NCT03103048

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2017

Completed
Last Updated

May 18, 2018

Status Verified

April 1, 2017

Enrollment Period

1 month

First QC Date

March 31, 2017

Last Update Submit

May 17, 2018

Conditions

Forearm Muscle Strain

Outcome Measures

Primary Outcomes (1)

  • Efforts

    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

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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 bandagesDiagnostic Test: With placeboDiagnostic Test: With bandageDiagnostic Test: With tensioned bandage

Group 2

PLACEBO COMPARATOR

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 bandagesDiagnostic Test: With placeboDiagnostic Test: With bandageDiagnostic Test: With tensioned bandage

Group 3

ACTIVE COMPARATOR

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 bandagesDiagnostic Test: With placeboDiagnostic Test: With bandageDiagnostic Test: With tensioned bandage

Group 4

ACTIVE COMPARATOR

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 bandagesDiagnostic Test: With placeboDiagnostic Test: With bandageDiagnostic Test: With tensioned bandage

Interventions

Without bandagesDIAGNOSTIC_TEST

All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore

Group 1Group 2Group 3Group 4
With placeboDIAGNOSTIC_TEST

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

Group 1Group 2Group 3Group 4
With bandageDIAGNOSTIC_TEST

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

Group 1Group 2Group 3Group 4
With tensioned bandageDIAGNOSTIC_TEST

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

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 38 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Terigi Augusto Scardovelli

Mogi das Cruzes, São Paulo, 08615120, Brazil

Location

Study Officials

  • Terigi A Scardovelli, Ph.D.

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

April 3, 2017

Primary Completion

May 8, 2017

Study Completion

June 21, 2017

Last Updated

May 18, 2018

Record last verified: 2017-04

Locations

BR(1)