Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

L'influence de la latéralisation corticale sur le contrôle moteur sélectif du balancement du bras pendant la marche indépendante après un AVC.

16 septembre 2026 mis à jour par: University Hospital, Ghent

The upper limbs play an essential role for safe and efficient walking in healthy persons and persons post-stroke. Nevertheless, in current post-stroke gait rehabilitation (research) the upper limbs are barely targeted. To address this gap, my project aims to investigate the selective motor control of the upper limbs during walking and the contribution of the cortical activity to the arm swing in independent walkers after stroke.

To gain insight in the direct effects of stroke on the arm swing, the primary motor control of the arm swing will be evaluated by determining muscle synergies (i.e group of muscles working together as a task-specific functional unit). Additionally, the cortical activity (EEG-analysis) during walking of persons post-stroke will be compared to healthy controls and the relationship between stroke-induced changes in cortical activity and arm swing deviations will be assessed. Furthermore, I will evaluate whether improvements in cortical activity relate to improvements in primary motor control of the arm swing.

This innovative project will be the first to investigate the direct coupling between the cortex and the muscle synergies in persons post-stroke during independent walking to investigate the arm swing. These fundamental insights in the primary motor control of the arm swing and the contribution of the cortical activity will allow to develop targeted interventions aiming to improve arm swing and as such optimize post-stroke gait rehabilitation.

Research questions:

  1. How can muscle synergies explain arm swing alterations in independent walkers after stroke?
  2. How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
  3. Are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke?

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

84

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

      • Diepenbeek, Belgique, 3590
        • Recrutement
        • UHasselt - Faculteit Revalidatiewetenschappen
        • Contact:
        • Contact:
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgique
        • Recrutement
        • Ghent University Hospital
        • Chercheur principal:
          • Arne Defour, Msc.
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Stroke

Inclusion Criteria:

  • First-ever and cerebral stroke
  • Able to walk at least 10 minutes (FAC ≥ 3)
  • Presence of upper limb paresis (NIHSS item 5a/b > 0)

Exclusion Criteria:

  • Other neurological disorders

Healthy controls

Inclusion criteria:

  • Older than 18 years
  • Able to walk at least 10 minutes

Exlusion criteria:

  • Pregnancy

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Stroke

Persons with a unilateral first ever stroke

Participants have to walk without holding handrails and without bodyweight support for at least 200 gait cycles. They are asked to walk at comfortable walking speed while watching forward to a screen without virtual reality projection. Arm should be next to the body to allow arm swing if possible.

Comparateur actif: Control

Age and gender matched healthy controls

Participants have to walk without holding handrails and without bodyweight support for at least 200 gait cycles. They are asked to walk at comfortable walking speed while watching forward to a screen without virtual reality projection. Arm should be next to the body to allow arm swing if possible.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of muscle synergies
Délai: Single point of assessment at inclusion

The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors compared to healthy controls. Following muscles will be examined:

  • tibialis anterior,
  • gastrocnemius lateralis
  • soleus
  • vastus medialis
  • vastus lateralis
  • rectus femoris
  • biceps femoris
  • gluteus medius
  • erector spinae
  • latissimus dorsi
  • anterior deltoid
  • posterior deltoid
  • biceps brachii
  • triceps brachii
Single point of assessment at inclusion
Number of muscle synergies
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

The number of muscle synergies needed to account for 90% variance in muscle activity measured by surface EMG during walking in stroke survivors after a follow-up period of three months. Following muscles will be examined:

  • tibialis anterior,
  • gastrocnemius lateralis
  • soleus
  • vastus medialis
  • vastus lateralis
  • rectus femoris
  • biceps femoris
  • gluteus medius
  • erector spinae
  • latissimus dorsi
  • anterior deltoid
  • posterior deltoid
  • biceps brachii
  • triceps brachii
Single point of assessment 3 months after inclusion (only for stroke survivors)
Weight of muscle synergies
Délai: Single point of assessment at inclusion

The number or distribution of muscle weightings within a synergy during walking in stroke survivors compared to healthy controls.

The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:

  • tibialis anterior,
  • gastrocnemius lateralis
  • soleus
  • vastus medialis
  • vastus lateralis
  • rectus femoris
  • biceps femoris
  • gluteus medius
  • erector spinae
  • latissimus dorsi
  • anterior deltoid
  • posterior deltoid
  • biceps brachii
  • triceps brachii
Single point of assessment at inclusion
Weight of muscle synergies
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

The number or distribution of muscle weightings within a synergy during walking in stroke survivors after a follow-up period of three months.

The distribution of muscle activation averages over one gait cycle measured by surface EMG of following muscles:

  • tibialis anterior,
  • gastrocnemius lateralis
  • soleus
  • vastus medialis
  • vastus lateralis
  • rectus femoris
  • biceps femoris
  • gluteus medius
  • erector spinae
  • latissimus dorsi
  • anterior deltoid
  • posterior deltoid
  • biceps brachii
  • triceps brachii
Single point of assessment 3 months after inclusion (only for stroke survivors)
Brain symmetry index (BSI)
Délai: Single point of assessment at inclusion

The amount of cortical lateralization during walking in stroke survivors compared to healthy controls. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1.

Single point of assessment at inclusion
Brain symmetry index (BSI)
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

The amount of cortical lateralization during walking in stroke survivors after a follow-up period of three months. The score ranges from -1 to +1 with BSI = 0 reprenting perfect symmetry. Positive values represent higher power in the right hemishere compared to the left hemisphere, vice versa for negative values. For left side lesions, BSI was multiplied by -1.

Single point of assessment 3 months after inclusion (only for stroke survivors)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Upper limb kinematics
Délai: Single point of assessment at inclusion

Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)

Single point of assessment at inclusion
Upper limb kinematics
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)

Single point of assessment 3 months after inclusion (only for stroke survivors)
Cortico-synergy coherence
Délai: Single point of assessment at inclusion

The amount of coherence (i.e. phase locking) between the muscle synergies and cortical activity during walking in stroke survivors compared to healthy controls. Higher values (0-1) indicate a better linear association.

Single point of assessment at inclusion
Cortico-synergy coherence
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

The amount of coherence (i.e phase locking) between the muscle synergies and cortical activity during walking in stroke survivors after a follow-up period of three months. Higher values (0-1) indicate a better linear association.

Single point of assessment 3 months after inclusion (only for stroke survivors)

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
National Institutes of Health Stroke Scale (NIHSS)
Délai: Single point of assessment at inclusion (only for stroke survivors)

Quantifies the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42.

Single point of assessment at inclusion (only for stroke survivors)
National Institutes of Health Stroke Scale (NIHSS)
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Quantifies the general impairment caused by a stroke after a follow-up period of three months. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The highest score is 42.

Single point of assessment 3 months after inclusion (only for stroke survivors)
Fugl-Meyer assesment - Upper limbs
Délai: Single point of assessment at inclusion (only for stroke survivors)

Assesses specifc motor impairments of the upper limbs of stroke survivors. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.

Single point of assessment at inclusion (only for stroke survivors)
Fugl-Meyer assesment - Upper limbs
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Assesses specifc motor impairments of the upper limbs of stroke survivors after a follow-up period of three months. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.

Single point of assessment 3 months after inclusion (only for stroke survivors)
Tardieu scale
Délai: Single point of assessment at inclusion (only for stroke survivors)

Quantifies spasticity by assessing the muscle's response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2).

Single point of assessment at inclusion (only for stroke survivors)
Tardieu scale
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Quantifies spasticity by assessing the muscle's response (0-5) to different stretch velocities (V1, V2 or V3) and by determining the spasticity angle (R1 or R2).

Single point of assessment 3 months after inclusion (only for stroke survivors)
10 Meter Walking Test
Délai: Single point of assessment at inclusion (only for stroke survivors)

Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds).

Single point of assessment at inclusion (only for stroke survivors)
10 Meter Walking Test
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Examins the walking capacity of a stroke survivor by measuring how long it takes to walk a distance of 10 meters (in seconds).

Single point of assessment 3 months after inclusion (only for stroke survivors)
Fugl-Meyer assesment - Lower limbs
Délai: Single point of assessment at inclusion (only for stroke survivors)

Assesses specifc motor impairments of the lower limbs of stroke survivors. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.

Single point of assessment at inclusion (only for stroke survivors)
Fugl-Meyer assesment - Lower limbs
Délai: Single point of assessment 3 months after inclusion (only for stroke survivors)

Assesses specifc motor impairments of the lower limbs of stroke survivors after a follow-up period of three months. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. However, reflex activity is measured using 2 points only, with a score of 0 or 2 for absence and presence of reflex respectively.

Single point of assessment 3 months after inclusion (only for stroke survivors)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

9 juillet 2024

Achèvement primaire (Estimé)

30 décembre 2026

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

29 mai 2024

Première soumission répondant aux critères de contrôle qualité

29 mai 2024

Première publication (Réel)

4 juin 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

16 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • ONZ-2024-0089
  • 11PEU24N (Autre subvention/numéro de financement: FWO)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner