Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000386437
Ethics application status
Approved
Date submitted
23/07/2007
Date registered
23/07/2007
Date last updated
3/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Sensorimotor Training in patients with rheumatoid arthritis – a randomised controlled trial.
Scientific title
A randomised controlled trial to evaluate the effectiveness of Sensorimotor Training in patients with rheumatoid arthritis
Secondary ID [1] 259907 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 1968 0
Condition category
Condition code
Inflammatory and Immune System 2066 2066 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 2 times a week for 16 weeks, 50 patients per group.
2 Groups
Intervention group
Group 1: Perturbation training: balance training (feet together, semi and tandem position, one leg stance, and unstable platforms), coordination and agility training (gait speed, shuttle walk, tandem walk, crossover walk, side-to-side walk, and carioca)
Intervention code [1] 1904 0
Rehabilitation
Intervention code [2] 286174 0
Other interventions
Comparator / control treatment
Control Group:
Group 2: the Control group does not receive any intervention.
Assessed pre and immediately post 16 weeks.
Control group
Active

Outcomes
Primary outcome [1] 3150 0
Health Assessment Questionary (HAQ)
Timepoint [1] 3150 0
Assessed pre, 12 weeks, immediately post intervention (16 weeks) and 4 weeks post intervention.
Primary outcome [2] 3151 0
Timed up and go test
Timepoint [2] 3151 0
Assessed pre, 12 weeks, immediately post intervention (16 weeks) and 4 weeks post intervention.
Secondary outcome [1] 4893 0
Berg Balance Scale (BBS)
Timepoint [1] 4893 0
Assessed pre, 12 weeks,immediately post intervention (16 weeks) and 4 weeks post intervention.
Secondary outcome [2] 4894 0
Tinetti Test
Timepoint [2] 4894 0
Assessed pre, 12 weeks,immediately post intervention (16 weeks) and 4 weeks post intervention.
Secondary outcome [3] 4895 0
Short Form - 36
Timepoint [3] 4895 0
Assessed pre, 12 weeks,immediately post intervention (16 weeks) and 4 weeks post intervention.

Eligibility
Key inclusion criteria
Rheumatoid arthritis patients
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not controlled Arterial HypertensionNot controlled Diabetes MellitusOther rheumatic diseases, with exception for osteoarthritis.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the people assessing the outcomes (assessor) and the people analysing the results/data (data analyst) will be blinded
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
129
Accrual to date
Final
Recruitment outside Australia
Country [1] 531 0
Brazil
State/province [1] 531 0
S?o Paulo - SP

Funding & Sponsors
Funding source category [1] 2212 0
Hospital
Name [1] 2212 0
Ambulatory of Specialities of Grajau
Country [1] 2212 0
Brazil
Funding source category [2] 3137 0
University
Name [2] 3137 0
University Federeal of S?o Paulo - UNIFESP/EPM
Country [2] 3137 0
Brazil
Primary sponsor type
Individual
Name
Kelson Nonato Gomes da Silva
Address
146, Elísio de Carvalho Street - São Paulo-SP
Country
Brazil
Secondary sponsor category [1] 1995 0
Other Collaborative groups
Name [1] 1995 0
Virgínia Fernandes Moça Trevisani
Address [1] 1995 0
598, Pedro Toledo Street - São Paulo-SP
Country [1] 1995 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4048 0
Federal University of São Paulo
Ethics committee address [1] 4048 0
Ethics committee country [1] 4048 0
Brazil
Date submitted for ethics approval [1] 4048 0
Approval date [1] 4048 0
14/11/2006
Ethics approval number [1] 4048 0
CEP 1092/05

Summary
Brief summary
purpose of the study: verify the effectiveness of sensorimotor training in the improvement of the quality of life and functional capacity in patients with rheumatoid arthritis.
Hypothesis:
Sensorimotor training improves the quality of life and functional capacity in patients with rheumatoid arthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27718 0
Mr Kelson Nonato Gomes da Silva
Address 27718 0
1666, Leôncio Ferraz, Street
Country 27718 0
Brazil
Phone 27718 0
+55 086 88130553
Fax 27718 0
Email 27718 0
[email protected]
Contact person for public queries
Name 11093 0
Prof Kelson Nonato Gomes da Silva
Address 11093 0
Rua Pedro de Toledo 598
Country 11093 0
Brazil
Phone 11093 0
55 - 11 - 55752970
Fax 11093 0
Email 11093 0
[email protected]
Contact person for scientific queries
Name 2021 0
Mrs Maria Stella Peccin
Address 2021 0
Rua Pedro de Toledo 598
Country 2021 0
Brazil
Phone 2021 0
55 - 11 - 55752970
Fax 2021 0
Email 2021 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.