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Der Einfluss der kortikalen Lateralisierung auf die selektive motorische Kontrolle des Armschwungs beim unabhängigen Gehen nach einem Schlaganfall.

16. September 2026 aktualisiert von: 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?

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

84

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Diepenbeek, Belgien, 3590
        • Rekrutierung
        • UHasselt - Faculteit Revalidatiewetenschappen
        • Kontakt:
        • Kontakt:
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgien
        • Rekrutierung
        • Ghent University Hospital
        • Hauptermittler:
          • Arne Defour, Msc.
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.

Aktiver Komparator: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of muscle synergies
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Upper limb kinematics
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
National Institutes of Health Stroke Scale (NIHSS)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Juli 2024

Primärer Abschluss (Geschätzt)

30. Dezember 2026

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2024

Zuerst gepostet (Tatsächlich)

4. Juni 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • ONZ-2024-0089
  • 11PEU24N (Andere Zuschuss-/Finanzierungsnummer: FWO)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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