Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
NCT Number: NCT03221296
A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5T 2S8, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time frame: 3 months
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time frame: 3 months
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time frame: 3 months
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time frame: 3 months
Shall be measured by proportion of participants completing test (did not need to stop for any reason)
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
Shall be measured by percentage of test items completed
Time frame: 3 months
filled out by both, or either one of, the patient or caregiver
Time frame: 3 months
Will be measured as the percentage of those who reached follow-up compared to those who completed baseline
Time frame: 3 months
Determined by the proportion of patients saying yes out of those contacted
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
Time frame: 3 months
Measured by comparing the test score change from baseline to follow up at 3 months
University Health Network, Toronto
Other
A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
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