A Feasibility Study on the Effects of Vestibular Training as a Fall Prevention Strategy in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
研究概览
简要总结
A feasibility study of a vestibular rehabilitation program in a sample of cognitively impaired clinical patients to guide future trials.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Vestibular Training (Intervention Group) (Behavioral)
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.
结局指标
主要结局
Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)
时间窗: 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
次要结局
- Number of patients who can successfully complete Head Impulse Test (HIT)(3 months)
- Change in physical functioning through the dynamic gait index (DGI)(3 months)
- Change in levels of dizziness through the Dizziness Handicap Inventory (DHI)(3 months)
- Change in perceived level of confidence through the Activities Specific Balance Confidence Scale (ABC)(3 months)
- Change in quality of life through The Geriatric Depression Scale (GDS)(3 months)
- Change in physical functioning through the head impulse test (HIT)(3 months)
- Cognitive status through the Montreal Cognitive Assessment (MoCA)(3 months)
- Number of patients who can successfully complete Head Shake Test (HST)(3 months)
- Number of patients who can successfully complete Dynamic Gait Index (DGI)(3 months)
- Number of patients who can successfully complete the test of dynamic visual acuity (DVA)(3 months)
- Number of patients who can successfully complete the modified clinical test of sensory interaction on balance (mCTSIB)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Dizziness Handicap Inventory (DHI)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Montreal Cognitive Assessment (MoCA)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Quality of Life in Alzheimer's Disease (QOL-AD)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the World Health Organization Quality of Life - BREF (WHOQOL-BREF)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Activities Specific Balance Confidence scale (ABC)(3 months)
- Completeness of questionnaires and which questions were: skipped, missed or difficult to understand for the Geriatric Depression Scale (GDS)(3 months)
- Number of patients who successfully adhered to the vestibular rehabilitation program through the Problematic Experiences of Therapy scale (PETs)(3 months)
- Attrition Rate(3 months)
- Number of patients willing to participate(3 months)
- Change in quality of life through The World Health Organization Quality of Life - BREF (WHOQOL-BREF)(3 months)
- Change in quality of life through The Quality of Life in Alzheimer's Disease (QOL-AD)(3 months)
- Change in physical functioning through the head shake test (HST)(3 months)
- Change in physical functioning through the dynamic visual acuity (DVA)(3 months)
- Change in physical functioning through the modified clinical test of sensory interaction on balance (mCTSIB)(3 months)
研究者
Carmela Tartaglia
Principal Investigator
University Health Network, Toronto