Hand StrengthNCT03463447
Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer
A study testing Electronic Dynamometer and Hydraulic dynamometer in people with Hand Strength, run by University of Mogi das Cruzes at 1 site in Brazil.
Trial summary
This study has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Strength
- What is being tested?
- Electronic Dynamometer and Hydraulic dynamometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- 8 May 2017to 23 Nov 2017
- 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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neurological disorder Absence
- Informed Consent signed by the responsible
- with preserved cognitive.
- consent form signed by the volunteer
Who cannot join
- change Absence of skeletal muscle in the upper limbs
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 has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer.
Read the detailed description
The hand is considered the most improved tool and differentiated of the human, with great importance in the accomplishment of numerous actions due to an essential function: The handgrip strength. The handgrip and pinch movements are very important for an accomplishment of daily activities. For an evaluation of the movements, the dynamometry has been used in many fields of health and frequently in the area of rehabilitation. However, if the type of dynamometer used is not suitable for children, a measurement of the handgrip may be compromised. Therefore, the present study verified the effectiveness of an electronic dynamometer to evaluate the handgrip strength and pinch in children and adolescents.
- Conditions
- Hand Strength
- Being tested
- Electronic Dynamometer, Hydraulic dynamometer
- Keywords
- Dynamometer, Handgrip, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic DynamometerDevice
Mensuration of the handgrip strength of each volunteer using an electronic dynamometer.
Hydraulic dynamometerDevice
Mensuration of the handgrip strength of each volunteer using a hydraulic dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Hand strength | Experimental | We selected volunteers without motor abnormalities with aged 6 to 17 years divided in groups (n = 30) according to an age group. The tests were performed in a single session lasting 20 minutes, when volunteers used a hydraulic dynamometer and an electronic dynamometer, in order to quantify the hand strength. Receives: Device: Electronic Dynamometer; Device: Hydraulic dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force
The force of handgrip, pinch pulp-side and pinch pulp-pulp movement. The test was measured 3 times with 1 minute interval . Unit of measurement: kilogram - force (kgf).
Measured: 15 minutes
Secondary outcomes (3)
Anthropometric variables (weight)
weight of the volunteer. Unit of measurement: kilogram (Kg)
Measured: 1 minute
Anthropometric variables (height)
height of the volunteer. Unit of measurement: meters (m)
Measured: 1 minute
Anthropometric variables (Measurements of the hands)
Measurements of the hands of each volunteer were evaluated. Unit of measurement: centimeters (cm)
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start8 May 2017
- Primary completion4 Sep 2017
- Study completion23 Nov 2017
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
- 360 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
- NCT03463447
- Sponsor's protocol ID
- CAAE: 67689517.7.0000.5497
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer
- ClinicalTrials.gov ID
- NCT03463447
- Acronym / sponsor ID
- CAAE: 67689517.7.0000.5497
- Conditions
- Hand Strength
- Keywords
- Dynamometer, Handgrip, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of Mogi das CruzesUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 23 Nov 2017 (actual)
- First posted
- 13 Mar 2018 (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 has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer.
Detailed description
The hand is considered the most improved tool and differentiated of the human, with great importance in the accomplishment of numerous actions due to an essential function: The handgrip strength. The handgrip and pinch movements are very important for an accomplishment of daily activities. For an evaluation of the movements, the dynamometry has been used in many fields of health and frequently in the area of rehabilitation. However, if the type of dynamometer used is not suitable for children, a measurement of the handgrip may be compromised. Therefore, the present study verified the effectiveness of an electronic dynamometer to evaluate the handgrip strength and pinch in children and adolescents.
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: Electronic Dynamometer, Device: Hydraulic dynamometerWe selected volunteers without motor abnormalities with aged 6 to 17 years divided in groups (n = 30) according to an age group. The tests were performed in a single session lasting 20 minutes, when volunteers used a hydraulic dynamometer and an electronic dynamometer, in order to quantify the hand strength. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- neurological disorder Absence
- Informed Consent signed by the responsible
- with preserved cognitive.
- consent form signed by the volunteer
Key exclusion criteria (1 listed)
- change Absence of skeletal muscle in the upper limbs
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 |
|---|---|---|
| Electronic DynamometerMensuration of the handgrip strength of each volunteer using an electronic dynamometer. | Device | Hand strength |
| Hydraulic dynamometerMensuration of the handgrip strength of each volunteer using a hydraulic dynamometer. | Device | Hand strength |
Primary outcome
Force
Time frame: 15 minutes
The force of handgrip, pinch pulp-side and pinch pulp-pulp movement. The test was measured 3 times with 1 minute interval . Unit of measurement: kilogram - force (kgf).
3 secondary outcomes
Anthropometric variables (weight)
Time frame: 1 minute
Anthropometric variables (height)
Time frame: 1 minute
Anthropometric variables (Measurements of the hands)
Time frame: 3 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 15 Mar 2018.
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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 Electronic Dynamometer and Hydraulic dynamometer in people with Hand Strength, 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 4 inclusion and 1 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 15 Mar 2018. 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?
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 15 Mar 2018.