- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442579
The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
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?
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anke Van Bladel, PhD
- Phone Number: 09 332 12 43
- Email: Anke.VanBladel@UGent.be
Study Contact Backup
- Name: Arne Defour, Msc.
- Phone Number: 09 332 12 43
- Email: Arne.Defour@UGent.be
Study Locations
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgium
- Recruiting
- Ghent University Hospital
-
Contact:
- Anke Van Bladel, PhD
- Phone Number: 093321243
- Email: Anke.VanBladel@UGent.be
-
Principal Investigator:
- Arne Defour, Msc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Participants will be recruited directly from the University Hospital of Ghent through the rehabilitation centre (Prof Dr Kristine Oostra - Prof Dr Katie Bouche) and through the deparment for acute neurology (Prof Dr Veerle De Herdt). Flyers will also be distributed on social media and through rehabilitation physicians of the different hospitals in the Ghent area.
Patients will be informed of the study by their treating physician. The latter asks if the researchers may contact them to explain the study. The researcher will explain the study and provide the ICF to the potential candidate. Only upon agreement will an appointment for the study be scheduled.
Patients who are not directly addressed by the doctor but only see a flyer in the waiting room can contact the researcher via the contact details on the flyer.
Healthy controls will be recruited via an adapted flyer on social media (Facebook, X, LinkedIn).
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of muscle synergies
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper limb kinematics
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anke Van Bladel, PhD, Ghent University and Ghent University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2024-0089
- 11PEU24N (Other Grant/Funding Number: FWO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
University Hospital HeidelbergCompletedAcute Ischemic Stroke | Acute Ischemic Stroke AIS | Acute Ischemic Stroke PatientsGermany
Clinical Trials on Walking on a treadmill
-
Nantes University HospitalCompleted
-
Hopital FochCompletedWalking, DifficultyFrance
-
Meuhedet. Healthcare OrganizationCompleted
-
University of Arkansas, FayettevilleRecruitingDiabetes Mellitus, Type 2United States
-
Joslin Diabetes CenterCompletedHypoglycemia | Physical Activity | Roux-en-Y Gastric Bypass | Post-bariatric HypoglycemiaUnited States
-
Atlas UniversityCompletedFatigue | Autonomous Nervous SystemTurkey
-
University Hospital, GhentUniversity GhentRecruiting
-
Hacettepe UniversityUnknownAmputation | Gait | Dual TaskTurkey
-
Laval UniversityTerminatedParkinson's DiseaseCanada
-
Eunice Kennedy Shriver National Institute of Child...National Cancer Institute (NCI); National Institute of Diabetes and Digestive...CompletedHealthy VolunteerUnited States