- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03103048
Application of Different Techniques of Elastic Bandage
17. maj 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
São Paulo
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Mogi Das Cruzes, São Paulo, Brasilien, 08615120
- Terigi Augusto Scardovelli
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 38 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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 komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Efforts
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Terigi A Scardovelli, Ph.D., University of Mogi das Cruzes
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. april 2017
Primær færdiggørelse (Faktiske)
8. maj 2017
Studieafslutning (Faktiske)
21. juni 2017
Datoer for studieregistrering
Først indsendt
31. marts 2017
Først indsendt, der opfyldte QC-kriterier
31. marts 2017
Først opslået (Faktiske)
6. april 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. maj 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. maj 2018
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CAAE 64513617.3.0000.5497
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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