Stroke Gait RehabilitationNMCNCT07798388
Optimizing Gait Rehabilitation After Stroke
A study testing VR-feedback application in people with Stroke Gait Rehabilitation, run by University Hospital, Ghent at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- VR-feedback application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesBelgium
- Study dates
- 2 Sep 2026to 30 Jun 2028
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Not yet recruiting
UHasselt - Faculteit Revalidatiewetenschappen
Diepenbeek, 3590
Gitte Van Cleemput, 093321243, gitte.vancleemput@ugent.be
Pieter Meyns, Prof., +3211269395, pieter.meyns@uhasselt.be
- Not yet recruiting
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Gitte Van Cleemput, Prof., 093321243, gitte.vancleemput@ugent.be
Ann Hallemans, +32 3 265 29 12, ann.hallemans@uantwerpen.be
- Recruiting
University Hospital Ghent (UZ Gent), Belgium
Ghent, Oost-Vlaanderen, 9000
Gitte Van Cleemput, 093321243, gitte.vancleemput@ugent.be
Anke Van Bladel
About this study
Official title: Optimizing Gait Rehabilitation After Stroke: Neuromechanical Understanding and the Role of VR Feedback to Improve Arm Swing Functionality
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
- Being tested
- VR-feedback application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-feedback applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| neuromechanical understanding and the role of VR feedback to improve arm swing functionality | Experimental | Not described Receives: Other: VR-feedback application |
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: 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
Measured: Baseline, during intervention and immediately after the intervention.
Upper and lower limb kinematics
Movements of the upper limb during walking measured by 3D kinematics.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Single point of assessment immediately after the intervention
Secondary outcomes (5)
Fugl-Meyer assessment - Upper and lower limbs
The Fugl-Meyer Assessment (FMA) evaluates motor impairment of the upper (FMA-UL) and lower (FMA-LL) extremities. The upper-limb section includes 33 items (maximum score: 66), and the lower limb section includes 17 items (maximum score: 34). Items are scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Measured: Single point of assessment immediately after the intervention
Modified Tardieu Scale
The Modified Tardieu Scale (MTS) measures spasticity by assessing the muscle response to passive stretch at different velocities (V1 - V3). It evaluates both the quality of muscle reaction (0 = no resistance to 5 = immovable joint) and the angle of muscle reaction. Full passive ROM (R2) is assessed at slow velocity (V1). The angle at which a catch or clonus occurs (R1) is measured during stretch at V2 (limb falling under gravity) or V3 (quick stretch). The difference (R2 - R1) reflects the dynamic component of spasticity. The muscle groups that may influence the measured muscle activity of the upper and lower limbs will be tested. These include shoulder internal rotators, shoulder extensors, elbow flexors, elbow extensors, hip abductors, hip extensors, hip flexors, knee extensors, knee flexors, and plantar flexors.
Measured: Single point of assessment immediately after the intervention
Goniometry
Goniometry quantifies passive shoulder and elbow ROM. Measurements are obtained using a standard handheld goniometer, following conventional positioning and alignment procedures to ensure reliable documentation of joint mobility.
Measured: Single point of assessment immediately after the intervention
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test (10MWT) assesses walking capacity. Participants walk a 10-meter distance at a comfortable pace, and the time required to cover the central 10 meters (excluding acceleration and deceleration phases) is recorded. Walking speed (m/s) is calculated as an indicator of functional ambulation.
Measured: Single point of assessment immediately after the intervention
Kessler Foundation Neglect Assessment Process (KF-NAP)
The Kessler Foundation Neglect Assessment Process (KF-NAP) assesses the presence and severity of unilateral neglect during observations of the patient's behavior. It consists of 10 items, each scored from 0 to 3 (0 = no neglect, 1 = mild, with midline crossing only after attention to the right side, 2 = moderate, with clear and consistent left side omissions, and 3 = severe). Total scores range from 0 (indicating no neglect) to 30 (indicating severe neglect). Items 9 and 10, which involve eating tasks, will not be assessed because they cannot be performed in the laboratory setting. The final KF-NAP score will therefore be calculated by averaging the scores of the 8 assessed items and scaling the result to a 0-30 range using the following formula: (sum score / number of scored categories) x 10.
Measured: Single point of assessment immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start2 Sep 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Gait RehabilitationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Universiteit Antwerpen, University Hospital, Antwerp, Hasselt University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798388
- Sponsor's protocol ID
- ONZ-2026-0017
- Acronym
- NMC
- Status last verified
- Sep 2026
- First submitted
- 22 Jun 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Optimizing Gait Rehabilitation After Stroke: Neuromechanical Understanding and the Role of VR Feedback to Improve Arm Swing Functionality
- ClinicalTrials.gov ID
- NCT07798388
- Acronym / sponsor ID
- NMC / ONZ-2026-0017
- Conditions
- Stroke Gait Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Universiteit Antwerpen, University Hospital, Antwerp, Hasselt University
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 1 Sep 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neuromechanical understanding and the role of VR feedback to improve arm swing functionality | Experimental | Other: VR-feedback application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| VR-feedback applicationThe 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. | Other | neuromechanical understanding and the role of VR feedback to improve arm swing functionality |
Primary outcome
Number of muscle synergies
Time frame: Baseline, during intervention and immediately after the intervention.
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
Weight of muscle synergies
Time frame: Baseline, during intervention and immediately after the intervention.
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
Upper and lower limb kinematics
Time frame: Baseline, during intervention and immediately after the intervention.
Movements of the upper limb during walking measured by 3D kinematics.
Physical Activity Enjoyment Scale (PACES)
Time frame: Single point of assessment immediately after the intervention
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.
Simulation Task Load Index (SIM-TLX)
Time frame: Single point of assessment immediately after the intervention
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.
List of potential adverse effects
Time frame: Single point of assessment immediately after the intervention
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.
5 secondary outcomes
Fugl-Meyer assessment - Upper and lower limbs
Time frame: Single point of assessment immediately after the intervention
Modified Tardieu Scale
Time frame: Single point of assessment immediately after the intervention
Goniometry
Time frame: Single point of assessment immediately after the intervention
10-Meter Walk Test (10MWT)
Time frame: Single point of assessment immediately after the intervention
Kessler Foundation Neglect Assessment Process (KF-NAP)
Time frame: Single point of assessment immediately after the intervention
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.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-feedback application in people with Stroke Gait Rehabilitation, run by University Hospital, Ghent at 3 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 5 inclusion and 10 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 3 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 Gitte Van Cleemput (+3293321243, gitte.vancleemput@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: Baseline, during intervention and immediately after the intervention.). 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; AzTrials last refreshed its copy on 31 Oct 2026.