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

NCT06950879 | Completed Results

• 1 other identifier: ONZ-2024-0515
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Single session (approximately 45 minutes)

Secondary Outcomes (1)

• Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device

  Single session (approximately 45 minutes)

Study Arms (1)

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

Interventions

Measurement 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

Participants

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Presence of a Neonatal Brachial Plexus Palsy

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 34405401 BACKGROUND

MeSH Terms

Conditions

Neonatal Brachial Plexus Palsy

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Brachial Plexus Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Birth Injuries; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Ruth Van der Looven
• Organization: Ghent University

ruth.Vanderlooven@uzgent.be

003293324237

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 30, 2025
• Study Start: January 25, 2025
• Primary Completion: April 10, 2025
• Study Completion: May 1, 2025
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)