Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000233022
Ethics application status
Approved
Date submitted
16/03/2010
Date registered
19/03/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Force Versus Electromyographic (EMG) Signals for Biofeedback in Isometric Training
Scientific title
Analysis of the Relationship Between Force and Electromyographic Signals used as Biofeedback for Isometric Muscle Strength Training in Healthy Volunteers
Secondary ID [1] 1518 0
None
Universal Trial Number (UTN)
U1111-1114-4273
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Muscle strength assesment 256975 0
Condition category
Condition code
Musculoskeletal 257120 257120 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The volunteers will perform three maximal voluntary isometric contractions of six seconds each with a period of 120 seconds of rest between each contraction and both force and eletromyographic siganls will be recorded during this assessment without visual and verbal feedback. After 10 minutes, training will be performed with series of maximal voluntary isometric contractions of six seconds duration each with a period of 120 seconds of rest between each contraction and 180 seconds of rest between each serie with visual feedback. In each of them volunteers were encouraged to surpass 10 % (updated for each new series) of the reference value. If the volunteer was not able to reach this value in the next series, an adjustment was made lowering 5 % and, if they failed again, training was halt at this point. After training force and eletromyographic signals will be compared.
Intervention code [1] 256152 0
Rehabilitation
Comparator / control treatment
Control group will perform isometric contractions without biofeedback
Control group
Active

Outcomes
Primary outcome [1] 258014 0
force and eletromyographic signal
Timepoint [1] 258014 0
before and during intervention
Secondary outcome [1] 263579 0
muscular strength
Timepoint [1] 263579 0
before and during intervention

Eligibility
Key inclusion criteria
Age 18-25, gender: female, healthy individuals, non sedentary lifestyle
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of lower limb injury, previous history of knee surgery, neurological and / or visual and auditory deficits

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment outside Australia
Country [1] 2542 0
Brazil
State/province [1] 2542 0
Paraiba

Funding & Sponsors
Funding source category [1] 256657 0
University
Name [1] 256657 0
Universidade Federal da Paraiba (UFPB)
Country [1] 256657 0
Brazil
Primary sponsor type
Individual
Name
Francisco Locks Neto
Address
Departamento de Fisioterapia da UFPB - Cidade Universitaria - Joao Pessoa - PB - Brasil - CEP - 58059-900
Country
Brazil
Secondary sponsor category [1] 255945 0
Individual
Name [1] 255945 0
Jose Jamacy de Almeida Ferreira
Address [1] 255945 0
Departamento de Fisioterapia da UFPB - Cidade Universitaria - Joao Pessoa - PB - Brasil - CEP - 58059-900
Country [1] 255945 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258679 0
Comite de Etica do Centro de Ciencias da Saude da UFPB
Ethics committee address [1] 258679 0
Cidade Universitaria - Joao Pessoa - PB - Brasil - CEP - 58059-900
Ethics committee country [1] 258679 0
Date submitted for ethics approval [1] 258679 0
Approval date [1] 258679 0
Ethics approval number [1] 258679 0

Summary
Brief summary
To compare the gain of strength and electrical activation of the quadriceps femoris muscle of subjects undergoing biofeedback training using force and EMG signals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30942 0
Address 30942 0
Country 30942 0
Phone 30942 0
Fax 30942 0
Email 30942 0
Contact person for public queries
Name 14189 0
Jose Jamacy de Almeida Ferreira
Address 14189 0
Departamento de Fisioterapia - Cidade Universitaria - Joao Pessoa - PB - Brasil - CEP - 58059-900
Country 14189 0
Brazil
Phone 14189 0
55 83 3216 7183/ 55 83 3216 7718
Fax 14189 0
Email 14189 0
[email protected]
Contact person for scientific queries
Name 5117 0
Jose Jamacy de Almeida Ferreira
Address 5117 0
Departamento de Fisioterapia - Cidade Universitaria - Joao Pessoa - PB - Brasil - CEP - 58059-900
Country 5117 0
Brazil
Phone 5117 0
55 83 3216 7183/ 55 83 3216 7718
Fax 5117 0
Email 5117 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.