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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02965352
Other study ID # 45883715.9.0000.5497
Secondary ID
Status Completed
Phase N/A
First received November 8, 2016
Last updated November 18, 2016
Start date June 2015
Est. completion date December 2015

Study information

Verified date November 2016
Source University of Mogi das Cruzes
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

This study has developed a peripheral to quantify the functional strength of children without motor change during the movement of grip and pinch. It was possible to know the exact values of these strengths, the range of motion that was made, and also if the grip strength was maintained during all the arc of motion.


Description:

Since childhood, it has been necessary to produce sufficient force to grip and pinch, for performing daily tasks independently; therefore, measurements of these forces end up being useful markers to evaluate the performance and the physical development of the child. It was developed a peripheral containing three devices and instrumented for analyzing the force applied during execution of the cylindrical grip movement, pinch pulp-side and pinch pulp-pulp in different situations of the daily life of the volunteer. The data acquisition interface was developed in a software for data recording. For the peripheral functionality tests, thirty volunteers of both genders were selected. They were also students of the Sports Secretary, with no motor abnormalities, between seven and ten years old.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria:

- change Absence of skeletal muscle in the upper limbs

- neurological disorder Absence

- Informed Consent signed by the responsible

- with preserved cognitive.

- consent form signed by the volunteer

Exclusion Criteria:

- Having less than 7 years old

- Having more than 10 years old

- To present some compromise skeletal muscle in the upper limbs

- not take part in the research

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Device:
Door handle device
To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion
Linear switch device
To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.
Door key device
To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Mogi das Cruzes

Outcome

Type Measure Description Time frame Safety issue
Primary Force The force of cylindrical grip movement was measured through a door handle device, pinch pulp-side through a door key and pinch pulp-pulp movement through a switch. The test was measured 3 times with 1 minute interval and it was measured the strength during all arc of motion. Unit of measurement: Newton (N). 15 minutes Yes
Secondary range of motion in angle The test measured the range of motion in a door handle device and in a door key device 3 times with 1 minute interval for each test, in which all the range of motion was measured from its start until its end. Unit of measurement: Angle (ยบ). 15 minutes Yes
Secondary range of motion in percentage The test measured the range of motion in a linear switch device 3 times with 1 minute interval for each test, in which all of the range of motion was measured from its start until its end. Unit measurement: Percentage (%). 15 minutes Yes
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