Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000534088
Ethics application status
Approved
Date submitted
25/05/2010
Date registered
1/07/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
effect of hippotherapy in the balance of elderly
Scientific title
The hippotherapy for improve effectiveness balance in elderly
Secondary ID [1] 252088 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
balance 257621 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257598 257598 0 0
Other physical medicine / rehabilitation
Other 257797 257797 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HIPPOTHERAPY - therapeutical and educational method that uses the horse inside an interdisciplinary program board, in the areas of health, education and riding. One on one with a trained hippotherapist and horse, along with the 1/2 hour sessions two a week, for a total of 8 weeks.
Intervention code [1] 256544 0
Other interventions
Comparator / control treatment
Don't have control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258596 0
Primary Outcome 1: improve balance in Elderly.The acquisition of the data of the balance was carried through by means of the force of platform mark AMTI (Force Measurement Systems, USA), model Accusway Plus. To clinical analysis of the seated balance, transferences of seated for the position in foot, stability in the deambulation and changes of the course of the march, it was used the Timed Get Up and Go test (TUG)
Timepoint [1] 258596 0
Timepoint: After 16 sections of Hippotherapy
Secondary outcome [1] 264489 0
Secondary Outcome 1: Improve "Timed Get Up and Go" test in Elderly
Timepoint [1] 264489 0
Timepoint: After 16 sections of Hippotherapy

Eligibility
Key inclusion criteria
* Elderly that is able to carry through its activities of daily life independently;
* Elderly that has certified doctor who informs that he is apt for Hippotherapy practises.
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Elderly that had regularly practised physical activity in the last the 3 months;
* Elderly that is not able to be on foot, without support, in the platform;
* Elderly that presents cognitive deficit;
* Elderly with disturbances that determine deficits of balance;
* Elderly with Cardiac and osteoporosis problems that is considered disabled to make physical exercise;
* Elderly that presents phobia to the animal.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
14/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2655 0
Brazil
State/province [1] 2655 0
Brasilia

Funding & Sponsors
Funding source category [1] 257039 0
Self funded/Unfunded
Name [1] 257039 0
Marisete Peralta Safons
Country [1] 257039 0
Brazil
Funding source category [2] 257043 0
University
Name [2] 257043 0
Universidade de Brasilia
Country [2] 257043 0
Brazil
Primary sponsor type
Individual
Name
Marisete Peralta Safons
Address
Campus Universitario Darcy Ribeiro 70910-900 Brasilia-DF
Country
Brazil
Secondary sponsor category [1] 256467 0
University
Name [1] 256467 0
Universidade de Brasilia
Address [1] 256467 0
Campus Universitario Darcy Ribeiro 70910-900 Brasilia-DF - Brasil
Country [1] 256467 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259054 0
Committee of Ethics in Research - College of Sciences of the Health (CEP/FS)
Ethics committee address [1] 259054 0
Campus Universitario Darcy Ribeiro; CEP-70910-900; Brasilia-DF
Ethics committee country [1] 259054 0
Brazil
Date submitted for ethics approval [1] 259054 0
03/08/2009
Approval date [1] 259054 0
14/10/2009
Ethics approval number [1] 259054 0
CAAE: 0079.0.012.000-09

Summary
Brief summary
Objective: to verify if the hippotherapy is able to produce alterations in the postural balance of elderly. Methods: A controlled experimental study was developed. The sample selected between elderly of the community, characterizing as a sample of convenience, composed of 17 aged ones, divided in experimental group (7 subjects) and a group controlled (10 subjects). The acquisition of the data of the stabilometry was carried through by means of the force of platform mark AMTI (Force Measurement Systems, USA), model Accusway Plus. To clinical analysis of the seated balance, transferences of seated for the position in foot, stability in the deambulation and changes of the course of the march, it was used the Timed Get Up and Go test (TUG). 16 sessions of hippotherapy in the Basic Center of Hippotherapy of the Institute Cavalo Solidario, located in the Agricultural Nucleus Alexander Gusmao, Mansion 3/465 - DF. Results: In the comparison of the averages between the groups through the test of Mann-Witney, there were not significant difference in the analyzed stabilometric parameters. Already in the comparison of the averages intra group through the test of Wilcoxon, it was verified significant increase on the variable COPy and Area (p = 0,02). The averages between the experimental and control groups through the test of Mann-Witney, for analysis of test TUG were verified significant effect (p = 0,04) of the hippotherapy. In the comparison of the averages intra group through the test of Wilcoxon, was verified significant effect (p = 0,04) on the variable TUG. Conclusion: The senescence tends to normalize the stabilometric measures, being insufficient with this number of hippotherapy sessions to point on differences to this intervention. However, this frequency of treatment was enough as preditor of lesser risk of falls in elderly since the TUG test showed significant reduction of time necessary to execute it.
Trial website
www.gepafi.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31214 0
Address 31214 0
Country 31214 0
Phone 31214 0
Fax 31214 0
Email 31214 0
Contact person for public queries
Name 14461 0
Marisete Peralta Safons
Address 14461 0
Universidade de Brasilia- Centro Olimpico -
Campus Universitario Darcy Ribeiro, CEP - 70910-900 Brasilia-DF – Brazil
Country 14461 0
Brazil
Phone 14461 0
55-61-31072557
Fax 14461 0
55-61-31072544
Email 14461 0
mari7ps@gmail.com
Contact person for scientific queries
Name 5389 0
Thais Borges de Araujo
Address 5389 0
QBR 5 bloco j apartamento 12 Residencial Santos Dumond- Santa Maria – CEP 712000300 - Brasilia- Brazil
Country 5389 0
Brazil
Phone 5389 0
55-61-81656995
Fax 5389 0
55-61-31072544
Email 5389 0
fisioterapeuta.thais@gmail.com

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
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Documents added automatically
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