Clinical trial NCT06442579: The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
Official title: The Influence of Cortical Lateralization on Selective Motor Control of the Arm Swing During Independent Walking After Stroke.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Healthy
Keywords: EMG
EEG
Gait
Arm swing
Kinematics
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: VU University of Amsterdam
name: Vrije Universiteit Brussel
First posted: 2024-06-04
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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?


Eligibility criteria: 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

Primary outcomes:
measure: Number of muscle synergies
timeFrame: Single point of assessment at inclusion
measure: Number of muscle synergies
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Weight of muscle synergies
timeFrame: Single point of assessment at inclusion
measure: Weight of muscle synergies
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Brain symmetry index (BSI)
timeFrame: Single point of assessment at inclusion
measure: Brain symmetry index (BSI)
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
Secondary outcomes:
measure: Upper limb kinematics
timeFrame: Single point of assessment at inclusion
measure: Upper limb kinematics
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Cortico-synergy coherence
timeFrame: Single point of assessment at inclusion
measure: Cortico-synergy coherence
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
Other outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Single point of assessment at inclusion (only for stroke survivors)
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Fugl-Meyer assesment - Upper limbs
timeFrame: Single point of assessment at inclusion (only for stroke survivors)
measure: Fugl-Meyer assesment - Upper limbs
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Tardieu scale
timeFrame: Single point of assessment at inclusion (only for stroke survivors)
measure: Tardieu scale
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: 10 Meter Walking Test
timeFrame: Single point of assessment at inclusion (only for stroke survivors)
measure: 10 Meter Walking Test
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
measure: Fugl-Meyer assesment - Lower limbs
timeFrame: Single point of assessment at inclusion (only for stroke survivors)
measure: Fugl-Meyer assesment - Lower limbs
timeFrame: Single point of assessment 3 months after inclusion (only for stroke survivors)
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: Oost-Vlaanderen
Study officials:
affiliation: Ghent University and Ghent University Hospital
name: Anke Van Bladel, PhD
role: PRINCIPAL_INVESTIGATOR
References: