Wpływ lateralizacji korowej na selektywną kontrolę motoryczną ruchu ramienia podczas samodzielnego chodzenia po udarze.
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:
- How can muscle synergies explain arm swing alterations in independent walkers after stroke?
- How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
- 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
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: Anke Van Bladel, PhD
- Numer telefonu: 09 332 12 43
- E-mail: Anke.VanBladel@UGent.be
Kopia zapasowa kontaktu do badania
- Nazwa: Arne Defour, Msc.
- Numer telefonu: 09 332 12 43
- E-mail: Arne.Defour@UGent.be
Lokalizacje studiów
-
-
-
Diepenbeek, Belgia, 3590
- Rekrutacyjny
- UHasselt - Faculteit Revalidatiewetenschappen
-
Kontakt:
- Arne Defour
- Numer telefonu: 093321243
- E-mail: arne.defour@ugent.be
-
Kontakt:
- Sophie De Mits
- Numer telefonu: 093321243
- E-mail: Sophie.DeMits@UGent.be
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgia
- Rekrutacyjny
- Ghent University Hospital
-
Główny śledczy:
- Arne Defour, Msc.
-
Kontakt:
- Anke Van Bladel, PhD
- Numer telefonu: 093321243
- E-mail: Sophie.DeMits@UGent.be
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
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
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / 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
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:
|
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:
|
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:
|
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:
|
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
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
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
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
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
Bada produkt urządzenia regulowany przez amerykańską FDA
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 .