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Clinical Trials/NCT04376372
NCT04376372CompletedNot Applicable

Forced Lefthandedness in Neonatal Brachial Plexus Palsy (NBPP) Children : is There a Neurophysiological and Functional Difference With Natural Lefthanders

University Hospital, Ghent1 site in 1 country82 target enrollmentStarted: May 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
82
Locations
1
Primary Endpoint
Sensibility hand

Study Overview

Brief 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).

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

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
6 Years to 23 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • typical developing
  • lefthanded
  • NBPP or healthy
  • righthanded parents
  • 6-23 years

Exclusion Criteria

  • history of other locomotor or neurological disorder than NBPP
  • history of brain surgery
  • history of psychiatric disorder

Outcomes

Primary Outcomes

Sensibility hand

Time Frame: Baseline

Semmes-Weinstein monofilament ( normal- abnormal)

Baseline measure : brain imaging

Time Frame: Baseline

Magnetic resonance imaging (MRI)

Strength-3

Time Frame: Baseline

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

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

Handedness

Time Frame: Baseline

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

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

Secondary Outcomes

  • Function( for cases)(Baseline)
  • muscle and nerve function(baseline)
  • Activity-1(Baseline)
  • quality of life-1(Baseline)
  • quality of life-2(Baseline)
  • cognition(baseline)
  • Activity-2(Baseline)
  • Activity-4(Baseline)
  • Activity-3(Baseline)
  • shoulder function cases(Baseline)
  • writing(baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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