The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.

Healthy Clinical Trial

Official title:

The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06442579
• Other study ID #: ONZ-2024-0089
• Secondary ID: 11PEU24N
• Status: Recruiting
• Start date: June 15, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: June 2024
• Source: University Hospital, Ghent
• Contact: Arne Defour, Msc.
• Phone: 09 332 12 43
• Email: Arne.Defour[@]UGent.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Stroke

Inclusion Criteria:

• First-ever, ischemic and cerebral stroke

• Maximum one-year post-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

Related Conditions & MeSH terms

• Healthy
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Walking on a treadmill
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent	Oost-Vlaanderen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent, Vrije Universiteit Brussel, VU University of Amsterdam

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	National Institutes of Health Stroke Scale (NIHSS)	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)
Other	National Institutes of Health Stroke Scale (NIHSS)	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)
Other	Fugl-Meyer assesment - Upper limbs	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)
Other	Fugl-Meyer assesment - Upper limbs	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)
Other	Tardieu scale	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)
Other	Tardieu scale	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)
Other	10 Meter Walking Test	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)
Other	10 Meter Walking Test	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)
Other	Fugl-Meyer assesment - Lower limbs	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)
Other	Fugl-Meyer assesment - Lower limbs	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)
Primary	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	Single point of assessment at inclusion
Primary	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	Single point of assessment 3 months after inclusion (only for stroke survivors)
Primary	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	Single point of assessment at inclusion
Primary	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	Single point of assessment 3 months after inclusion (only for stroke survivors)
Primary	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.	Single point of assessment at inclusion
Primary	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.	Single point of assessment 3 months after inclusion (only for stroke survivors)
Secondary	Upper limb kinematics	Movements of the upper limb during walking measured by 3D kinematics and expressed as angles (°)	Single point of assessment at inclusion
Secondary	Upper limb kinematics	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)
Secondary	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.	Single point of assessment at inclusion
Secondary	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.	Single point of assessment 3 months after inclusion (only for stroke survivors)