Physical Medicine and Rehabilitation
Ghent, Oost Vlaanderen, 9000, Belgium
NCT Number: NCT04376372
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).
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Notify Me6 year–23 year
All sexes
Observational
Ghent, Oost Vlaanderen, 9000, Belgium
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Electromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders)
Time frame: Baseline
Medical Research Council Scale (MRC-scale) : score 0-5 ; 0 : no muscle contraction (worse) to 5 : normal power (better)
Time frame: Baseline
Grip Strength (E-link) : Percent of the norm : higher = better
Time frame: Baseline
Active Movement scale (AMS): score 0-7 ; 0: no contraction to 7 : full motion
Time frame: Baseline
Semmes-Weinstein monofilament ( normal- abnormal)
Time frame: Baseline
Edinburgh Handedness Inventory (EDI) : Lateralization index: -100 (pure lefthander) to +100 (pure righthander)
Time frame: Baseline
Magnetic resonance imaging (MRI)
Time frame: Baseline
Kinematic movement analysis (kinematic angels, kinetic forces, movement patterns)
Time frame: Baseline
actual, implicit hand representation by drawings : mm
Time frame: Baseline
the Pediatric Outcome Data Collecting Instrument - dutch version
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Baseline
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.
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: baseline
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).
Time frame: baseline
electromyography (EMG)
Time frame: baseline
Vlaamse schrijftest : norms per age
University Hospital, Ghent
Other
Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children : is There a Neurophysiological and Functional Difference With Natural Lefthanders
Acronym: NBPP
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