Trials / Completed
CompletedNCT03221296
Fall Prevention - Vestibular Rehabilitation
A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-06-27
- Primary completion
- 2018-08-23
- Completion
- 2018-08-23
- First posted
- 2017-07-18
- Last updated
- 2018-10-11
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT03221296. Inclusion in this directory is not an endorsement.