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Fall Prevention - Vestibular Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03221296
Recruitment Status : Completed
First Posted : July 18, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Carmela Tartaglia, University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Alzheimer Dementia (AD) Vascular Dementia Behavioral: Vestibular Training (Intervention Group) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
Actual Study Start Date : June 27, 2017
Actual Primary Completion Date : August 23, 2018
Actual Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: 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)

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.

No Intervention: Usual Care (Control group)
Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03221296


Locations
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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Maria C Tartaglia, MD, FRCPC University Health Network, Toronto
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Responsible Party: Carmela Tartaglia, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03221296    
Other Study ID Numbers: 17-5055
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases