Fall Prevention - Vestibular Rehabilitation

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vestibular Training (Intervention Group)

Behavioral

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 outcomes

  1. 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

Secondary outcomes

  1. Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  2. Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  3. Change in quality of life through The Geriatric Depression Scale (GDS)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  4. Cognitive status through the Montreal Cognitive Assessment (MoCA)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  5. Change in physical functioning through the head impulse test (HIT)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  6. Number of patients who can successfully complete Head Impulse Test (HIT)

    Time frame: 3 months

    Shall be measured by proportion of participants completing test (did not need to stop for any reason)

  7. Number of patients who can successfully complete Head Shake Test (HST)

    Time frame: 3 months

    Shall be measured by proportion of participants completing test (did not need to stop for any reason)

  8. Number of patients who can successfully complete Dynamic Gait Index (DGI)

    Time frame: 3 months

    Shall be measured by proportion of participants completing test (did not need to stop for any reason)

  9. Number of patients who can successfully complete the test of dynamic visual acuity (DVA)

    Time frame: 3 months

    Shall be measured by proportion of participants completing test (did not need to stop for any reason)

  10. Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)

    Time frame: 3 months

    Shall be measured by proportion of participants completing test (did not need to stop for any reason)

  11. Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)

    Time frame: 3 months

    Shall be measured by percentage of test items completed

  12. Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)

    Time frame: 3 months

    Shall be measured by percentage of test items completed

  13. 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

    Shall be measured by percentage of test items completed

  14. 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

    Shall be measured by percentage of test items completed

  15. 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

    Shall be measured by percentage of test items completed

  16. Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)

    Time frame: 3 months

    Shall be measured by percentage of test items completed

  17. Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)

    Time frame: 3 months

    filled out by both, or either one of, the patient or caregiver

  18. Attrition Rate

    Time frame: 3 months

    Will be measured as the percentage of those who reached follow-up compared to those who completed baseline

  19. Number of patients willing to participate

    Time frame: 3 months

    Determined by the proportion of patients saying yes out of those contacted

  20. Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  21. Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  22. Change in physical functioning through the head shake test (HST)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  23. Change in physical functioning through the dynamic visual acuity (DVA)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  24. Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

  25. Change in physical functioning through the dynamic gait index (DGI)

    Time frame: 3 months

    Measured by comparing the test score change from baseline to follow up at 3 months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 18, 2017
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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