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
Av. de Santa Cruz, 1631 - Realengo, Rio de Janeiro - RJ, CEP 21710-255O
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
Cerebral Palsy (CP) in a diplegia features type imposes a series of commitments including abnormal gait, which makes the acquisition of a gross motor activity less elaborate. A variety of techniques have been used for the treatment and improvement of motor performance of children with CP. Among them the stationary cycling and Hippotherapy, according to some literature promotes a better performance in the assessment of gross motor function, as measured according to the GMFM88 protocol (Gross Motor Function Measure). Considering that the mentioned benefits cited arose from studies using independent techniques, the purpose associated with this research was to verify their effectiveness in a combined application on three children with spastic diplegia, aged between 5 and 10 years. All classified in levels 1 and 2 of the GMFCS. The results from the statistical parameters of the GMFM test revealed an improvement in the scores of items for all subjects, being significant for the individual who was trained in conjunction compared to those who made the practice of hippotherapy and stationary cycling, respectively. In percentage terms the improvement in the total of the two dimensions studied by the GMFM were 19%, 8% and 4% for the individual treatment associated hippotherapy and stationary cycling, in that order. For the two other instruments also used goniometry to assess passive range of motion of lower limb and Ashworth scale quantifying the degree of spasticity of the lower limb muscles showed positive gains for all participants. Likely that these gains reflected upon the improvement observed in gross motor skills.
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
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