- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03103048
Application of Different Techniques of Elastic Bandage
May 17, 2018 updated by: Terigi Augusto Scardovelli, University of Mogi das Cruzes
Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
This study will be featured as a randomized controlled.
As the dependent variable, was considered isometric grip manual force.
As independent variable, the presence or absence of forearm bandage in the fist flexor region of the volunteers.
Study Overview
Status
Completed
Conditions
Detailed Description
This study is directed to the population of students at the University of Mogi das Cruzes (UMC), and will take part of this study forty volunteers, twenty men and twenty women, aged from eighteen and thirty-eight years old.
Will be selected and included volunteers who do not do physical professional activity with upper members, which have no symptom of pain skeletal muscle in the upper members, which have not undergone any type of surgery in the region of the forearm and hand of both members.
Will be excluded the volunteers who have injuries, joint injuries, neuromuscular disorder or those who have knowledge of own vestibular or neurological changes.
Will also be excluded from study volunteers who do not agree to participate after reading and understanding of informed consent in accordance with resolution 466/12 of the National Ethics Committee and Research.
The data acquisition interface will be acquired by an electromyography e a standard of strentgh will maintened in forty Newtons assured by an electronic dynamometer for tests of palmar prehension without and with bandages.
The volunteers will not know what kind of intervention will pass.
After each application before testing, their both forearms will be covered with a protection.
The researcher and the volunteers will not know the tests order.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Mogi Das Cruzes, São Paulo, Brazil, 08615120
- Terigi Augusto Scardovelli
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 38 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Who do not do physical professional activity with upper members;
- Who have no symptom of pain skeletal muscle in the upper members;
- Who have not undergone any type of surgery in the region of the forearm and hand of both members;
- Consent form signed by the volunteer.
Exclusion Criteria:
- Having less than 18 years old;
- Having more than 38 years old;
- To present some compromise skeletal muscle in the upper members;
- Who do not want take part in the research;
- Who do not signed consent form as volunteer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages (start); 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
Placebo Comparator: Group 2
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo (start); 3 - With bandage; 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
Active Comparator: Group 3
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage (start); 4 - With tensioned bandage.
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
Active Comparator: Group 4
The tests will be performed in thirty days, session with lasting 15 minutes each, when all volunteers will be submitted in four measure tests: 1- Without bandages; 2 - With placebo; 3 - With bandage; 4 - With tensioned bandage (start).
|
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efforts
Time Frame: 15 minutes
|
Thru palmar prehension there will be data acquisition interface by an electromyography e a standard of strentgh maintened in 40 Newtons assured by an electronic dynamometer for tests of palmar prehension, with and without elastic adhesive bandages in the region of flexor muscle of fist.
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Terigi A Scardovelli, Ph.D., University of Mogi das Cruzes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2017
Primary Completion (Actual)
May 8, 2017
Study Completion (Actual)
June 21, 2017
Study Registration Dates
First Submitted
March 31, 2017
First Submitted That Met QC Criteria
March 31, 2017
First Posted (Actual)
April 6, 2017
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 17, 2018
Last Verified
April 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- CAAE 64513617.3.0000.5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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