Fall Prevention - Vestibular Rehabilitation

NCT03221296 | Completed

• 1 other identifier: 17-5055
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Dementia (AD); Vascular Dementia

Outcome Measures

Primary Outcomes (1)

• Number of falls/near fall experiences through the Falls Video Analysis Questionnaire (FVAQ)

  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

  3 months and again 6 months after baseline

Secondary Outcomes (25)

• 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

• Cognitive status through the Montreal Cognitive Assessment (MoCA)

  3 months

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

  3 months

Study Arms (2)

Vestibular Training (Intervention Group)

EXPERIMENTAL

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)

Usual Care (Control group)

NO INTERVENTION

Patients that are randomized to standard of care Control group will undergo Baseline and 12-week assessments including vestibular testing and questionnaires.

Interventions

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.

Vestibular Training (Intervention Group)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia, Vascular

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maria C Tartaglia, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 18, 2017
• Study Start: June 27, 2017
• Primary Completion: August 23, 2018
• Study Completion: August 23, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)