NCT04376372

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2021

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

5.3 years

First QC Date

April 15, 2020

Last Update Submit

January 5, 2023

Conditions

Neonatal Brachial Plexus Palsy

Keywords

upper limb paresisdevelopmentalfunctiona laterality

Outcome Measures

Primary Outcomes (8)

  • Strength-1

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

    Baseline

  • Strength-2

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

    Baseline

  • Strength-3

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

    Baseline

  • Sensibility hand

    Semmes-Weinstein monofilament ( normal- abnormal)

    Baseline

  • Handedness

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

    Baseline

  • Baseline measure : brain imaging

    Magnetic resonance imaging (MRI)

    Baseline

  • Baseline measure : movement pattern

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

    Baseline

  • Body representation

    actual, implicit hand representation by drawings : mm

    Baseline

Secondary Outcomes (11)

  • quality of life-1

    Baseline

  • quality of life-2

    Baseline

  • Activity-1

    Baseline

  • Activity-2

    Baseline

  • Activity-3

    Baseline

  • +6 more secondary outcomes

Study Arms (2)

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

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

Diagnostic Test: Functional testing, Magnetic resonance imaging, Electromyography

Interventions

Functional testing, Magnetic resonance imaging, ElectromyographyDIAGNOSTIC_TEST

Electromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders)

F_lefthandersTD_lefthanders

Eligibility Criteria

Age6 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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

You may qualify if:

  • typical developing
  • lefthanded
  • NBPP or healthy
  • righthanded parents
  • years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Medicine and Rehabilitation

Ghent, Oost Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Neonatal Brachial Plexus PalsyParesis

Interventions

Magnetic Resonance ImagingElectromyography

Condition Hierarchy (Ancestors)

Brachial Plexus NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesBirth InjuriesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisMyography

Study Officials

  • Ruth Van der Looven, MD

    Physical Medicine and Rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

May 6, 2020

Study Start

May 1, 2016

Primary Completion

August 17, 2021

Study Completion

August 17, 2021

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations

BE(1)