Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000810213
Ethics application status
Approved
Date submitted
15/09/2009
Date registered
17/09/2009
Date last updated
17/09/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hippotherapy and cycling in children with cerebral palsy
Scientific title
The hippotherapy associated with stationary cycling: effectiveness in gross motor function in cerebral palsied children
Secondary ID [1] 1099 0
Nil
Universal Trial Number (UTN)
U1111-1111-8341
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 243844 0
Condition category
Condition code
Neurological 240018 240018 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 240019 240019 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hippotherapy practice, (kind of therapy that uses the horse's movement to improve the motor control and to provide carefully graded sensory input) 10 times, once a week for a total of 10 weeks, during 30 minutes
Stationary cycling 10 times, once a week for a total of 10 weeks, during 10 minutes
Intervention code [1] 241277 0
Rehabilitation
Comparator / control treatment
Active control, one child practiced hippotherapy (10 times, once a week for a total of 10 weeks, during 30 minutes), another one practiced stationary cycling (10 times, once a week for a total of 10 weeks, during 10 minutes), and the third practice both hippotherapy and stationary cycling, with the same parameters for frequency, duration and time.
Control group
Active

Outcomes
Primary outcome [1] 240914 0
GMFM (Gross Motor Function Measure) in D and E dimensions
Timepoint [1] 240914 0
at baseline and at 10 weeks after commencement of the intervention
Secondary outcome [1] 257626 0
Optimal passive angle of lower limb joints measured by goniometry.
Timepoint [1] 257626 0
at baseline and at 10 weeks after commencement of the intervention
Secondary outcome [2] 257627 0
Spasticity for iliopsoas muscle, quadriceps muscle, adductors muscle,gastrocnemius muscle and soleus muscle, measured by Ashworth scale
Timepoint [2] 257627 0
at baseline and at 10 weeks after commencement of the intervention

Eligibility
Key inclusion criteria
Cerebral palsy diagnosis, diplegia type, capacity to understand simple commands, can walk with or without assistance, classified in Gross Motor Function Classification System (GMFCS) I or II.
Minimum age
5 Years
Maximum age
10 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No orthopaedic surgery, no botox, cannot understand simple commands

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3
Accrual to date
Final
Recruitment outside Australia
Country [1] 2141 0
Brazil
State/province [1] 2141 0
Rio de Janeiro

Funding & Sponsors
Funding source category [1] 243739 0
University
Name [1] 243739 0
Castelo Branco University
Country [1] 243739 0
Brazil
Primary sponsor type
Individual
Name
Ana Cecilia Del Duca Frazao
Address
Av. Pasteur 493, apt 04, Urca - Rio de Janeiro / CEP 22290240
Country
Brazil
Secondary sponsor category [1] 237100 0
Other Collaborative groups
Name [1] 237100 0
Center of Hippotherapy and Reabilitation in Military Village (CERVIM)
Address [1] 237100 0
Avenida Brasil, 27.195, Vila Militar, Deodoro - Rio de Janeiro- RJ / CEP 21615333
Country [1] 237100 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243863 0
Ethics committee in Research of Castelo Branco University
Ethics committee address [1] 243863 0
Ethics committee country [1] 243863 0
Brazil
Date submitted for ethics approval [1] 243863 0
Approval date [1] 243863 0
26/03/2009
Ethics approval number [1] 243863 0
0031/2009

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

Contacts
Principal investigator
Name 30287 0
Address 30287 0
Country 30287 0
Phone 30287 0
Fax 30287 0
Email 30287 0
Contact person for public queries
Name 13534 0
Ana Cecilia Del Duca Frazao
Address 13534 0
Av. Pasteur 493, apt 04, Urca, Rio de Janeiro - RJ CEP: 22290240
Country 13534 0
Brazil
Phone 13534 0
55 21 99730033
Fax 13534 0
55 21 24574791
Email 13534 0
[email protected]
Contact person for scientific queries
Name 4462 0
Ana Cecilia Del Duca Frazao
Address 4462 0
Av. Pasteur 493, apt 04, Urca, Rio de Janeiro - RJ CEP: 22290240
Country 4462 0
Brazil
Phone 4462 0
55 21 99730033
Fax 4462 0
55 21 24574791
Email 4462 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.