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Trial registered on ANZCTR


Registration number
ACTRN12609000518268
Ethics application status
Approved
Date submitted
23/06/2009
Date registered
30/06/2009
Date last updated
30/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Verify the effect of the treadmill intervention on the motor development of high risk babies
Scientific title
Verify the effect of the treadmill intervention on the motor development of high risk babies
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
motor development in high risk babies 237078 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237399 237399 0 0
Physiotherapy
Musculoskeletal 237400 237400 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treadmill intervention twice times a week, belt speed 0.28 m/s, 8 minutes a day, until babies are able to walk independently, after physical therapy session of precocial stimulation of motor development that consists of sensory-motor stimulation by 45 minutes also twice times a week, until babies are able to walk independently.
Intervention code [1] 236798 0
Rehabilitation
Comparator / control treatment
High Risk Babies Group without treadmill intervention
Control group
Active

Outcomes
Primary outcome [1] 238202 0
age of walking onset
Timepoint [1] 238202 0
assessed during interventions months by Alberta Infant Motor Scale - AIMS, since the first month of intervention until the age of walking independent onset
Primary outcome [2] 238203 0
type and quantity of babies steps in the treadmill film for 2 minutes during intervention sessions (alternate, parallel, single, double)
Timepoint [2] 238203 0
assessed during interventions months by film, since the first month of intervention until the age of walking independent onset
Secondary outcome [1] 244506 0
age of others milestones (roling, sit alone, crawling and standing alone)
Timepoint [1] 244506 0
assessed during interventions months by Alberta Infant Motor Scale - AIMS, since the first month of intervention until the age of walking independent onset

Eligibility
Key inclusion criteria
high risk babies (prematurity, low birth weight, sepsis, meningitis, resuscitation, high-frequency ventilation, total parenteral nutrition, prolonged oxygen requirements, intraventricular and periventricular hemorrhage levels I and II, seizures)
Minimum age
5 Months
Maximum age
14 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Abnormal neurologic exam at discharge, congenital abnormalities

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1850 0
Brazil
State/province [1] 1850 0
Rio Claro, SP

Funding & Sponsors
Funding source category [1] 237193 0
Charities/Societies/Foundations
Name [1] 237193 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Address [1] 237193 0
R. Pio XI, 1500 - Alto da Lapa - CEP 05468-901 - Sao Paulo/SP
Country [1] 237193 0
Brazil
Primary sponsor type
Individual
Name
Diana Xavier de Camargo Schlittler
Address
A. 24 A, 1515, CEP: 13500-000
Rio Claro, SP

Universidade Estadual Paulista
Country
Brazil
Secondary sponsor category [1] 4688 0
Individual
Name [1] 4688 0
Jose Angelo Barela
Address [1] 4688 0
Rua Galvao Bueno, 868 - Sao Paulo/SP
CEP: 01506-000

Universidade Cruzeiro do Sul
Country [1] 4688 0
Brazil
Other collaborator category [1] 713 0
Individual
Name [1] 713 0
Raquel de Paula Carvalho
Address [1] 713 0
Universidade Federal de Sao Paulo.
Av. Saldanha da Gama, 89
Ponta da Praia
11030-400 - Santos, SP
Country [1] 713 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239287 0
Comite de Etica em Pesquisa da Universidade Estadual Paulista - UNESP Campus de Rio Claro
Ethics committee address [1] 239287 0
Av. 24 A, 1515, Rio Claro, SP, CEP: 13500-000
Ethics committee country [1] 239287 0
Brazil
Date submitted for ethics approval [1] 239287 0
11/07/2007
Approval date [1] 239287 0
11/09/2007
Ethics approval number [1] 239287 0
179/2007

Summary
Brief summary
Purpose: Investigate the effects of treadmill interventions in high risk babies motor development
Hypothesis:
1. The experimental group will acquire the independent walking earlier than the high risk babies control group
2. The experimental group will acquire the others milestones earlier than the high risk babies control group
3. The alternative steps will increase along the intervention months
Trial website
Trial related presentations / publications
1. I Encontro Paulista de Comportamento Motor, May 2009, Sao Paulo, SP, Brazil
2. XX Congresso Nacional da ABENEPI, June 2009, Campinas, SP, Brazil
Public notes

Contacts
Principal investigator
Name 29785 0
Address 29785 0
Country 29785 0
Phone 29785 0
Fax 29785 0
Email 29785 0
Contact person for public queries
Name 13032 0
Diana Xavier de Camargo Schlittler
Address 13032 0
Rua 2, 3521, Rio Claro, SP
CEP: 13504-111
Country 13032 0
Brazil
Phone 13032 0
55 19 30240170
Fax 13032 0
Email 13032 0
diana_xcs@yahoo.com.br
Contact person for scientific queries
Name 3960 0
Jose Angelo Barela
Address 3960 0
Rua Galvao Bueno, 868, Sao Paulo, SP
CEP: 01506-000
Country 3960 0
Brazil
Phone 3960 0
55 11 33853103
Fax 3960 0
Email 3960 0
jose.barela@cruzeirodosul.edu.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary