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

NCT ID: NCT06950879

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-05-01

Brief 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.

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.

Conditions

Neonatal Brachial Plexus Palsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Measurement

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Presence of a Neonatal Brachial Plexus Palsy

Exclusion Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 34405401 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ONZ-2024-0515

Identifier Type: -

Identifier Source: org_study_id