ChildrenNCT04024592
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
A study testing Biodex System 4 in people with Children and Muscle Strength, run by University Ghent at 1 site in Belgium.
Trial summary
Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Muscle Strength, Reproducibility of Results
- What is being tested?
- Biodex System 4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Nov 2017to 30 Apr 2018
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children with good intellectual capacities
Who cannot join
- children with chronic disease or intellectual deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.
Read the detailed description
Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.
Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.
- Being tested
- Biodex System 4
- Keywords
- child, dynamometry, knee joint, reproducability of results, strength testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex System 4Device
Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.
| Study group | Role | What they receive |
|---|---|---|
| children | Experimental | Not described Receives: Device: Biodex System 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic strength assessment with Biodex System 4 device
Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements)
Measured: 90 minutes
Secondary outcomes (1)
Functional strength assessment
30 second tests (number of trials in 30 seconds)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start30 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Van den Broeck, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024592
- Sponsor's protocol ID
- B670201834766
- Status last verified
- Jul 2019
- First submitted
- 24 Jan 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
- ClinicalTrials.gov ID
- NCT04024592
- Acronym / sponsor ID
- B670201834766
- Keywords
- child, dynamometry, knee joint, reproducability of results, strength testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 18 Jul 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.
Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.
Detailed description
Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.
Children will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | Experimental | Device: Biodex System 4 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children with good intellectual capacities
Key exclusion criteria (1 listed)
- children with chronic disease or intellectual deficiency
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 |
|---|---|---|
| Biodex System 4Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children. | Device | children |
Primary outcome
Isokinetic strength assessment with Biodex System 4 device
Time frame: 90 minutes
Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements)
1 secondary outcome
Functional strength assessment
Time frame: 30 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 18 Jul 2019.
- 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.
Christine Van den Broeck, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex System 4 in people with Children and Muscle Strength, run by University Ghent at 1 site in Belgium.
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 1 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 18 Jul 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 Belgium. 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?
Isokinetic strength assessment with Biodex System 4 device (time frame: 90 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 18 Jul 2019.