NCT03463447

Brief Summary

This study has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 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

Study Start

First participant enrolled

May 8, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

March 6, 2018

Last Update Submit

March 13, 2018

Conditions

Hand Strength

Keywords

DynamometerHandgripchildren

Outcome Measures

Primary Outcomes (1)

  • Force

    The force of handgrip, pinch pulp-side and pinch pulp-pulp movement. The test was measured 3 times with 1 minute interval . Unit of measurement: kilogram - force (kgf).

    15 minutes

Secondary Outcomes (3)

  • Anthropometric variables (weight)

    1 minute

  • Anthropometric variables (height)

    1 minute

  • Anthropometric variables (Measurements of the hands)

    3 minutes

Study Arms (1)

Hand strength

EXPERIMENTAL

We selected volunteers without motor abnormalities with aged 6 to 17 years divided in groups (n = 30) according to an age group. The tests were performed in a single session lasting 20 minutes, when volunteers used a hydraulic dynamometer and an electronic dynamometer, in order to quantify the hand strength.

Device: Electronic DynamometerDevice: Hydraulic dynamometer

Interventions

Electronic DynamometerDEVICE

Mensuration of the handgrip strength of each volunteer using an electronic dynamometer.

Hand strength
Hydraulic dynamometerDEVICE

Mensuration of the handgrip strength of each volunteer using a hydraulic dynamometer.

Hand strength

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • neurological disorder Absence
  • Informed Consent signed by the responsible
  • with preserved cognitive.
  • consent form signed by the volunteer

You may not qualify if:

  • change Absence of skeletal muscle in the upper limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silvia Regina Matos da Silva Boschi

Mogi das Cruzes, São Paulo, 08780-911, Brazil

Location

Study Officials

  • Silvia R Boschi, PhD

    University of Mogi das Cruzes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 13, 2018

Study Start

May 8, 2017

Primary Completion

September 4, 2017

Study Completion

November 23, 2017

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

BR(1)