Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000129088
Ethics application status
Approved
Date submitted
4/02/2010
Date registered
9/02/2010
Date last updated
9/02/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Muscle adaptation to 14 days of immobilization after ankle aprain
Scientific title
Effect of ankle joint immobilization for second degree ankle sprain on electrical and functional properties of dorsi and plantarflexor muscles
Secondary ID [1] 1380 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Identify the electrical and functional adaptations of dorsiflexor and plantarflexor muscles after two weeks of immobilization in subjects who suffered ankle sprain 256749 0
Condition category
Condition code
Musculoskeletal 256904 256904 0 0
Other muscular and skeletal disorders
Injuries and Accidents 256916 256916 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
11 subjects who suffered a second degree of ankle sprain underwent 14 days of ankle joint immobilization with a plaster cast. After removal of the plaster cast, were obtained bilaterally evaluations of: (1) leg circumference; (2) ankle joint range of motion (ROM); (3) maximal isometric torque of plantar and dorsiflexors obtained in seven different angles; and (4) electromyographic signals of the tibialis anterior, gastrocnemius medialis and soleus muscles.
Intervention code [1] 255966 0
Treatment: Other
Comparator / control treatment
The injuried leg was compared with the contralateral health leg of the subjects.
Control group
Active

Outcomes
Primary outcome [1] 257772 0
After removal of the plaster cast, were obtained bilaterally evaluation of the maximal isometric torque of plantar and dorsiflexors obtained in seven different angles in an isokinetic dynamometer.
Timepoint [1] 257772 0
Within 24 hours after removal of the plaster cast.
Secondary outcome [1] 263175 0
After removal of the plaster cast, were obtained bilaterally evaluation of the electromyographic signals of the tibialis anterior, gastrocnemius medialis and soleus muscles.
Timepoint [1] 263175 0
Within 24 hours after removal of the plaster cast.

Eligibility
Key inclusion criteria
Subjects who suffered a second degree of ankle sprain underwent 14 days of ankle joint immobilization with a plaster cast.
Minimum age
20 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded from the study: subjects who suffered degree I or III ankle sprains; subjects who suffered another associate injuries (like fractures); subjects with previous history of injuries in lower limbs that may impair performance on isokinetic tests.

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
11
Accrual to date
Final
Recruitment outside Australia
Country [1] 2464 0
Brazil
State/province [1] 2464 0
Rio Grande do Sul

Funding & Sponsors
Funding source category [1] 256465 0
Self funded/Unfunded
Name [1] 256465 0
Country [1] 256465 0
Primary sponsor type
Individual
Name
Alessandra Quinteiro Galvao
Address
Exercise Research Laboratory
School of Physical Education
Federal University of Rio Grande do Sul
Rua Felizardo, 750
Porto Alegre, RS, Brazil
ZIP CODE 90690-200
Country
Brazil
Secondary sponsor category [1] 255774 0
Individual
Name [1] 255774 0
Marco Aurelio Vaz
Address [1] 255774 0
Exercise Research Laboratory
School of Physical Education
Federal University of Rio Grande do Sul
Rua Felizardo, 750
Porto Alegre, RS, Brazil
ZIP CODE 90690-200
Country [1] 255774 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258518 0
Ethics in Research Committee of Federal University of Rio Grande do Sul
Ethics committee address [1] 258518 0
Ethics committee country [1] 258518 0
Date submitted for ethics approval [1] 258518 0
Approval date [1] 258518 0
Ethics approval number [1] 258518 0

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

Contacts
Principal investigator
Name 30803 0
Address 30803 0
Country 30803 0
Phone 30803 0
Fax 30803 0
Email 30803 0
Contact person for public queries
Name 14050 0
Bruno Baroni
Address 14050 0
Exercise Research Laboratory
School of Physical Education
Federal University of Rio Grande do Sul
Rua Felizardo, 750
Porto Alegre, RS, Brazil
ZIP CODE 90690-200
Country 14050 0
Brazil
Phone 14050 0
55-51-33085859
Fax 14050 0
Email 14050 0
[email protected]
Contact person for scientific queries
Name 4978 0
Bruno Baroni
Address 4978 0
Exercise Research Laboratory
School of Physical Education
Federal University of Rio Grande do Sul
Rua Felizardo, 750
Porto Alegre, RS, Brazil
ZIP CODE 90690-200
Country 4978 0
Brazil
Phone 4978 0
55-51-33085859
Fax 4978 0
Email 4978 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.