Hand StrengthNCT02965352
Peripheral for Quantify Strength of Children Functional During the Pinch Movement
A study testing Door handle device, Linear switch device and Door key device in people with Hand Strength, run by University of Mogi das Cruzes.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Strength
- What is being tested?
- Door handle device, Linear switch device and Door key device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2015
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Hand Strength
- Being tested
- Door handle device, Linear switch device, Door key device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Door handle deviceDevice
To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion
Linear switch deviceDevice
To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.
Door key deviceDevice
To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Door handle device; 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.
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).
Measured: 15 minutes
Secondary outcomes (2)
range of motion in angle
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).
Measured: 15 minutes
range of motion in percentage
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 (%).
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 posted16 Nov 2016 (estimated)
- Study startJun 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand StrengthStudies 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, Silvia Regina M. S. Boschi, University of Mogi das Cruzes
- Investigators
- Silvia R Boschi, PhD, Principal investigator, University of Mogi das Cruzes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965352
- Sponsor's protocol ID
- 45883715.9.0000.5497
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral for Quantify Strength of Children Functional During the Pinch Movement
- ClinicalTrials.gov ID
- NCT02965352
- Acronym / sponsor ID
- 45883715.9.0000.5497
- Conditions
- Hand Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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 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.
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.
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: Door handle device, Device: Linear switch device, Device: Door key deviceVolunteers 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. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Door handle deviceTo evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion | Device | Hand strength |
| Linear switch deviceTo evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement. | Device | Hand strength |
| Door key deviceTo evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion | Device | Hand strength |
Primary outcome
Force
Time frame: 15 minutes
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).
2 secondary outcomes
range of motion in angle
Time frame: 15 minutes
range of motion in percentage
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 21 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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
Questions about this trial
What is this clinical trial studying?
A study testing Door handle device, Linear switch device and Door key device in people with Hand Strength, run by University of Mogi das Cruzes.
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 4 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 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Force (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 21 Nov 2016.