Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000700235
Ethics application status
Approved
Date submitted
8/08/2009
Date registered
13/08/2009
Date last updated
13/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Applicability of the Timed up and go (TUG) and the Timed up and down stairs to children with cerebral palsy.
Scientific title
Applicability of the Timed up and go (TUG) and the Timed up and down stairs (TUDS) compared with the Gross Motor Function Measure (GMFM) to measure functional mobility in children with cerebral palsy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 243483 0
Condition category
Condition code
Physical Medicine / Rehabilitation 239783 239783 0 0
Physiotherapy
Neurological 239799 239799 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention was based on Neurodevelopmental principles. The protocol included 2 sessions per week for a total of 8 weeks. Each session lasted 1 hour and was supervised by a trained physiotherapist.
All the sessions started with stretching exercises and handles aimed at improving the child mobility. Then, the children performed voluntary exercises such as training on walking, going up and down stairs and standing up from sitting position. Increased demands such as high speed and load addition were provided according to the child conditions.
Intervention code [1] 237101 0
Rehabilitation
Comparator / control treatment
All participants were treated
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240551 0
Functional mobility in children with spastic cerebral palsy. Such an outcome will be assessed by using the Timed Up and go (TUG) test, the Timed up and down stairs (TUDS) test, and the Gross motor function measure (GMFM)
Timepoint [1] 240551 0
at baseline and 8 weeks after the intervention beggining.
Secondary outcome [1] 257132 0
Applicability of the Timed up and go (TUG) and Timed up and down stairs (TUDS), as complement to the Gross Motor Function Measure (GMFM)
Timepoint [1] 257132 0
at baseline and 8 weeks after the intervention beggining.

Eligibility
Key inclusion criteria
spastic cerebral palsy
levels I and II for Gross motor function classification system
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
surgeries in the last 6 months before the intervention

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)
A convenience sample was selected from children participating in physical therapy programs in Federal University of Sao Carlos - Brazil.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nonradomised
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
18/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 1938 0
Brazil
State/province [1] 1938 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 237471 0
Self funded/Unfunded
Name [1] 237471 0
Country [1] 237471 0
Brazil
Primary sponsor type
University
Name
Universidade Federal de Sao Carlos
Address
Rodovia Washington Luis km 235 CEP: 13565-605
Sao Carlos - SP - Brazil
Country
Brazil
Secondary sponsor category [1] 236958 0
None
Name [1] 236958 0
Address [1] 236958 0
Country [1] 236958 0
Other collaborator category [1] 813 0
Individual
Name [1] 813 0
Nelci Adriana Cicuto Ferreira Rocha
Address [1] 813 0
Rua Jose Riga 310 Residencial Samambaia
Sao Carlos - SP - Brazil
Country [1] 813 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239598 0
Comite de etica e pesquisa Universidade Federal de Sao Carlos
Ethics committee address [1] 239598 0
Rodovia Washington Luis km 235 CEP: 13565-905, Sao Carlos-SP - Brazil.
Ethics committee country [1] 239598 0
Brazil
Date submitted for ethics approval [1] 239598 0
Approval date [1] 239598 0
28/09/2004
Ethics approval number [1] 239598 0
1/04/0018

Summary
Brief summary
Background: Employing measurement tools which assess the refinement of motor skills in cerebral palsied children is relevant to physical therapists. Nevertheless, the applicability of functional mobility tests, namely the Timed up and go (TUG) and the Timed up and down stairs (TUDS) has not been investigated before. Objectives: To verify the applicability of TUG and TUDS, as well as of the Gross Motor Function Measure (GMFM) dimensions, in measurement of changes occurring in children with cerebral palsy after an intervention program. Methods: Six children with spastic cerebral palsy and classified by the Gross Motor Function Classification System as level I or II were enrolled in the study. They were assessed by using TUG, TUDS and GMFM before and after an 8-week intervention program based on neurodevelopmental principles. Results: TUG has detected that the time children spent during the task of standing from sitting position and walk was decreased after intervention, and TUDS has detected that the time children spent during the task of going up and down stairs was also decreased. GMFM detected changes at dimension D (standing) and E (walking, running and jumping). Conclusions: TUG and TUDS are applicable and effective tools which enable the measurement of changes in functional mobility after an intervention program in children with cerebral palsy. These tests are also shown to complement information provided by GMFM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30025 0
Address 30025 0
Country 30025 0
Phone 30025 0
Fax 30025 0
Email 30025 0
Contact person for public queries
Name 13272 0
Nelci Adriana Cicuto Ferreira Rocha
Address 13272 0
Rua Jose Riga 310 Residencial Samambaia Sao Carlos - SP - Brazil
Country 13272 0
Brazil
Phone 13272 0
+ 55 16 33518407
Fax 13272 0
Email 13272 0
[email protected]
Contact person for scientific queries
Name 4200 0
Nelci Adriana Cicuto Ferreira Rocha
Address 4200 0
Rua Jose Riga 310 Residencial Samambaia Sao Carlos - SP - Brazil
Country 4200 0
Brazil
Phone 4200 0
+ 55 16 33518407
Fax 4200 0
Email 4200 0
[email protected]

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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