Neonatal Brachial Plexus PalsyNBPPNCT04376372
Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children
An observational study of Neonatal Brachial Plexus Palsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The aim of the project is to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP). Read more about this study
- Who is it for?
- Ages 6 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Brachial Plexus Palsy
- What is being tested?
- Functional testing, Magnetic resonance imaging, Electromyography
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2016to 17 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Group 1 : healthy lefthanded typical developing children and adolescents with righthanded parents Group 2 : Forced lefthanded NBPP children and adolescents with righthanded parents
Who may be able to join
- typical developing
- lefthanded
- NBPP or healthy
- righthanded parents
- 6-23 years
Who cannot join
- history of other locomotor or neurological disorder than NBPP
- history of brain surgery
- history of psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Physical Medicine and Rehabilitation
Ghent, Oost Vlaanderen, 9000
About this study
Official title: Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children : is There a Neurophysiological and Functional Difference With Natural Lefthanders
The aim of the project is to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP).
Read the detailed description
A cross-sectional case-control study design to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP). Controls are natural lefthanded typical developing children and adolescents.Case and controls are matched for age, gender and activity level.
- Conditions
- Neonatal Brachial Plexus Palsy
- Being tested
- Functional testing, Magnetic resonance imaging, Electromyography
- Keywords
- upper limb paresis, developmental, functiona laterality
- Medical subject headings
- Neonatal Brachial Plexus Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional testing, Magnetic resonance imaging, ElectromyographyDiagnostic test
Electromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders)
| Study group | Role | What they receive |
|---|---|---|
| TD_lefthanders | Typical developing lefthanded children and adolescents Assessment : sensibility, strength,writing,manual dexterity,degree of lefthandedness, body representation, movement analysis, motor control, quality of life, participation Receives: Diagnostic Test: Functional testing, Magnetic resonance imaging, Electromyography | |
| F_lefthanders | Forced left handed NBPP children Assessment : sensibility, strength,writing,manual dexterity,degree of lefthandedness, body representation, movement analysis, motor control, quality of life, participation Receives: Diagnostic Test: Functional testing, Magnetic resonance imaging, Electromyography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength-1
Medical Research Council Scale (MRC-scale) : score 0-5 ; 0 : no muscle contraction (worse) to 5 : normal power (better)
Measured: Baseline
Strength-2
Grip Strength (E-link) : Percent of the norm : higher = better
Measured: Baseline
Strength-3
Active Movement scale (AMS): score 0-7 ; 0: no contraction to 7 : full motion
Measured: Baseline
Sensibility hand
Semmes-Weinstein monofilament ( normal- abnormal)
Measured: Baseline
Handedness
Edinburgh Handedness Inventory (EDI) : Lateralization index: -100 (pure lefthander) to +100 (pure righthander)
Measured: Baseline
Baseline measure : brain imaging
Magnetic resonance imaging (MRI)
Measured: Baseline
Baseline measure : movement pattern
Kinematic movement analysis (kinematic angels, kinetic forces, movement patterns)
Measured: Baseline
Body representation
actual, implicit hand representation by drawings : mm
Measured: Baseline
Secondary outcomes (11)
quality of life-1
the Pediatric Outcome Data Collecting Instrument - dutch version
- The PODCI consists of 5 domains: Upper Extremity and Physical Function, Transfers and Basic Mobility, Sports and Physical Functioning, Pain/Comfort, and Happiness. The "Global Functioning Score" is a mean of all domains except Happiness. The PODCI divides the ages into 2 groups: ages 2 to 10 years, which is filled out by the parent/guardian only, and ages 11 to 18 years, which has a questionnaire to be filled out by both the parents/guardians and the child. A raw score is created both for each domain and for the Global score, and can be compared with a normative standard
Measured: Baseline
quality of life-2
KIDSCREEN-52- dutch version : questionnaire of 52 items to be answered by the child/adolescent assessing Health related Quality of Life. • The KIDSCREEN items use 5-point Likert-type scale. Rasch scores are computed for each dimension and transformed into T-values with a mean of 50 and a standard deviation of 10; higher scores indicate better HRQoL and well-being.KIDSCREEN-52 T scores refer to the mean values and standard deviations from a multinational European sample
Measured: Baseline
Activity-1
The Children's Hand-use Experience Questionnaire (CHEQ) is an online questionnaire for children from 6 to 18 years with unilateral upper limb impairment. It is designed to measure children's own experiences when using the affected hand in common daily life activities requiring use of both hands.For children below the age of 13 years, it is recommended that parents act as proxy. CHEQ is a computer-adaptive online questionnaire consisting of 29 items; available free of charge via the website (www.cheq.se). Three scales are used to measure the grasp efficacy when both hands are involved, time utilization when performing the activity compared with peers, and experience of feeling bothered while performing the activities independently. CHEQ scales are rated on a four-point ordinal scale and raw scores can be transformed by Rasch analysis to logits and further into a 0-100 CHEQ-units;Higher scores indicate a better grasp, less time taken, and greater satisfaction.
Measured: Baseline
Activity-2
Assisting Hand assessments (AHA). The AHA is used to score object-related hand actions observed during a semi-structured test situation (10-20min) that elicits the use of both hands and which is suitable for different age groups.A transformation table of raw scores to interval-level 'AHA units' is available. (0-100). The higher the score the more the hand is properly used as assisted hand
Measured: Baseline
Activity-3
The Melbourne Assessment is based on 16 items comprising tasks that are representative of the most important components of unilateral upper limb function (reach, grasp, release, and manipulate). Most items are further subdivided in two to four sub-items that represent an aspect of the required movement, such as range of movement, fluency, target accuracy, speed, and quality of movement. The total score can range from 0 to 122 points and can be converted to a percentage. The higher the score, the better the unilateral limb function
Measured: Baseline
Activity-4
The Purdue Pegboard Test is designed to assess fine motor hand function. This assessment involves a series of four subtests that consist of placing small pins into holes on a pegboard and assembling pins and washers. The subsets for preferred, non-preferred, and both hands require the patient to place the pins in the holes as quickly as possible, with the score being the number of pins placed in 30 s. Aged normed data are available.
Measured: Baseline
shoulder function cases
mallet scale of shoulder function : 8 items. In the Mallet score, shoulder movements are graded on a scale from 1 (no motion) to 5 (normal motion equal to that in the unaffected side), resulting in a maximum total score of 40. A Mallet subscore of 4 or better is considered to be good shoulder function
Measured: Baseline
Function( for cases)
Brachial plexus outcome measure (BPOM) :The BPOM is a, disease-specific, functional upper extremity assessment for children with NBPP. It has 2 subscales: Activity and Self-evaluation. The BPOM Activity subscale has 11 items, and each item is scored between 1 and 5 on an ordinal scale. A score of1 indicates that the task cannot be completed, and a score of 5 indicates that the task can be completed with normal movement pattern. The Activity subscale contains 3 parts: (1) shoulder, (2) elbow and forearm, and (3) wrist, finger, and thumb. The BPOM Self-evaluation subscale consists of 2 visual analog scales to evaluate the working of the arm and hand and 1 visual analog scale to evaluate the appearance of the arm and hand of the child. Several categories and items are evaluated simultaneously, and each score is calculated separately to define the function
Measured: Baseline
cognition
Wechsler intelligence Scale for children: a short form consisting of subtests : (picture completion (PC), Vocabulary (V), Block Design (BD) and Similarities (S))of the WISC-III to estimate participant's intelligence.
The subtest scores of the short form were transformed into deviation IQs (DIQ), based on mean intercorrelations from the standardization sample (Wechsler, 1991).
- Classification : volgens DIQ
- < of = 89 : below average
- 90 of = 109 : average
- 110 of > : above average
Measured: baseline
muscle and nerve function
electromyography (EMG)
Measured: baseline
writing
Vlaamse schrijftest : norms per age
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 May 2016
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Brachial Plexus PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Van der Looven, MD, Principal investigator, Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376372
- Sponsor's protocol ID
- B670201525721
- Acronym
- NBPP
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2020
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children : is There a Neurophysiological and Functional Difference With Natural Lefthanders
- ClinicalTrials.gov ID
- NCT04376372
- Acronym / sponsor ID
- NBPP / B670201525721
- Conditions
- Neonatal Brachial Plexus Palsy
- Keywords
- upper limb paresis, developmental, functiona laterality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the project is to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP).
Detailed description
A cross-sectional case-control study design to assess the neurophysiological and functional consequences of forced lefthandedness in a population with right neonatal brachial plexus palsy (NBPP). Controls are natural lefthanded typical developing children and adolescents.Case and controls are matched for age, gender and activity level.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TD_lefthanders | – | Diagnostic Test: Functional testing, Magnetic resonance imaging, ElectromyographyTypical developing lefthanded children and adolescents Assessment : sensibility, strength,writing,manual dexterity,degree of lefthandedness, body representation, movement analysis, motor control, quality of life, participation |
| F_lefthanders | – | Diagnostic Test: Functional testing, Magnetic resonance imaging, ElectromyographyForced left handed NBPP children Assessment : sensibility, strength,writing,manual dexterity,degree of lefthandedness, body representation, movement analysis, motor control, quality of life, participation |
Who may qualify
- Ages
- 6 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Group 1 : healthy lefthanded typical developing children and adolescents with righthanded parents Group 2 : Forced lefthanded NBPP children and adolescents with righthanded parents
Key inclusion criteria (5 listed)
- typical developing
- lefthanded
- NBPP or healthy
- righthanded parents
- 6-23 years
Key exclusion criteria (3 listed)
- history of other locomotor or neurological disorder than NBPP
- history of brain surgery
- history of 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 |
|---|---|---|
| Functional testing, Magnetic resonance imaging, ElectromyographyElectromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders) | Diagnostic test | F_lefthanders, TD_lefthanders |
Primary outcome
Strength-1
Time frame: Baseline
Medical Research Council Scale (MRC-scale) : score 0-5 ; 0 : no muscle contraction (worse) to 5 : normal power (better)
Strength-2
Time frame: Baseline
Grip Strength (E-link) : Percent of the norm : higher = better
Strength-3
Time frame: Baseline
Active Movement scale (AMS): score 0-7 ; 0: no contraction to 7 : full motion
Sensibility hand
Time frame: Baseline
Semmes-Weinstein monofilament ( normal- abnormal)
Handedness
Time frame: Baseline
Edinburgh Handedness Inventory (EDI) : Lateralization index: -100 (pure lefthander) to +100 (pure righthander)
Baseline measure : brain imaging
Time frame: Baseline
Magnetic resonance imaging (MRI)
Baseline measure : movement pattern
Time frame: Baseline
Kinematic movement analysis (kinematic angels, kinetic forces, movement patterns)
Body representation
Time frame: Baseline
actual, implicit hand representation by drawings : mm
11 secondary outcomes
quality of life-1
Time frame: Baseline
quality of life-2
Time frame: Baseline
Activity-1
Time frame: Baseline
Activity-2
Time frame: Baseline
Activity-3
Time frame: Baseline
Activity-4
Time frame: Baseline
shoulder function cases
Time frame: Baseline
Function( for cases)
Time frame: Baseline
cognition
Time frame: baseline
muscle and nerve function
Time frame: baseline
writing
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
Related trials for Neonatal Brachial Plexus Palsy
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy
RecruitingPhase 3
Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy
Obstetrical Brachial Plexus Palsy
Not yet recruitingObservational study
Kinematic Analysis of Latissimus Dorsi Transfer Results for Shoulder External Rotation Resuscitation
Osbtetric Brachial Plexus Palsy
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.
Ruth Van der Looven, MD principal investigator
Physical Medicine and Rehabilitation
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 5 inclusion and 3 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 9 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Strength-1 (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2023.