NCT02965352

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

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

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

November 8, 2016

Last Update Submit

November 18, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • range of motion in angle

    15 minutes

  • range of motion in percentage

    15 minutes

Study Arms (1)

Hand strength

EXPERIMENTAL

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 deviceDevice: Linear switch deviceDevice: Door key device

Interventions

To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion

Hand strength

To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.

Hand strength

To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion

Hand strength

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

November 8, 2016

First Posted

November 16, 2016

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 21, 2016

Record last verified: 2016-11