- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT06442579
De invloed van corticale lateralisatie op de selectieve motorische controle van de armzwaai tijdens zelfstandig lopen na een beroerte.
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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Anke Van Bladel, PhD
- Telefoonnummer: 09 332 12 43
- E-mail: Anke.VanBladel@UGent.be
Studie Contact Back-up
- Naam: Arne Defour, Msc.
- Telefoonnummer: 09 332 12 43
- E-mail: Arne.Defour@UGent.be
Studie Locaties
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Diepenbeek, België, 3590
- Werving
- UHasselt - Faculteit Revalidatiewetenschappen
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Contact:
- Arne Defour
- Telefoonnummer: 093321243
- E-mail: arne.defour@ugent.be
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Contact:
- Sophie De Mits
- Telefoonnummer: 093321243
- E-mail: Sophie.DeMits@UGent.be
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, België
- Werving
- Ghent University Hospital
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Hoofdonderzoeker:
- Arne Defour, Msc.
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Contact:
- Anke Van Bladel, PhD
- Telefoonnummer: 093321243
- E-mail: Sophie.DeMits@UGent.be
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
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Actieve vergelijker: 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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of muscle synergies
Tijdsspanne: 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
Tijdsspanne: 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)
|
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Weight of muscle synergies
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Upper limb kinematics
Tijdsspanne: 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
Tijdsspanne: 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)
|
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Cortico-synergy coherence
Tijdsspanne: 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
|
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Cortico-synergy coherence
Tijdsspanne: 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 uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS)
Tijdsspanne: 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)
|
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National Institutes of Health Stroke Scale (NIHSS)
Tijdsspanne: 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)
|
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Fugl-Meyer assesment - Upper limbs
Tijdsspanne: 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
Tijdsspanne: 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)
|
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Tardieu scale
Tijdsspanne: 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
Tijdsspanne: 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)
|
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10 Meter Walking Test
Tijdsspanne: 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)
|
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10 Meter Walking Test
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital
Studie record data
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ONZ-2024-0089
- 11PEU24N (Ander subsidie-/financieringsnummer: FWO)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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