Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 2 of 2363 for:    QUANTIFY

Peripheral for Quantify Strength of Children Functional During the Pinch Movement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silvia Regina M. S. Boschi, University of Mogi das Cruzes
ClinicalTrials.gov Identifier:
NCT02965352
First received: November 8, 2016
Last updated: November 18, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention
Hand Strength
Device: Door handle device
Device: Linear switch device
Device: Door key device

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Peripheral for Quantify Strength of Children Functional During the Pinch Movement

Further study details as provided by University of Mogi das Cruzes:

Primary Outcome Measures:
  • Force [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • range of motion in angle [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    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).

  • range of motion in percentage [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    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 (%).


Enrollment: 30
Study Start Date: June 2015
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Device: 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.
Device: 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

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.
  Eligibility

Ages Eligible for Study:   7 Years to 10 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02965352

Sponsors and Collaborators
University of Mogi das Cruzes
Investigators
Principal Investigator: Silvia R Boschi, PhD University of Mogi das Cruzes
  More Information

Responsible Party: Silvia Regina M. S. Boschi, PhD, University of Mogi das Cruzes
ClinicalTrials.gov Identifier: NCT02965352     History of Changes
Other Study ID Numbers: 45883715.9.0000.5497 
Study First Received: November 8, 2016
Last Updated: November 18, 2016
Health Authority: Brazil: National Committee of Ethics in Research
Individual Participant Data  
Plan to Share IPD: Undecided

ClinicalTrials.gov processed this record on December 02, 2016