Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000946011
Ethics application status
Approved
Date submitted
29/10/2010
Date registered
5/11/2010
Date last updated
5/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physiotherapy post-immobilization in an ankle fracture: case report
Scientific title
Patient within 45 days of immobilization after correction of ankle fracture, underwent physical therapy, achieving an increase in amplitude motion, muscle hypertrophy, the balance and quality of life of patients
Secondary ID [1] 252661 0
002.08.010 Ethics Committee of the Instituto de Molestias Cardiovasculares - IMC
Universal Trial Number (UTN)
U1111-1116-8729
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
immobilization after ankle fracture repair 258157 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258336 258336 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment was administered by a physiotherapist and lasted 12 weeks with sessions of 45 minutes five times a week, with hydrotherapy (03 times per week for 45 minutes), stretching (held for 30 seconds), muscle strength (03 times for 08 iterations), training proprioception (02 times per week for 20 minutes) and plyometrics (02 times per week for 20 minutes), the last week of treatment was given fitness (03 times per week for 45 minutes).
Intervention code [1] 257178 0
Treatment: Other
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259189 0
Increased range of motion in flexion of 19 degrees and 11 degrees of dorsiflexion measured through goniometry
Timepoint [1] 259189 0
12 weeks
Primary outcome [2] 259534 0
Improving quality of life by Short Form Health Survey Questionnaire in the areas of functional capacity, physical state, in their overall health, reduced by social constraints and worsening mental health.
Timepoint [2] 259534 0
12 weeks
Primary outcome [3] 259535 0
Standardization of the second equilibrium: Performance-Oriented Mobility Assessment of Gait and Balance Scale and the Berg Balance, reaching maximum score by the performance
Timepoint [3] 259535 0
12 weeks
Secondary outcome [1] 265551 0
improved function of the ankle, by inspection of gait
Timepoint [1] 265551 0
12 weeks
Secondary outcome [2] 266150 0
improved quality of life, by Questionnaire Short Form Health Survey
Timepoint [2] 266150 0
12 weeks

Eligibility
Key inclusion criteria
immobilization for 45 days for correction of ankle fracture
Minimum age
21 Years
Maximum age
21 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
no immobilization postoperatively

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)
Study with commitment and clear to the patient, with liberty to quit the study at the time thought necessary.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1
Accrual to date
Final
Recruitment outside Australia
Country [1] 2860 0
Brazil
State/province [1] 2860 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 257952 0
University
Name [1] 257952 0
Centro Universitario de Rio Preto
Country [1] 257952 0
Brazil
Primary sponsor type
Individual
Name
Joao Simao de Melo Neto
Address
Street Joaquim Manoel Pires, 333, ap. 11, Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country
Brazil
Secondary sponsor category [1] 257153 0
Individual
Name [1] 257153 0
Larice Cristina de Carvalho
Address [1] 257153 0
Avenue Clovis oger, 666, Distrito Industrial, Sao Jose do Rio Preto, Sao Paulo, CEP 15035-580
Country [1] 257153 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259993 0
Comite de Etica em Pesquisa do Instituto de Molestias Cardiovasculares
Ethics committee address [1] 259993 0
Ethics committee country [1] 259993 0
Brazil
Date submitted for ethics approval [1] 259993 0
27/07/2010
Approval date [1] 259993 0
02/08/2010
Ethics approval number [1] 259993 0
002.08.010

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

Contacts
Principal investigator
Name 31625 0
Address 31625 0
Country 31625 0
Phone 31625 0
Fax 31625 0
Email 31625 0
Contact person for public queries
Name 14872 0
Joao Simao de Melo Neto
Address 14872 0
street Joaquim Manoel Pires,111 - Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country 14872 0
Brazil
Phone 14872 0
+55 17 96174258
Fax 14872 0
+55 17 32116060
Email 14872 0
[email protected]
Contact person for scientific queries
Name 5800 0
Joao Simao de Melo Neto
Address 5800 0
street Joaquim Manoel Pires,111 - Sao Manoel, Sao Jose do Rio Preto, Sao Paulo, CEP 15091-210
Country 5800 0
Brazil
Phone 5800 0
+55 17 96174258
Fax 5800 0
+55 17 32116060
Email 5800 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.