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System for Quantifying the Functional Strength of the Grip and Pinch Movements

Primary Purpose

Hand Injuries and Disorders

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
handgrip strength
Door handle device
Tap device
Door pull handle
Linear Switch device
Door Key device
Sponsored by
University of Mogi das Cruzes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hand Injuries and Disorders

Eligibility Criteria

20 Years - 39 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Silvia Regina Matos da Silva Boschi

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hand strength

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Range of motion in angle
The test measured the range of motion of the door handle device, the tap device, door pull handle device and the door key device, 3 times with 1 minute interval for each test, in which all range of motion was measured from its start until its end. Unit of measure: Angle (º).
Range of motion millimeter
The test measured the range of motion in a linear switch device 3 times with a 1 minute interval for each test, in which all of the range of motion was measured from its start until its end. Unit measurement: millimeter (mm).

Full Information

First Posted
November 20, 2019
Last Updated
November 29, 2019
Sponsor
University of Mogi das Cruzes
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1. Study Identification

Unique Protocol Identification Number
NCT04174729
Brief Title
System for Quantifying the Functional Strength of the Grip and Pinch Movements
Official Title
System for Quantifying the Functional Strength of the Grip and Pinch Movements
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
October 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mogi das Cruzes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Quantifying grip and grip movement is essential as it allows for a basis in upper limb functionality. However, when there is access, it causes changes in the hands and changes the motor in relation to the force and range of motion, or generates changes in activities of daily living. Thus, a system with 5 devices, where each one the devices were prints in three-dimensional, and instrumented with force sensor for static-dynamic force analysis e potentiometer for analysis range of motion, during the execution of movements cylindrical grip, spherical grip, hook grip, pulp-pulp pinch, and pulp- side pinch in different activities of daily living. Elaborated a data storage interface through MATLAB® software that allows recording the data of each device. For the system functionality tests, 30 volunteers were selected for both sexes, young adults between 20 and 39 years old, students of the Physiotherapy and Graduate courses of the University of Mogi das Cruzes. The tests are divided into two sessions and are repeated after 7 days of the first test

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries and Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand strength
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
handgrip strength
Other Intervention Name(s)
Jamar dynamometer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Door handle device
Intervention Description
To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.
Intervention Type
Device
Intervention Name(s)
Tap device
Intervention Description
To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.
Intervention Type
Device
Intervention Name(s)
Door pull handle
Intervention Description
To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion
Intervention Type
Device
Intervention Name(s)
Linear Switch device
Intervention Description
To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.
Intervention Type
Device
Intervention Name(s)
Door Key device
Intervention Description
To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.
Primary Outcome Measure Information:
Title
Strength device
Description
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).
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Range of motion in angle
Description
The test measured the range of motion of the door handle device, the tap device, door pull handle device and the door key device, 3 times with 1 minute interval for each test, in which all range of motion was measured from its start until its end. Unit of measure: Angle (º).
Time Frame
15 minutes
Title
Range of motion millimeter
Description
The test measured the range of motion in a linear switch device 3 times with a 1 minute interval for each test, in which all of the range of motion was measured from its start until its end. Unit measurement: millimeter (mm).
Time Frame
15 minutes
Other Pre-specified Outcome Measures:
Title
Anthropometric variables
Description
The anthropometric measurement of the right hand was performed using an analog caliper, as it is an important parameter for functional evaluation, as it was of the following anatomical parts: total length of the hand (wrist crease to middle finger tip), longitudinal length of the palm from the hand (wrist crease to the proximal crease of the middle finger) and transverse length of the palm (lateral to medial line of the metacarpophalangeal muscles). Unit of measure: millimeter (mm)
Time Frame
5 minutes
Title
Dynamometer Jamar Strength
Description
To make the sample more homogeneous, the Jamar ® dynamometer was used to measure grip strength maximum contraction for 3 seconds. A single measurement was performed. Unit of measure: kilogram - force (kgf).
Time Frame
1 minute

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia R Boschi, PhD
Organizational Affiliation
University of Mogi das Cruzes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Silvia Regina Matos da Silva Boschi
City
Mogi das Cruzes
State/Province
São Paulo
ZIP/Postal Code
08780-911
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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System for Quantifying the Functional Strength of the Grip and Pinch Movements

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