HealthyNCT06442579
The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
A study testing Walking on a treadmill in people with Healthy and Stroke, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Walking on a treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesBelgium
- Study dates
- 9 Jul 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-ever and cerebral stroke
- Able to walk at least 10 minutes (FAC ≥ 3)
- Presence of upper limb paresis (NIHSS item 5a/b > 0)
- Older than 18 years
- Able to walk at least 10 minutes
- Exlusion criteria:
- Pregnancy
Who cannot join
- Other neurological disorders
- Healthy controls
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
UHasselt - Faculteit Revalidatiewetenschappen
Diepenbeek, 3590
Arne Defour, 093321243, arne.defour@ugent.be
Sophie De Mits, 093321243, Sophie.DeMits@UGent.be
- Recruiting
Ghent University Hospital
Ghent, Oost-Vlaanderen
Anke Van Bladel, PhD, 093321243, Sophie.DeMits@UGent.be
Arne Defour, Msc.
About this study
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.
Read more
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?
- Being tested
- Walking on a treadmill
- Keywords
- EMG, EEG, Gait, Arm swing, Kinematics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking on a treadmillOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | Persons with a unilateral first ever stroke Receives: Other: Walking on a treadmill |
| Control | Active comparator | Age and gender matched healthy controls Receives: Other: Walking on a treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of muscle synergies
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
Measured: Single point of assessment at inclusion
Number of muscle synergies
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
Measured: Single point of assessment 3 months after inclusion (only for stroke survivors)
Weight of muscle synergies
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
Measured: Single point of assessment at inclusion
Weight of muscle synergies
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
Measured: Single point of assessment 3 months after inclusion (only for stroke survivors)
Brain symmetry index (BSI)
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.
Measured: Single point of assessment at inclusion
Brain symmetry index (BSI)
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.
Measured: Single point of assessment 3 months after inclusion (only for stroke survivors)
Secondary outcomes (4)
Upper limb kinematics
Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)
Measured: Single point of assessment at inclusion
Upper limb kinematics
Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)
Measured: Single point of assessment 3 months after inclusion (only for stroke survivors)
Cortico-synergy coherence
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.
Measured: Single point of assessment at inclusion
Cortico-synergy coherence
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.
Measured: Single point of assessment 3 months after inclusion (only for stroke survivors)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start9 Jul 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, VU University of Amsterdam, Vrije Universiteit Brussel
- Responsible party
- Sponsor
- Investigators
- Anke Van Bladel, PhD, Principal investigator, Ghent University and Ghent University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442579
- Sponsor's protocol ID
- ONZ-2024-0089
- Other IDs
- 11PEU24N
- Status last verified
- Sep 2026
- First submitted
- 29 May 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
- ClinicalTrials.gov ID
- NCT06442579
- Acronym / sponsor ID
- ONZ-2024-0089
- Keywords
- EMG, EEG, Gait, Arm swing, Kinematics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, VU University of Amsterdam, Vrije Universiteit Brussel
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Other: Walking on a treadmillPersons with a unilateral first ever stroke |
| Control | Active comparator | Other: Walking on a treadmillAge and gender matched healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First-ever and cerebral stroke
- Able to walk at least 10 minutes (FAC ≥ 3)
- Presence of upper limb paresis (NIHSS item 5a/b > 0)
- Older than 18 years
- Able to walk at least 10 minutes
Key exclusion criteria (2 listed)
- Other neurological disorders
- Healthy controls
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking on a treadmillParticipants 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. | Other | Control, Stroke |
Primary outcome
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: * 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
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: * 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
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: * 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
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: * 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
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.
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.
4 secondary outcomes
Upper limb kinematics
Time frame: Single point of assessment at inclusion
Upper limb kinematics
Time frame: Single point of assessment 3 months after inclusion (only for stroke survivors)
Cortico-synergy coherence
Time frame: Single point of assessment at inclusion
Cortico-synergy coherence
Time frame: Single point of assessment 3 months after inclusion (only for stroke survivors)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anke Van Bladel, PhD principal investigator
Ghent University and Ghent University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking on a treadmill in people with Healthy and Stroke, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arne Defour, Msc. (09 332 12 43, Arne.Defour@UGent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of muscle synergies (time frame: Single point of assessment at inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.