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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Belgium

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.

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 groups in NCT04376372
Study groupRoleWhat they receive
TD_lefthandersTypical 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_lefthandersForced 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.

  1. Strength-1

    Medical Research Council Scale (MRC-scale) : score 0-5 ; 0 : no muscle contraction (worse) to 5 : normal power (better)

    Measured: Baseline

  2. Strength-2

    Grip Strength (E-link) : Percent of the norm : higher = better

    Measured: Baseline

  3. Strength-3

    Active Movement scale (AMS): score 0-7 ; 0: no contraction to 7 : full motion

    Measured: Baseline

  4. Sensibility hand

    Semmes-Weinstein monofilament ( normal- abnormal)

    Measured: Baseline

  5. Handedness

    Edinburgh Handedness Inventory (EDI) : Lateralization index: -100 (pure lefthander) to +100 (pure righthander)

    Measured: Baseline

  6. Baseline measure : brain imaging

    Magnetic resonance imaging (MRI)

    Measured: Baseline

  7. Baseline measure : movement pattern

    Kinematic movement analysis (kinematic angels, kinetic forces, movement patterns)

    Measured: Baseline

  8. Body representation

    actual, implicit hand representation by drawings : mm

    Measured: Baseline

Secondary outcomes (11)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. muscle and nerve function

    electromyography (EMG)

    Measured: baseline

  11. 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.

  1. First posted6 May 2020
  2. Study start1 May 2016
  3. Primary completion17 Aug 2021
  4. Study completion17 Aug 2021

Resources

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)
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

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.

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