Validation Study Of A Digital Measuring Device For Central Hand Representation In Children With A Neonatal Brachial Plexus Palsy

July 31, 2025 updated by: University Hospital, Ghent

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children between the age of 8 and 18 with a Neonatal Brachial Plexus Palsy

Description

Inclusion Criteria:

  • Presence of a Neonatal Brachial Plexus Palsy

Exclusion Criteria:

  • Presence of any other important locomotor, neurological or psychiatric disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Measurement

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single session (approximately 45 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Time Frame: Single session (approximately 45 minutes)
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
Single session (approximately 45 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2025

Primary Completion (Actual)

April 10, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

July 31, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2024-0515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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