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Application of Different Techniques of Elastic Bandage

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ClinicalTrials.gov Identifier: NCT03103048
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Terigi Augusto Scardovelli, University of Mogi das Cruzes

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Forearm Muscle Strain Diagnostic Test: Without bandages Diagnostic Test: With placebo Diagnostic Test: With bandage Diagnostic Test: With tensioned bandage Not Applicable

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Application of Different Techniques of Elastic Bandage: Quantification Electromyographic at the Isometric Effort of Flexor Muscle of Fist
Actual Study Start Date : April 3, 2017
Actual Primary Completion Date : May 8, 2017
Actual Study Completion Date : June 21, 2017

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.
Diagnostic Test: Without bandages
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore

Diagnostic Test: With placebo
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members

Diagnostic Test: With bandage
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members

Diagnostic Test: With tensioned bandage
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.
Diagnostic Test: Without bandages
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore

Diagnostic Test: With placebo
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members

Diagnostic Test: With bandage
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members

Diagnostic Test: With tensioned bandage
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.
Diagnostic Test: Without bandages
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore

Diagnostic Test: With placebo
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members

Diagnostic Test: With bandage
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members

Diagnostic Test: With tensioned bandage
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).
Diagnostic Test: Without bandages
All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore

Diagnostic Test: With placebo
All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members

Diagnostic Test: With bandage
All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members

Diagnostic Test: With tensioned bandage
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103048


Locations
Brazil
Terigi Augusto Scardovelli
Mogi Das Cruzes, São Paulo, Brazil, 08615120
Sponsors and Collaborators
University of Mogi das Cruzes
Investigators
Principal Investigator: Terigi A Scardovelli, Ph.D. University of Mogi das Cruzes

Responsible Party: Terigi Augusto Scardovelli, Principal Investigator, University of Mogi das Cruzes
ClinicalTrials.gov Identifier: NCT03103048     History of Changes
Other Study ID Numbers: CAAE 64513617.3.0000.5497
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No