Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000517279
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
Ideal Treadmill Speed To Stimulate Walking Steps In Babies
Scientific title
Ideal Treadmill Speed To Stimulate Walking Steps In Babies
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Babies with typical development 237077 0
Condition category
Condition code
Physical Medicine / Rehabilitation 237397 237397 0 0
Physiotherapy
Musculoskeletal 237398 237398 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The infant was submitted a once time in four random belt speeds of the treadmill (0.1, 0.16, 0.22 e 0.28 m/s) during one minute each one, with passive reflective marcs in left shoulder, left hip, left knee, left ankle, and left fifth metatarsal to kinematics analysis, and filmed by a camera
Intervention code [1] 236797 0
Not applicable
Comparator / control treatment
there is no comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238198 0
descriptives variables of the foot step (cadence, step speed, step duration and step length)
Timepoint [1] 238198 0
film analyses of the four ten attempts (software Ariel Performance Analyses System - APAS), once only at end of intervention
Primary outcome [2] 238199 0
temporal variables of foot step (stance, first double support, single support and second double support)
Timepoint [2] 238199 0
film analyses of the four ten attempts (software Ariel Performance Analyses System - APAS), once only at end of intervention
Primary outcome [3] 238200 0
coordinatives variables of foot step (interlimb coordination)
Timepoint [3] 238200 0
film analyses of the four ten attempts (software Ariel Performance Analyses System - APAS), once only at end of intervention
Primary outcome [4] 238201 0
temporal series of joint angles (ankle, knee and hip)
Timepoint [4] 238201 0
film analyses of the four ten attempts (software Ariel Performance Analyses System - APAS), once only at end of intervention
Secondary outcome [1] 244505 0
nil
Timepoint [1] 244505 0
nil

Eligibility
Key inclusion criteria
health babies, previous to walking onset (cruising)
Minimum age
11 Months
Maximum age
13 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
neurological abnormalities

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 1849 0
Brazil
State/province [1] 1849 0
Rio Claro, SP

Funding & Sponsors
Funding source category [1] 237192 0
Charities/Societies/Foundations
Name [1] 237192 0
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo
Country [1] 237192 0
Brazil
Primary sponsor type
Individual
Name
Diana Xavier de Camargo Schlittler
Address
Av. 24 A, 1515, Rio Claro, SP
CEP: 13500-000
Universidade Estadual Paulista - UNESP
Country
Brazil
Secondary sponsor category [1] 4687 0
Individual
Name [1] 4687 0
Jose Angelo Barela
Address [1] 4687 0
Rua Galvao Bueno, 868 - Sao Paulo/SP
CEP:01506-000
Universidade Cruzeiro do Sul
Country [1] 4687 0
Brazil
Other collaborator category [1] 712 0
Individual
Name [1] 712 0
Raquel de Paula Carvalho
Address [1] 712 0
Universidade Federal de Sao Paulo.
Av. Saldanha da Gama, 89
Ponta da Praia
11030-400 - Santos, SP - Brasil
Country [1] 712 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239286 0
Comite de Etica em Pesquisa da Universidade Estadual Paulista - UNESP Campus de Rio Claro
Ethics committee address [1] 239286 0
Av. 24 A, 1515, CEP:13500-000
Rio Claro, SP
Ethics committee country [1] 239286 0
Brazil
Date submitted for ethics approval [1] 239286 0
11/07/2007
Approval date [1] 239286 0
11/09/2007
Ethics approval number [1] 239286 0
179/2007

Summary
Brief summary
purpose of the study: investigate the effects of different treadmill belt speeds on babies foot steps.
Hypothesys:
1. In the highest belt speeds, the foot steps look like mature gait in the kinematics parameters;
2. In the highest belt speeds, the descriptive, temporal and coordenatives variables of the babies foot steps look like the mature gait.
3. The highest belt speeds (0.22 and 0.28 m/s) are the best speeds to stimulate foot steps in babies in the treadmill
Trial website
Trial related presentations / publications
1.Congresso Internacional de Ciências do Movimento Humano, June 2008, Sao Paulo, SP, Brazil
2.IV Congresso Brasileiro de Comportamento Motor, July 2008, Sao Paulo, SP, Brazil
Public notes

Contacts
Principal investigator
Name 29784 0
Address 29784 0
Country 29784 0
Phone 29784 0
Fax 29784 0
Email 29784 0
Contact person for public queries
Name 13031 0
Diana Xavier de Camargo Schlittler
Address 13031 0
Rua 2, 3521, Rio Claro, SP
CEP: 13504-111
Country 13031 0
Brazil
Phone 13031 0
55 19 30240170
Fax 13031 0
Email 13031 0
[email protected]
Contact person for scientific queries
Name 3959 0
Jose Angelo Barela
Address 3959 0
Rua Galvao Bueno, 868
Sao Paulo - SP
CEP 01506-000
Country 3959 0
Brazil
Phone 3959 0
55 11 33853103
Fax 3959 0
Email 3959 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
SourceTitleYear of PublicationDOI
EmbaseIdeal treadmill speed to stimulate stepping in infants. [Portuguese]2010
N.B. These documents automatically identified may not have been verified by the study sponsor.