- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02965352
Peripheral for Quantify Strength of Children Functional During the Pinch Movement
November 18, 2016 updated by: Silvia Regina M. S. Boschi, University of Mogi das Cruzes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hand strength
Volunteers without motor abnormalities.
The tests were performed in a single session lasting 30 minutes, when volunteers used the door handle device, the linear switch device, and the door key device, in order to quantify the hand strength.
|
To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion
To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.
To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Force
Time Frame: 15 minutes
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
range of motion in angle
Time Frame: 15 minutes
|
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 (º).
|
15 minutes
|
range of motion in percentage
Time Frame: 15 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia R Boschi, PhD, University of Mogi das Cruzes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 8, 2016
First Submitted That Met QC Criteria
November 11, 2016
First Posted (Estimate)
November 16, 2016
Study Record Updates
Last Update Posted (Estimate)
November 21, 2016
Last Update Submitted That Met QC Criteria
November 18, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 45883715.9.0000.5497
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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