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Trial registered on ANZCTR


Registration number
ACTRN12609000866202
Ethics application status
Approved
Date submitted
8/10/2008
Date registered
6/10/2009
Date last updated
6/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mechanomyography as a technique for the detection of muscle fatigue during neuromuscular electrical stimulation
Scientific title
Mechanomyography as a technique for the detection of muscle fatigue and correlation with muscular torque during neuromuscular electrical stimulation in healthy volunteers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
muscle fatigue 3801 0
preventive interventions 3802 0
Condition category
Condition code
Musculoskeletal 3983 3983 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
application of electrical stimulation (burst rate of 50 Hertz, pulse duration of 400 microseconds during 120 seconds) to the quadriceps muscle of ten healthy and sedentary volunteers and simultaneous acquisition of mechanomyographic signal (amplitude and frequency parameters) and torque (magnitude).
Intervention code [1] 3523 0
Not applicable
Comparator / control treatment
there was no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4885 0
Mechanomyographic parameters (amplitude and frequency) detect or do not detect muscle fatigue
Timepoint [1] 4885 0
this observation is performed during the whole experiment
Secondary outcome [1] 8243 0
linear correlation between mechanomyography and torque
Timepoint [1] 8243 0
this observation is performed during the whole experiment

Eligibility
Key inclusion criteria
sedentary and healthy volunteers with no history of neuromuscular disease
Minimum age
18 Years
Maximum age
40 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
volunteers with neuromuscular diseases

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1251 0
Brazil
State/province [1] 1251 0

Funding & Sponsors
Funding source category [1] 3986 0
University
Name [1] 3986 0
Pontificia Universidade Catolica do Parana
Address [1] 3986 0
Rua Imaculada Conceicao, 1155, Prado Velho, Curitiba, Parana, ZIP 80215-901
Country [1] 3986 0
Brazil
Primary sponsor type
Individual
Name
Dr. Percy Nohama
Address
Rua Imaculada Conceicao, 1155, Prado Velho, Curitiba, Parana, ZIP 80215-901
Country
Brazil
Secondary sponsor category [1] 3575 0
None
Name [1] 3575 0
Address [1] 3575 0
Country [1] 3575 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6061 0
Comite de Etica em Pesquisa com Seres Humanos da PUCPR
Ethics committee address [1] 6061 0
Rua Imaculada Conceicao, 1155, Prado Velho, Curitiba, Parana, ZIP 80215-901
Ethics committee country [1] 6061 0
Brazil
Date submitted for ethics approval [1] 6061 0
Approval date [1] 6061 0
Ethics approval number [1] 6061 0

Summary
Brief summary
The main purpose is to determine whether mechanomyography signals suffer significant changes during fatiguing muscle contractions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29016 0
Address 29016 0
Country 29016 0
Phone 29016 0
Fax 29016 0
Email 29016 0
Contact person for public queries
Name 12173 0
Lilian Faller
Address 12173 0
Rua Imaculada Conceicao, 1155, Prado Velho, Curitiba, Parana, ZIP 80215-901
CCBS PPGTS department Att.: Lilian Faller
Country 12173 0
Brazil
Phone 12173 0
+55 41 32711657
Fax 12173 0
Email 12173 0
percy@ppgia.pucpr.br
Contact person for scientific queries
Name 3101 0
Lilian Faller
Address 3101 0
Rua Imaculada Conceicao, 1155, Prado Velho, Curitiba, Parana, ZIP 80215-901
CCBS PPGTS department Att.: Lilian Faller
Country 3101 0
Brazil
Phone 3101 0
+55 41 32711657
Fax 3101 0
Email 3101 0
percy@ppgia.pucpr.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary