Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000039987
Ethics application status
Approved
Date submitted
8/01/2011
Date registered
12/01/2011
Date last updated
12/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vestibular rehabilitation in patients with benign paroxysmal positional vertigo
Scientific title
Study conducted with nine women with benign paroxysmal positional vertigo undergo a vestibular rehabilitation protocol obtaining improvement in the physical aspect by dizziness handicap inventory
Secondary ID [1] 253366 0
Ethics Committee of the Faculdade de Medicina de Rio Preto: 3141/2009 protocol.
Universal Trial Number (UTN)
U1111-1118-9143
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign paroxysmal positional vertigo 260900 0
Condition category
Condition code
Physical Medicine / Rehabilitation 259040 259040 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention implemented by undergraduate students of physiotherapy trained and supervised by a physiotherapist teacher applied in two sessions of 40 minutes with a one week break in between the two sessions: manual therapy that were applied in the cervical region consisted of manual traction of the neck , extending the bilateral upper trapezius, scalene, sternocleidomastoid and levator scapula and massage in the region of the upper trapezius and neck applied only to the Epley maneuver, which was performed according to the affected semicircular canal and is composed of a series of head movements to direct the particles into the utricle, and then recommendations were passed as sleeping or sitting with the trunk elevated 45 degrees, recliner, wedges, or use two pillows for 48 hours after the maneuver for seven days and avoid sudden movements and those that do not cause dizziness, no sleep on the affected ear, and looking up or down. It was based also required that patients had their daily activities, with great variability in head movement remain neck collar to prevent head movements.
Intervention code [1] 257805 0
Rehabilitation
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259890 0
Patients showed improvement in physical appearance in the short term with 15 points after the second session representing short-term improvement and 10 points after 6 months at long-term improvement, being that the closer to zero the better the effect of vestibular rehabilitation on the dizzy when assessed by the Dizziness Handicap Inventory (DHI)
Timepoint [1] 259890 0
After 02 sessions and six months after the second intervention
Primary outcome [2] 259891 0
Patients get scores in the emotional aspect maintained in the short term, with five points after the second session and after six months, and the closer to zero the better the effect of vestibular rehabilitation on the patients with benign paroxysmal positional vertigo when evaluated by Dizziness Handicap Inventory (DHI)
Timepoint [2] 259891 0
After 02 sessions and six months after the second intervention
Secondary outcome [1] 268777 0
The patients had scores in the emotional aspect in the short term, with eight points after the second session and 11 points after six months, and the closer to zero the better the effect of vestibular rehabilitation on the patients with benign paroxysmal positional vertigo when assessed by the Dizziness Handicap Inventory (DHI), demonstrated that the framework of the patients worsened in this respect
Timepoint [1] 268777 0
After 02 sessions and six months after the second intervention

Eligibility
Key inclusion criteria
submit to maneuver Dix-Hallpike positive. this is considered positive when triggered vertigo and nystagmus on changing position of the person from sitting to lying with his head held below the horizontal plane with a 45 degrees rotation of the head to the side to be tested, with latencies for four rotational nystagmus five seconds and lasting around thirty to forty seconds.
Minimum age
56 Years
Maximum age
73 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
excluded who reported no history of neurological disorders, infectious diseases, tumors, central vestibular disorders and psychiatric reports

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
9
Accrual to date
Final
Recruitment outside Australia
Country [1] 3131 0
Brazil
State/province [1] 3131 0
Sao paulo

Funding & Sponsors
Funding source category [1] 258282 0
University
Name [1] 258282 0
Centro universitario de rio preto
Country [1] 258282 0
Brazil
Primary sponsor type
Individual
Name
Joao Simao de Melo Neto
Address
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country
Brazil
Secondary sponsor category [1] 257446 0
Individual
Name [1] 257446 0
Ana Elisa Zuliani Stroppa
Address [1] 257446 0
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country [1] 257446 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260265 0
ethics committee on research of Faculdade de Medicina de Rio Preto
Ethics committee address [1] 260265 0
Ethics committee country [1] 260265 0
Brazil
Date submitted for ethics approval [1] 260265 0
15/06/2009
Approval date [1] 260265 0
14/07/2009
Ethics approval number [1] 260265 0
3141/2009

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

Contacts
Principal investigator
Name 32062 0
Address 32062 0
Country 32062 0
Phone 32062 0
Fax 32062 0
Email 32062 0
Contact person for public queries
Name 15309 0
Joao Simao de Melo Neto
Address 15309 0
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country 15309 0
Brazil
Phone 15309 0
+55 17 32116060
Fax 15309 0
Email 15309 0
[email protected]
Contact person for scientific queries
Name 6237 0
Joao Simao de Melo Neto
Address 6237 0
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country 6237 0
Brazil
Phone 6237 0
+55 17 32116060
Fax 6237 0
Email 6237 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
No additional documents have been identified.