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Wpływ lateralizacji korowej na selektywną kontrolę motoryczną ruchu ramienia podczas samodzielnego chodzenia po udarze.

16 września 2026 zaktualizowane przez: 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?

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

84

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

      • Diepenbeek, Belgia, 3590
        • Rekrutacyjny
        • UHasselt - Faculteit Revalidatiewetenschappen
        • Kontakt:
        • Kontakt:
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgia
        • Rekrutacyjny
        • Ghent University Hospital
        • Główny śledczy:
          • Arne Defour, Msc.
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 70 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.

Aktywny 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of muscle synergies
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Upper limb kinematics
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
National Institutes of Health Stroke Scale (NIHSS)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

9 lipca 2024

Zakończenie podstawowe (Szacowany)

30 grudnia 2026

Ukończenie studiów (Szacowany)

30 września 2027

Daty rejestracji na studia

Pierwszy przesłany

29 maja 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

29 maja 2024

Pierwszy wysłany (Rzeczywisty)

4 czerwca 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • ONZ-2024-0089
  • 11PEU24N (Inny numer grantu/finansowania: FWO)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .