Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000181606
Ethics application status
Approved
Date submitted
14/06/2013
Date registered
17/02/2014
Date last updated
17/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The efficiency of a program of psychomotor exercise balance of the elderly
Scientific title
The efficiency of a program of psychomotor exercise balance of the elderly
Secondary ID [1] 282678 0
none
Universal Trial Number (UTN)
U1111-1140-7116
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance 289380 0
elderly 289381 0
psychomotricity 289382 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289713 289713 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Psychomotor Exercises are indicated to improve certain difficulties in the execution of movements. Exercises such as rolling, crawling, motor coordination, gait crusade will be performed. Strategies such as awareness through brief explanations of what these exercises improve including the balance will be used to ensure that there is adherence to research. It was performed in group sessions under caring for a physiotherapist. The volunteers performed the psychomotor exercises with duration of 60 minutes, three times per week, during three months. After the end of the research, all the participants will return to re-perform the examinations of balance by Berg scale, stabilometry and even the baropodometry.
Intervention code [1] 287336 0
Rehabilitation
Comparator / control treatment
Control without psychomotor exercises
Control group
Active

Outcomes
Primary outcome [1] 289805 0
plantar surface area by baropodometry
Timepoint [1] 289805 0
12 weeks after intervention.
Primary outcome [2] 290319 0
average speed oscillatory and oscillation anteroposterior by baropodometry
Timepoint [2] 290319 0
12 weeks after intervention.
Primary outcome [3] 290320 0
gait speed by baropodometry
Timepoint [3] 290320 0
12 weeks after intervention.
Secondary outcome [1] 303275 0
Improvements in daily life activities. Quality of life questionnaire SF-36
Timepoint [1] 303275 0
12 weeks after intervention.

Eligibility
Key inclusion criteria
The inclusion criteria were: physical and social autonomy, without previous history of vertigo, fractures and who remained in orthostatism without aid.
Minimum age
65 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded from the study were those with gait changed, patients with visual problems, psychiatric illness or neurological disorders, the practitioners of regular physical activity and the use of any medication.

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
5/03/2010
Actual
1/06/2012
Date of last participant enrolment
Anticipated
30/07/2012
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5144 0
Brazil
State/province [1] 5144 0
RONDONIA

Funding & Sponsors
Funding source category [1] 287451 0
University
Name [1] 287451 0
COLLEGE SAO LUCAS
Country [1] 287451 0
Brazil
Primary sponsor type
Individual
Name
MARCELO C. RUBIRA
Address
AV. BRASILIA, 3062 , APTO 102
SAO CRISTOVAO
PORTO VELHO - RO
CEP 76804070
Country
Brazil
Secondary sponsor category [1] 286194 0
Individual
Name [1] 286194 0
ANA PAULA FERNANDES DE ANGELIS RUBIRA
Address [1] 286194 0
AV. BRASILIA, 3062 , APTO 102
SAO CRISTOVAO
PORTO VELHO - RO
CEP 76804070
Country [1] 286194 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289427 0
COLLEGE SAO LUCAS
Ethics committee address [1] 289427 0
Ethics committee country [1] 289427 0
Brazil
Date submitted for ethics approval [1] 289427 0
Approval date [1] 289427 0
22/02/2010
Ethics approval number [1] 289427 0
protocolo 561

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

Contacts
Principal investigator
Name 40786 0
Prof MARCELO C. RUBIRA
Address 40786 0
MARCELO C. RUBIRA
PROFESSOR OF THE SAO LUCAS COLLEGE
AV. BRASILIA, 3062 , APTO 102
SAO CRISTOVAO
PORTO VELHO-RO
CEP 76804-070
Country 40786 0
Brazil
Phone 40786 0
55 69 92289889
Fax 40786 0
Email 40786 0
[email protected]
Contact person for public queries
Name 40787 0
MARCELO C. RUBIRA
Address 40787 0
MARCELO C. RUBIRA
PROFESSOR OF THE SAO LUCAS COLLEGE
AV. BRASILIA, 3062 , APTO 102
SAO CRISTOVAO
PORTO VELHO-RO
CEP 76804-070
Country 40787 0
Brazil
Phone 40787 0
55 69 92289889
Fax 40787 0
Email 40787 0
[email protected]
Contact person for scientific queries
Name 40788 0
ANA PAULA FERNANDES DE ANGELIS RUBIRA
Address 40788 0
ANA PAULA FERNANDES DE ANGELIS RUBIRA
COORDINATOR OF THE PHYSIOTHERAPY COURSE SAO LUCAS COLLEGE
AV. BRASILIA, 3062 , APTO 102
SAO CRISTOVAO
PORTO VELHO-RO
CEP 76804-070
Country 40788 0
Brazil
Phone 40788 0
55 69 92289889
Fax 40788 0
Email 40788 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.