Hand Injuries and DisordersNCT04174729
System for Quantifying the Functional Strength of the Grip and Pinch Movements
A study testing handgrip strength, Door handle device and Tap device in people with Hand Injuries and Disorders, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Injuries and Disorders
- What is being tested?
- handgrip strength, Door handle device and Tap device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to 29 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Silvia Regina Matos da Silva Boschi
Mogi das Cruzes, São Paulo, 08780-911
About this study
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.
Read the 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
- Conditions
- Hand Injuries and Disorders
- Being tested
- handgrip strength, Door handle device, Tap device, Door pull handle, Linear Switch device
- Medical subject headings
- Hand Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
handgrip strengthDevice
Also called Jamar dynamometer
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.
Door handle deviceDevice
To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.
Tap deviceDevice
To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.
Door pull handleDevice
To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion
Linear Switch deviceDevice
To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.
Door Key deviceDevice
To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: handgrip strength; Device: Door handle device; Device: Tap device; Device: Door pull handle; Device: Linear Switch device; Device: Door Key device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 minutes
Secondary outcomes (2)
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).
Measured: 15 minutes
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).
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start5 Aug 2019
- Primary completion9 Sep 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Injuries and DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mogi das Cruzes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Terigi Augusto Scardovelli, University of Mogi das Cruzes
- Investigators
- Silvia R Boschi, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04174729
- Sponsor's protocol ID
- 19020219.2.0000.5497
- Status last verified
- Nov 2019
- First submitted
- 20 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System for Quantifying the Functional Strength of the Grip and Pinch Movements
- ClinicalTrials.gov ID
- NCT04174729
- Acronym / sponsor ID
- 19020219.2.0000.5497
- Conditions
- Hand Injuries and Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand strength | Experimental | Device: handgrip strength, Device: Door handle device, Device: Tap device, Device: Door pull handle, Device: Linear Switch device, Device: Door Key deviceThe 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. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| handgrip strengthAlso: Jamar dynamometerFirst, 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. | Device | Hand strength |
| Door handle deviceTo evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion. | Device | Hand strength |
| Tap deviceTo evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion. | Device | Hand strength |
| Door pull handleTo assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion | Device | Hand strength |
| Linear Switch deviceTo evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement. | Device | Hand strength |
| Door Key deviceTo assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion. | Device | Hand strength |
Primary outcome
Strength device
Time frame: 15 minutes
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).
2 secondary outcomes
Range of motion in angle
Time frame: 15 minutes
Range of motion millimeter
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia R Boschi, PhD principal investigator
University of Mogi das Cruzes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing handgrip strength, Door handle device and Tap device in people with Hand Injuries and Disorders, run by University of Mogi das Cruzes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength device (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.