Neonatal Brachial Plexus PalsyNCT06950879
Validation Study Of A Digital Measuring Device For Central Hand Representation In Children With A Neonatal Brachial Plexus Palsy
An observational study of Neonatal Brachial Plexus Palsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Hand function is one of the most complex and sophisticated sensorimotor skills, controlled by the interplay of precise motor efferent and multisensory afferent stimuli. A coherent central representation of the hand is essential for performing hand movements in a changing environment. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Neonatal Brachial Plexus Palsy
- What is being tested?
- Measurement
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jan 2025to 1 May 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children between the age of 8 and 18 with a Neonatal Brachial Plexus Palsy
Who may be able to join
- Presence of a Neonatal Brachial Plexus Palsy
Who cannot join
- Presence of any other important locomotor, neurological or psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implicit Central Hand Representation in Children With Neonatal Brachial Plexus Palsy: Interrater and Intrarater Reliability of the HandUZ Device - A Validation Study
Hand function is one of the most complex and sophisticated sensorimotor skills, controlled by the interplay of precise motor efferent and multisensory afferent stimuli. A coherent central representation of the hand is essential for performing hand movements in a changing environment.
However, the hand representation in the brain consists of many modalities (visual, proprioceptive, anthropometric,...). The division between explicit (conscious) and implicit (unconscious) representation of the hand is accepted by a large group of researchers. The explicit representation of the hand is based partly on visual afferents, the implicit on all other afferent inputs.
Read more
Impaired hand function in everyday use after injury may be due to aberrant hand representation. Previous research showed that children with neonatal brachial plexus injury have impaired implicit hand representation with respect to hand size. Despite the good reproducibility of test results reported in the literature, the measurement method is very cumbersome.
In the current technological revolution, digitalisation of the device is the ideal solution to make the measurement method clinically applicable in daily practice.
Therefore, a new prototype digital device has been developed to automate the measurement method. This prototype works on the same principle and has the same dimensions as previous studies. It includes digital storage and processing of the measurement results. This study investigates the reproducibility (inter- and intra-observer) of the digital prototype.
The study will recruit children aged between 8 and 18 years with a neonatal brachial plexus injury.
Doctors treating this patient group will explain the study during consultations and provide a flyer. Participation in the study means that the patient will be invited to the UZ Ghent Paediatric Rehabilitation Centre, where two different doctors will independently perform the measurement. Specifically, they will be asked to place their hand on a mat and the fingertips, knuckles and wrist will be marked on the device. A wooden board is then placed over the hand so that the hand is no longer visible. The subject is then asked to indicate the fingertips, knuckles and wrist in random order, again recorded on the device. The test takes 5 to a maximum of 10 minutes (depending on cooperation). This measurement is repeated a 6 times on each hand.
Based on these measurements, the device calculates the average of each participant's perceived hand width and finger length. These values are compared with the actual hand width and finger length. This allows us to calculate a percentage of overestimation. Studies using such data have already been published.
The aim of this study is to measure the reproducibility (inter- and intraobserver) of the digitised version.
- Conditions
- Neonatal Brachial Plexus Palsy
- Being tested
- Measurement
- Medical subject headings
- Neonatal Brachial Plexus Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeasurementOther
A wooden construction was built consisting of two plates with dimensions of 35 x 29 cm: a bottom plate, with a measuring mat glued to it, a movable middle plate and a smaller top plate, allowing to mount a standardized overhead camera.
Participants were seated and placed one hand palm down on the measuring mat on the bottom plate. The hand was aligned with the midline of the body, lay flat with the fingers straight and lightly spread. First the actual landmarks were marked on the computer. Subsequently the participants hand was occluded by adding the middle plate. Participants were verbally cued to mark a certain landmark with their contralateral hand. These indicated points were marked on the computer. Before and after each trial, a picture was taken without the occluding board to ensure that the hand had not moved from its original position by digitally overlaying the images
| Study group | Role | What they receive |
|---|---|---|
| Participants | A group of 20 children aged 8-18 with a neonatal brachial plexus palsy. We measured the implicit map of hand size 6 times for each hand. Receives: Other: Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Intrarater reliability was assessed using the intraclass correlation coefficient (ICC[3,1]) based on two sets of averaged finger length estimates (FL) per participant, measured across two time points by the same rater. FL was calculated in centimeters as the Euclidean distance between the fingertip and metacarpophalangeal (MCP) joint for each digit. Data were averaged across fingers and hands to yield a single participant-level value. ICCs were calculated using a two-way mixed-effects model, absolute agreement. A higher ICC indicates greater measurement reliability. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows.
Measured: Single session (approximately 45 minutes)
Secondary outcomes (1)
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Interrater reliability was assessed using the intraclass correlation coefficient (ICC[3,1]) based on two sets of averaged finger length estimates (FL) measured independently by two trained raters. FL was computed per finger (in cm) as the Euclidean distance between fingertip and MCP joint using HandUZ software. Values were averaged across fingers and hands. ICCs were calculated using a two-way mixed-effects model, absolute agreement. Separate ICC values are provided for the left and right hands in the results table, but both are reported under this single outcome measure. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows
Measured: Single session (approximately 45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start25 Jan 2025
- Primary completion10 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Brachial Plexus PalsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950879
- Sponsor's protocol ID
- ONZ-2024-0515
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2025
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van der Looven R, Hermans L, Coupe AM, De Muynck M, Vingerhoets G. Neonatal brachial plexus palsy and hand representation in children and young adults. Dev Med Child Neurol. 2022 Feb;64(2):183-191. doi: 10.1111/dmcn.15008. Epub 2021 Aug 17.
PubMed 34405401
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implicit Central Hand Representation in Children With Neonatal Brachial Plexus Palsy: Interrater and Intrarater Reliability of the HandUZ Device - A Validation Study
- ClinicalTrials.gov ID
- NCT06950879
- Acronym / sponsor ID
- ONZ-2024-0515
- Conditions
- Neonatal Brachial Plexus Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hand function is one of the most complex and sophisticated sensorimotor skills, controlled by the interplay of precise motor efferent and multisensory afferent stimuli. A coherent central representation of the hand is essential for performing hand movements in a changing environment.
However, the hand representation in the brain consists of many modalities (visual, proprioceptive, anthropometric,...). The division between explicit (conscious) and implicit (unconscious) representation of the hand is accepted by a large group of researchers. The explicit representation of the hand is based partly on visual afferents, the implicit on all other afferent inputs.
Impaired hand function in everyday use after injury may be due to aberrant hand representation. Previous research showed that children with neonatal brachial plexus injury have impaired implicit hand representation with respect to hand size. Despite the good reproducibility of test results reported in the literature, the measurement method is very cumbersome.
In the current technological revolution, digitalisation of the device is the ideal solution to make the measurement method clinically applicable in daily practice.
Therefore, a new prototype digital device has been developed to automate the measurement method. This prototype works on the same principle and has the same dimensions as previous studies. It includes digital storage and processing of the measurement results. This study investigates the reproducibility (inter- and intra-observer) of the digital prototype.
The study will recruit children aged between 8 and 18 years with a neonatal brachial plexus injury.
Doctors treating this patient group will explain the study during consultations and provide a flyer. Participation in the study means that the patient will be invited to the UZ Ghent Paediatric Rehabilitation Centre, where two different doctors will independently perform the measurement. Specifically, they will be asked to place their hand on a mat and the fingertips, knuckles and wrist will be marked on the device. A wooden board is then placed over the hand so that the hand is no longer visible. The subject is then asked to indicate the fingertips, knuckles and wrist in random order, again recorded on the device. The test takes 5 to a maximum of 10 minutes (depending on cooperation). This measurement is repeated a 6 times on each hand.
Based on these measurements, the device calculates the average of each participant's perceived hand width and finger length. These values are compared with the actual hand width and finger length. This allows us to calculate a percentage of overestimation. Studies using such data have already been published.
The aim of this study is to measure the reproducibility (inter- and intraobserver) of the digitised version.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Other: MeasurementA group of 20 children aged 8-18 with a neonatal brachial plexus palsy. We measured the implicit map of hand size 6 times for each hand. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children between the age of 8 and 18 with a Neonatal Brachial Plexus Palsy
Key inclusion criteria (1 listed)
- Presence of a Neonatal Brachial Plexus Palsy
Key exclusion criteria (1 listed)
- Presence of any other important locomotor, neurological or psychiatric disorder
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 |
|---|---|---|
| MeasurementA wooden construction was built consisting of two plates with dimensions of 35 x 29 cm: a bottom plate, with a measuring mat glued to it, a movable middle plate and a smaller top plate, allowing to mount a standardized overhead camera. Participants were seated and placed one hand palm down on the measuring mat on the bottom plate. The hand was aligned with the midline of the body, lay flat with the fingers straight and lightly spread. First the actual landmarks were marked on the computer. Subsequently the participants hand was occluded by adding the middle plate. Participants were verbally cued to mark a certain landmark with their contralateral hand. These indicated points were marked on the computer. Before and after each trial, a picture was taken without the occluding board to ensure that the hand had not moved from its original position by digitally overlaying the images | Other | Participants |
Primary outcome
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Time frame: Single session (approximately 45 minutes)
Intrarater reliability was assessed using the intraclass correlation coefficient (ICC[3,1]) based on two sets of averaged finger length estimates (FL) per participant, measured across two time points by the same rater. FL was calculated in centimeters as the Euclidean distance between the fingertip and metacarpophalangeal (MCP) joint for each digit. Data were averaged across fingers and hands to yield a single participant-level value. ICCs were calculated using a two-way mixed-effects model, absolute agreement. A higher ICC indicates greater measurement reliability. Each participant contributed two independent values (left and right hand), but the unit of analysis is the participant. Results for both hands are reported in separate rows.
1 secondary outcome
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Time frame: Single session (approximately 45 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34405401Van der Looven R, Hermans L, Coupe AM, De Muynck M, Vingerhoets G. Neonatal brachial plexus palsy and hand representation in children and young adults. Dev Med Child Neurol. 2022 Feb;64(2):183-191. doi: 10.1111/dmcn.15008. Epub 2021 Aug 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Brachial Plexus Palsy, run by University Hospital, 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 19 Aug 2025. 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?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device (time frame: Single session (approximately 45 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06950879, which also lists 1 linked publication.
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 19 Aug 2025.