Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000963022
Ethics application status
Approved
Date submitted
5/11/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of treadmill inclination on the gait of children with Down's syndrome: a quasi-experimental study
Scientific title
Effect of treadmill inclination on angular alterations, amplitude of hip and knee movement, and stance time of gait in individuals with Down's syndrome
Secondary ID [1] 253031 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Down's syndrome 258590 0
Gait 258596 0
Condition category
Condition code
Neurological 258729 258729 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 258740 258740 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall duration of study was 6 months.The subjects were assessed for motor function and classified at level 1 of the Gross Motor Function Classification System (GMFCS), were evaluated. A subjective assessment of balance was performed using a questionnaire (Berg`s Balance Scale-BBS). Spatial-temporal variables of the lower limbs were observed as well as the angular variation of the hip, knee and ankle in the sagittal plane while the individuals walked on the treadmill at two different inclinations (0% and 10%) during 2 minutes in each condition. The treadmill was then turned on and the participants walked at a comfortable speed. After two minutes, a 30-second capture was made (dynamic collection). All the individuals were submitted to collections on the treadmill with inclinations of 0% and 10%. A one-minute rest period was given between the different conditions. The overall duration of the treadmill session was of approximately 6 minutes.
Intervention code [1] 257557 0
Not applicable
Comparator / control treatment
Spatial-temporal variables were observed as well as the angular variation of the hip, knee and ankle in the sagittal plane while the individuals walked on the treadmill at two different inclinations (0% and 10%).
Control group
Active

Outcomes
Primary outcome [1] 259596 0
Comparing of variables between 0% and 10% of inclination as measured by digitised video analysis showed that the stance time increased 4,8%.
In the hip, flexion at initial contact increased 13%, flexion at swing increased 10,2%, there was a decrease of 13% in maximum extension during terminal stance.
Timepoint [1] 259596 0
After two minutes in 0% of inclination
Secondary outcome [1] 266229 0
Comparing of variables between 0% and 10% of inclination as measured by digitised video analysis showed that the stance time increased 6%.
In the hip, flexion at initial contact increased 29,7%, flexion at swing increased 25,2%. There was a decrease of 25,2% in maximum extension during terminal stance. An increase of 8,7% was also observed in range of motion in the hip.
In the knee, flexion at initial contact increased 30%, maximum stance flexion increased 21,4%, range of motion increased 5,8%. In the ankle, there was decrease of 67,7% in the plantar flexed.
Timepoint [1] 266229 0
After two minutes in 10% of inclination

Eligibility
Key inclusion criteria
Children classified at level 1 of the Gross Motor Function Classification System – GMFCS; able to perform all the activities contained on the Berg Balance Scale (BBS); did not exhibit any other neurological alterations, or associated respiratory or osteomyoarticular pathologies; and exhibited good cognition that would allow completion of all the assessment procedures.
Minimum age
5 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals whose not understanding the instructions or for not collaborating during data collection.

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)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment outside Australia
Country [1] 3018 0
Brazil
State/province [1] 3018 0
Rio Grande do Norte

Funding & Sponsors
Funding source category [1] 258008 0
Government body
Name [1] 258008 0
Coordenacao de Aperfeicoamento de Pessoal de Nivel Superior
Country [1] 258008 0
Brazil
Primary sponsor type
University
Name
Universidade Federal do Rio Grande do Norte
Address
Av. Senador Salgado Filho, 3000
Caixa Postal 1524
Natal - RN
CEP 59072-970
Country
Brazil
Secondary sponsor category [1] 257201 0
None
Name [1] 257201 0
Address [1] 257201 0
Country [1] 257201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260003 0
Comite de Etica em Pesquisa do Hospital Universitario Onofre Lopes
Ethics committee address [1] 260003 0
Ethics committee country [1] 260003 0
Brazil
Date submitted for ethics approval [1] 260003 0
Approval date [1] 260003 0
12/08/2009
Ethics approval number [1] 260003 0
194/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31875 0
Address 31875 0
Country 31875 0
Phone 31875 0
Fax 31875 0
Email 31875 0
Contact person for public queries
Name 15122 0
Ana Raquel Rodrigues Lindquist
Address 15122 0
Universidade Federal do Rio Grande do Norte
Centro de Ciencias da Saude
Departamento de Fisioterapia
Av. Senador Salgado Filho, 3000
Caixa Postal 1524
Natal - RN
CEP 59072-970
Country 15122 0
Brazil
Phone 15122 0
55 84 3342 2010
Fax 15122 0
55 84 3342 2000
Email 15122 0
[email protected]
Contact person for scientific queries
Name 6050 0
Thayse de Lucena Moura Rodenbusch
Address 6050 0
Rua Fernando Barbosa de Melo, 400- Edifício Villa Real- APTO 102.
Catole
Campina Grande - PB
CEP 58410-440
Country 6050 0
Brazil
Phone 6050 0
55 83 3332 0000
Fax 6050 0
Email 6050 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.