Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000018011
Ethics application status
Approved
Date submitted
6/01/2010
Date registered
7/01/2010
Date last updated
1/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of vestibular rehabilitation on functional capacity and balance in elderly patients with chronic dizziness
Scientific title
Effects of two protocols of vestibular rehabilitation on functional capacity and balance in elderly patients with chronic dizziness from vestibular disorders
Secondary ID [1] 1234 0
Nil
Universal Trial Number (UTN)
U1111-1113-1475
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dizziness from vestibular disorders 256475 0
Condition category
Condition code
Ear 256657 256657 0 0
Other ear disorders
Physical Medicine / Rehabilitation 256658 256658 0 0
Physiotherapy
Neurological 256659 256659 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vestibular Rehabilitation by the standard protocol of Cawthorne and Cooksey or by the Protocol of Cawthorne and Cooksey modified (multicomponents). The standard protocol of Cawthorne and Cooksey consists of eye, cephalic and trunk exercises, in order to stabilize the gaze, reduce dizziness and improve the postural control. This protocol was based on articles: Cawthorne T. The physiological basis for head exercises. J Chart Soc Physiother. 1944;29:106-7 and Cooksey FS. Rehabilitation in vestibular injuries. Proc Roy Soc Med. 1946; 39:273–278. The Cawthorne and Cooksey modified protocol contains the same exercises of the standard protocol with others components (flexibility, cognitive, sensory interaction and strength). Vestibular Rehabilitation protocols will be held at the Neurotology clinic, taught by trained physical therapist in individual sessions twice a week with 50 minutes, for two months (total 16 sessions)
Intervention code [1] 255760 0
Rehabilitation
Intervention code [2] 255775 0
Treatment: Other
Comparator / control treatment
Active control- treatment with the standard protocol
Control group
Active

Outcomes
Primary outcome [1] 257537 0
Functional capacity: Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily Living Scale.
Timepoint [1] 257537 0
At baseline, after 2 months of intervention and 3 months follow-up.
Primary outcome [2] 257538 0
Balance Control: Time up and Go (normal, motor and cognitive), Dynamic Gait Index, Multifuncitonal Reach, Static Test (Romberg eyes open and closed/ Tandem position with eyes opes and closed/ Unipedal stance with eyes open and closed).
Timepoint [2] 257538 0
At baseline, after 2 months of intervention and 3 months follow-up.
Secondary outcome [1] 262773 0
Cognition: Mini Mental State Exam
Timepoint [1] 262773 0
At baseline and after 2 months
Secondary outcome [2] 262774 0
Depression: Geriatric Depression Scale
Timepoint [2] 262774 0
At baseline, after 2 months of intervention and 3 months follow-up.
Secondary outcome [3] 262776 0
Symptons of dizziness: Visual Analogue Scale
Timepoint [3] 262776 0
At baseline, after 2 months of intervention and 3 months follow-up.

Eligibility
Key inclusion criteria
The inclusion criteria are: age and over 65 years, both genders and clinical diagnosis of chronic dizziness due to vestibular disorders. This clinical diagnosis is given when there is failure in the compensation of dizziness for 2 months or more after the triggering event.
Minimum age
65 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Will be excluded elderly patients with dizziness of no vestibular origin, cognitive deficit (reference values for the education of the Mini-Mental State Examination), locomotion with a walker and wheelchair, practicing regular physical activity, which performed rehabilitation of balance disorders in the past six months and use of drugs with action on the vestibular system. Elderly with Positional Benign Paroxysmal Vertigo (BPPV) are also excluded, since the intervention protocol does not address the repositioning maneuvers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by phone /fax /computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2010
Actual
15/04/2010
Date of last participant enrolment
Anticipated
Actual
15/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 2387 0
Brazil
State/province [1] 2387 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 256245 0
Charities/Societies/Foundations
Name [1] 256245 0
Universidade Federal de Sao Paulo
Country [1] 256245 0
Brazil
Funding source category [2] 285515 0
Charities/Societies/Foundations
Name [2] 285515 0
S?o Paulo Research Foundation (FAPESP)
Country [2] 285515 0
Brazil
Primary sponsor type
Individual
Name
Natalia Aquaroni Ricci
Address
Rua Afonso celso, 982 ap 12
Zip Code 04119-060
Sao Paulo- SP
Country
Brazil
Secondary sponsor category [1] 251576 0
Individual
Name [1] 251576 0
Mayra Cristina Aratani
Address [1] 251576 0
Rua Sergio Meira 230 ap.14 torre 3
Barra Funda
Zip Code: 01153-010
Sao Paulo
Country [1] 251576 0
Brazil
Other collaborator category [1] 1018 0
Individual
Name [1] 1018 0
Fernando Freitas Gananca
Address [1] 1018 0
Rua Periquito, 210/ 32a
Zip Code:04514-050
Sao Paulo
Country [1] 1018 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258339 0
Comite de Etica em Pesquisa da Universidade Federal de Sao Paulo/Hospital Sao Paulo
Ethics committee address [1] 258339 0
Ethics committee country [1] 258339 0
Brazil
Date submitted for ethics approval [1] 258339 0
14/10/2009
Approval date [1] 258339 0
30/10/2009
Ethics approval number [1] 258339 0
1/09/1656

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30664 0
Dr Natalia Aquaroni Ricci
Address 30664 0
Rua Afonso Celso, 982 apto 12 Zip Code: 04119-060 Sao Paulo- SP - Brazil
Country 30664 0
Brazil
Phone 30664 0
+55 11 25286484
Fax 30664 0
Email 30664 0
[email protected]
Contact person for public queries
Name 13911 0
Natalia Aquaroni Ricci
Address 13911 0
Rua Afonso Celso, 982 apto 12 Zip Code: 04119-060
São Paulo- SP - Brazil
Country 13911 0
Brazil
Phone 13911 0
+ 55 11 25286484
Fax 13911 0
Email 13911 0
[email protected]
Contact person for scientific queries
Name 4839 0
Fernando Freitas Gananca
Address 4839 0
Rua Periquito, 210/ 32aA
Zip Code:04514-050
Sao Paulo
Country 4839 0
Brazil
Phone 4839 0
+ 55 11 5044-2979
Fax 4839 0
Email 4839 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBenefits of vestibular rehabilitation on patient-reported outcomes in older adults with vestibular disorders: a randomized clinical trial.2020https://dx.doi.org/10.1016/j.bjpt.2019.12.003
N.B. These documents automatically identified may not have been verified by the study sponsor.