Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000086369
Ethics application status
Approved
Date submitted
12/02/2008
Date registered
14/02/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Handedness influences passive shoulder range of motion in adult women
Scientific title
Handedness influences passive shoulder range of motion in adult women as assessed by goniometry
Secondary ID [1] 520 0
none
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Range of motion 2815 0
Condition category
Condition code
Musculoskeletal 2951 2951 0 0
Normal musculoskeletal and cartilage development and function
Physical Medicine / Rehabilitation 2952 2952 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Shoulder flexion, abduction, horizontal adduction, extension, external and internal rotation were passively and bilaterally measured with a universal goniometer twice for each subject by the same examiner. Duration of measurements was 30 minutes.
Intervention code [1] 2552 0
Not applicable
Comparator / control treatment
no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3832 0
passive shoulder range of motion assessed by goniometry
Timepoint [1] 3832 0
at baseline and and at 2 weeks after baseline
Secondary outcome [1] 6460 0
none
Timepoint [1] 6460 0
none

Eligibility
Key inclusion criteria
white female students, ranging from 20 and 29 years of age, with normal Bone Mass Index (BMI) (20 < BMI < 24, 9) according to the World Health Organization (1995) and used the right arm as the dominant one, defined as the arm used to write and to predominantly perform their daily activities.
Minimum age
20 Years
Maximum age
29 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
hyper-mobility, previous surgery, trauma or injury involving any joint of either of the upper extremities, painful range of motion and pregnancy. Instrumental musicians, dancers and subjects who used their upper extremities in repetitive activities – like overhead sports involving repeated, preferentially unilateral, forceful arm actions – were also excluded from the study.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 786 0
Brazil
State/province [1] 786 0
Sao Paulo, Sao Paulo

Funding & Sponsors
Funding source category [1] 3078 0
Government body
Name [1] 3078 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 3078 0
Brazil
Primary sponsor type
Individual
Name
Ana Lucia Frangiotti Conte
Address
Rua Doutor Cesario Mota Junior, 476, apartamento 1205 Bloco B, CEP: 01221-020, Vila Buarque, Sao Paulo, SP
Country
Brazil
Secondary sponsor category [1] 2772 0
Individual
Name [1] 2772 0
Silvia Maria Amado Joao
Address [1] 2772 0
Rua Cipotanea, 51, Cidade Universitaria, CEP: 05360-160, Sao Paulo, SP
Country [1] 2772 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5026 0
Comissao de Etica para Analise de Projetos de Pesquisa CAPPesq da Diretoria Clinica do Hospital das Clinicas e da Faculdade de Medicina da Universidade de Sao Paulo
Ethics committee address [1] 5026 0
Av. Dr. Eneas de Carvalho Aguiar, 255, Cerqueira Cesar, CEP: 05403-000, Sao Paulo, SP
Ethics committee country [1] 5026 0
Brazil
Date submitted for ethics approval [1] 5026 0
26/08/2005
Approval date [1] 5026 0
27/10/2005
Ethics approval number [1] 5026 0
786/05

Summary
Brief summary
Goniometric measurement of range of motion is a widely used method in clinical practice, and has excellent reliability. During a rehabilitation of an injured shoulder, physiotherapists often use the contralateral joint as parameter to evaluate and estimate range of motion value. However, a conflicting question is if there is a dominance influence on shoulder range of motion. The purpose of this study is to determine whether there is a handedness influence on bilateral shoulder passive range of motion in healthy, non athlete adult women.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 28365 0
Address 28365 0
Country 28365 0
Phone 28365 0
Fax 28365 0
Email 28365 0
Contact person for public queries
Name 11522 0
Professor Dr. Silvia Maria Amado Joao
Address 11522 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional - Universidade de Sao Paulo
Rua Cipotanea, 51, Cidade Universitaria, CEP: 05360-160, Sao Paulo, SP
Country 11522 0
Brazil
Phone 11522 0
+ 55 11 30918424
Fax 11522 0
+ 55 11 30917462
Email 11522 0
smaj@usp.br
Contact person for scientific queries
Name 2450 0
Professor Dr. Silvia Maria Amado Joao
Address 2450 0
Departamento de Fisioterapia, Fonoaudiologia e Terapia Ocupacional - Universidade de Sao Paulo
Rua Cipotanea, 51, Cidade Universitaria, CEP: 05360-160, Sao Paulo, SP
Country 2450 0
Brazil
Phone 2450 0
+ 55 11 30918424
Fax 2450 0
+ 55 11 30917462
Email 2450 0
smaj@usp.br

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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