NCT06442579

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. 1.How can muscle synergies explain arm swing alterations in independent walkers after stroke?
  2. 2.How do stroke-induced changes in cortical activity relate to arm swing deviations in persons after stroke?
  3. 3.Are changes in primary motor control of the upper limb during walking related to normalization of brain activity in independent walkers after stroke?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for not_applicable healthy

Timeline
17mo left

Started Jul 2024

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jul 2024Sep 2027

First Submitted

Initial submission to the registry

May 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 9, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

2.5 years

First QC Date

May 29, 2024

Last Update Submit

November 14, 2025

Conditions

HealthyStroke

Keywords

EMGEEGGaitArm swingKinematics

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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)

  • 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

  • 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)

  • 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

  • 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 Outcomes (4)

  • Upper limb kinematics

    Single point of assessment at inclusion

  • Upper limb kinematics

    Single point of assessment 3 months after inclusion (only for stroke survivors)

  • Cortico-synergy coherence

    Single point of assessment at inclusion

  • Cortico-synergy coherence

    Single point of assessment 3 months after inclusion (only for stroke survivors)

Other Outcomes (10)

  • National Institutes of Health Stroke Scale (NIHSS)

    Single point of assessment at inclusion (only for stroke survivors)

  • National Institutes of Health Stroke Scale (NIHSS)

    Single point of assessment 3 months after inclusion (only for stroke survivors)

  • Fugl-Meyer assesment - Upper limbs

    Single point of assessment at inclusion (only for stroke survivors)

  • +7 more other outcomes

Study Arms (2)

Stroke

EXPERIMENTAL

Persons with a unilateral first ever stroke

Other: Walking on a treadmill

Control

ACTIVE COMPARATOR

Age and gender matched healthy controls

Other: Walking on a treadmill

Interventions

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.

ControlStroke

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First-ever and cerebral stroke
  • Able to walk at least 10 minutes (FAC ≥ 3)
  • Presence of upper limb paresis (NIHSS item 5a/b \> 0)

You may not qualify if:

  • Other neurological disorders
  • Healthy controls
  • Older than 18 years
  • Able to walk at least 10 minutes
  • Exlusion criteria:
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anke Van Bladel, PhD

    Ghent University and Ghent University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arne Defour, Msc.

CONTACT

09 332 12 43Arne.Defour@UGent.be

Anke Van Bladel, PhD

CONTACT

09 332 12 43Anke.VanBladel@UGent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 4, 2024

Study Start

July 9, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

September 30, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

BE(1)