Trial Outcomes & Findings for Validation Study Of A Digital Measuring Device For Central Hand Representation In Children With A Neonatal Brachial Plexus Palsy (NCT NCT06950879)
NCT ID: NCT06950879
Last Updated: 2025-08-19
Results Overview
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.
COMPLETED
18 participants
Single session (approximately 45 minutes)
2025-08-19
Participant Flow
Participants were recruited between Januari and April 2025 at the Child Rehabilitation Centre of Ghent University Hospital. Eligible children with a confirmed diagnosis of neonatal brachial plexus palsy (NBPP) were identified during regular consultations at the multidisciplinary NBPP clinic. Information about the study was provided verbally and in writing to families. A total of 18 participants aged 8- 18 were included.
Participant milestones
| Measure |
Participants
A group of 18 children aged 8-18 with a neonatal brachial plexus palsy.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Participants
A group of 18 children aged 8-18 with a neonatal brachial plexus palsy.
|
|---|---|
|
Overall Study
Unable to complete task due to motor impairment
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participants
n=17 Participants
17 children aged 8-18 with a neonatal brachial plexus palsy.
|
|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Participants
n=17 Participants
A group of 17 children aged 8-18 with a neonatal brachial plexus palsy. We measured the implicit map of hand size 6 times for each hand.
|
|---|---|
|
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Left hand
|
0.91 Intraclass Correlation Coefficient
Interval 0.75 to 0.96
|
|
Intrarater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Right hand
|
0.92 Intraclass Correlation Coefficient
Interval 0.67 to 0.98
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Participants
n=17 Participants
A group of 17 children aged 8-18 with a neonatal brachial plexus palsy. We measured the implicit map of hand size 6 times for each hand.
|
|---|---|
|
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Left hand
|
0.72 Intraclass Correlation Coefficient
Interval 0.27 to 0.9
|
|
Interrater Reliability of Implicit Finger Length Estimates Using the HandUZ Device
Right hand
|
0.71 Intraclass Correlation Coefficient
Interval 0.36 to 0.88
|
Adverse Events
Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place