NCT04174729

Brief Summary

This study developed a system to quantify the functional strength of young adults without motor impairment during grip and pinch movement. Making it possible to know the accuracy of the value of these strength, the range of motion performed and whether the grip force was maintained throughout the range of motion. In addition to checking the functionality, reliability and reproducibility of the system.

Trial Health

87
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 Aug 2019

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

August 5, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2019

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 20, 2019

Last Update Submit

November 29, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Strength device

    The strength of the cylindrical grip movement was quantified through the door handle device, the spherical grip strength through the tap device, the hook grip strength through the vertical door pull handle, the pulp-pulp pinch strength through the linear switch device and the pulp-side pinch strength through the key device. The test was quantified 3 times with a 1 minute interval between each test and the force throughout the range of motion. Unit of measure: newton (N).

    15 minutes

Secondary Outcomes (2)

  • Range of motion in angle

    15 minutes

  • Range of motion millimeter

    15 minutes

Other Outcomes (2)

  • Anthropometric variables

    5 minutes

  • Dynamometer Jamar Strength

    1 minute

Study Arms (1)

Hand strength

EXPERIMENTAL

The tests were performed in two sessions lasting 1 hour each. The volunteers used the devices: door handle, tap, door pull handle, switch and door key to quantify hand strength. The tests were performed in two sessions lasting 1 hour each. The volunteers used the devices: door handle, tap, door pull handle, switch and door key to quantify hand strength. In the first session, the volunteers performed the movements 3 times in each device of daily living activities with the right limb, with a 1-minute rest interval between the 3 measurements. The entire procedure performed in the session was repeated again after 30 minutes to verify the reliability and reproducibility of the Intra-evaluator test. The Inter-rater test was repeated after 7 days by the second rater to analyze reliability between the rater.

Device: handgrip strengthDevice: Door handle deviceDevice: Tap deviceDevice: Door pull handleDevice: Linear Switch deviceDevice: Door Key device

Interventions

First, the hand measurements of each volunteer were evaluated, followed by the measurement of handgrip strength using the Jamar® dynamometer. And later the tests were performed using the system that contains the 5 devices to quantify the hand strength.

Also known as: Jamar dynamometer
Hand strength

To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.

Hand strength

To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.

Hand strength

To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion

Hand strength

To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.

Hand strength

To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.

Hand strength

Eligibility Criteria

Age20 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • only right-handed individuals,
  • male and female,
  • have preserved cognitive functions,
  • absence of neurological disorder
  • who present minimum grip strength by the Jamar ® dynamometer, in the age group of 20-29 years men 45.08 ± 0.67 kg and women of 27.2 ± 0.46 kg, who present minimum grip strength by the dynamometer Jamar ®, aged 30 to 39 years old men 46.05 ± 0.47 kg and women 28.0 ± 0.39 kg, using the mean minus the standard deviation.

You may not qualify if:

  • Injury to upper limbs such as amputation, recent surgery (6 months), fractures, bruising, pain and musculoskeletal disorders.
  • Do not accept to participate in the survey.

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

MeSH Terms

Conditions

Hand InjuriesDisease

Condition Hierarchy (Ancestors)

Wounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Principal Investigator

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 22, 2019

Study Start

August 5, 2019

Primary Completion

September 9, 2019

Study Completion

October 29, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations