- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03103048
Application of Different Techniques of Elastic Bandage
17 maj 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
São Paulo
-
Mogi Das Cruzes, São Paulo, Brasilien, 08615120
- Terigi Augusto Scardovelli
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 38 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / 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-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Efforts
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Terigi A Scardovelli, Ph.D., University of Mogi das Cruzes
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 april 2017
Primärt slutförande (Faktisk)
8 maj 2017
Avslutad studie (Faktisk)
21 juni 2017
Studieregistreringsdatum
Först inskickad
31 mars 2017
Först inskickad som uppfyllde QC-kriterierna
31 mars 2017
Första postat (Faktisk)
6 april 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2018
Senast verifierad
1 april 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- CAAE 64513617.3.0000.5497
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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