Optimizing Gait Rehabilitation After Stroke

NCT07798388 | Recruiting DMC

• 1 other identifier: ONZ-2026-0017
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

Brief Summary

Following a cerebrovascular accident (CVA, also known as a stroke), hemiparesis occurs on the side opposite to the brain injury. This can lead to problems with walking and balance, as well as with arm movements whilst walking. The arm swing serves several important functions whilst walking, such as improving your balance and energy efficiency, and a good arm swing helps to reduce the likelihood of falling if you lose your balance. That is why regaining the ability to walk independently with the best possible arm swing is a key goal during rehabilitation for people who have had a stroke. This ensures that the risk of falling is minimised and that people can resume their daily lives as effectively as possible. The aim of this study is to gain a better understanding of the abnormalities in arm swing whilst walking in people who have had a stroke, and how we can influence them. To identify these abnormalities, we use surface electromyography, a painless technique that allows us to measure muscle activity whilst walking. To do this, we attach sensors to the muscles whose activity we wish to record. During this study, we are measuring both people who have had a stroke and healthy adults, in order to detect the effects of a stroke on this muscle activity. The data from the healthy adults will be used to investigate whether we observe different muscle activity in people who have had a stroke.

Conditions

Stroke Gait Rehabilitation

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

  Baseline, during intervention and immediately after the intervention.

• 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

  Baseline, during intervention and immediately after the intervention.

• Upper and lower limb kinematics

  Movements of the upper limb during walking measured by 3D kinematics.

  Baseline, during intervention and immediately after the intervention.

• Physical Activity Enjoyment Scale (PACES)

  The PACES is a questionnaire on patient enjoyment of physical activity. It consists of 18 items rated on a 7-point Likert scale, with total scores ranging from 18 to 126.

  Single point of assessment immediately after the intervention

• Simulation Task Load Index (SIM-TLX)

  The SIM-TLX is a questionnaire to assess the workload in simulation and virtual reality. It consists of 10 items rated on a 21-point Likert scale, with total scores ranging from 21 to 210.

  Single point of assessment immediately after the intervention

• List of potential adverse effects

  A predefined list of potential adverse effects of the VR-feedback application is used to document any experienced adverse effects experienced by participants including an open section for additional unlisted effects.

  Single point of assessment immediately after the intervention

Secondary Outcomes (5)

• Fugl-Meyer assessment - Upper and lower limbs

  Single point of assessment immediately after the intervention

• Modified Tardieu Scale

  Single point of assessment immediately after the intervention

• Goniometry

  Single point of assessment immediately after the intervention

• 10-Meter Walk Test (10MWT)

  Single point of assessment immediately after the intervention

• Kessler Foundation Neglect Assessment Process (KF-NAP)

  Single point of assessment immediately after the intervention

Study Arms (1)

neuromechanical understanding and the role of VR feedback to improve arm swing functionality

EXPERIMENTAL

Other: VR-feedback application

Interventions

VR-feedback application OTHER

The VR-feedback application targets the arm swing symmetry during gait. The application provides visual real-time feedback on the amplitude and symmetry of shoulder flexion-extension movements, as well as on excessive elbow flexion.

neuromechanical understanding and the role of VR feedback to improve arm swing functionality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever ischemic or haemorrhagic stroke
• Able to walk independently (FAC ≥ 3)
• Able to walk at least ten minutes
• No full recovery of the paretic upper limb (FMA-UL \< 66)
• Able to follow simple instructions during the assessment

You may not qualify if:

• Lesions located in the cerebellum
• Pre-existing neurological disorders that affect motor function (e.g., Parkinson's disease, multiple sclerosis, dementia, etc.)
• Pre-existing orthopaedic disorders of the upper and/or lower limbs (e.g., shoulder prosthesis, knee prosthesis, etc.)
• Inability to provide written informed consent
• Inability to understand instructions (AbilityQ: verbal \< 3/4 and VAS \< 3/3)
• Pre-existing neurological disorders that affect motor function (e.g., Parkinson's disease, multiple sclerosis, dementia, etc.)
• Pre-existing orthopaedic disorders of the upper and/or lower limbs (e.g., shoulder prosthesis, knee prosthesis, etc.)
• Injuries of the upper and/or lower limbs that occurred six months or less prior to the time of testing
• Current pain or ROM limitations at the time of testing
• Inability to provide written informed consent

Sponsors & Collaborators

• Hasselt University: collaborator
• University Hospital, Ghent: lead
• University Ghent: collaborator
• Universiteit Antwerpen: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (3)

University Hospital Ghent (UZ Gent), Belgium

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

UHasselt - Faculteit Revalidatiewetenschappen

Diepenbeek, 3590, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

NOT YET RECRUITING

Central Study Contacts

Gitte Van Cleemput

CONTACT

+3293321243; gitte.vancleemput@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: September 1, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

BE (3)