StrokeNCT07178535
Feasibility of Real-Time Visual Feedback in Augmented Reality to Reduce Gait Asymmetry Post-Stroke
A study testing Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality in people with Stroke, run by McGill University at 1 site in Canada.
Trial summary
Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2027to 15 Sep 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants must be in the subacute phase, between 14 days and 6 months following a first supratentorial stroke
- able to walk with or without an assistive device for at least 2.5 minutes
- present spatial asymmetry (step length ratio, SLR > 1.08)
Who cannot join
- Abnormal or no-corrected visual acuity (EDTRS < 50/20)
- visual field deficits (Goldmann or computerized perimetry)
- cognitive impairment (Montreal Cognitive Assessment score < 22
- not being able to provide informed consent
- present other conditions besides stroke that limit walking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Jewish Rehabilitation Hospital - CISSS Laval
Laval, Quebec, H7V 1R2
Anouk Lamontagne, Associate Professor, (450) 688-9550 ext.84168, anouk.lamontagne@mcgill.ca
Anouk Lamontagne, Associate Professor
About this study
Official title: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality Environment to Reduce Spatial Gait Asymmetry in Adults Post-Stroke
Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Conventional rehabilitation has shown limited effectiveness in addressing this issue, highlighting the need for innovative approaches. Real-time feedback interventions, particularly through augmented reality (AR), may help improve gait asymmetry by providing a more natural and interactive learning environment.
This study aims to compare the effectiveness of two types of real-time visual feedback, an avatar-based system and visual bars, in improving gait symmetry and other locomotor parameters in individuals post-stroke. It will also assess the acceptability and usability of the intervention, participants' sense of presence, and the potential for cybersickness induced by these systems.
Read more
A repeated-measures design will be used to evaluate the immediate effectiveness of the two types of visual feedback on gait asymmetry and other locomotor parameters in adults in the subacute phase after stroke. Participants, aged 18 to 65 and presenting spatial asymmetry, will perform walking trials in an AR environment while being exposed to both feedback modalities in randomized order. Spatiotemporal and kinematic data will be collected using inertial sensors, while questionnaires will assess acceptability, usability, sense of presence, and cybersickness.
Participants will be evaluated in a 45-m long corridor (free of traffic) and will perform nine walking trials (three per condition) under three randomized conditions: (1) a lateral view avatar displayed on the paretic side, previously shown to provide optimal feedback on step length; (2) a visual bar feedback representing bilateral step lengths; and (3) a "control" condition with no additional feedback. Each walking trial, lasting 2.5 minutes, will consist of a pre-adaptation phase without feedback (30 s), followed by an adaptation phase with feedback (1 min), and a post-adaptation phase without feedback (1 min).
The investigators expect that avatar-based feedback will be more effective than visual bars in improving spatial symmetry. The investigators also anticipate that both feedback modalities will be well accepted and usable by participants without inducing cybersickness, but that the sense of presence will be higher with avatar-based feedback. This study will shed light on locomotor adjustment mechanisms and may lay the groundwork for future clinical trials. By offering a personalized, evidence-based approach, these results could help transform post-stroke rehabilitation through the integration of innovative tools to optimize functional recovery.
- Conditions
- Stroke
- Being tested
- Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality
- Keywords
- Post-stroke locomotor deficits, Spatial gait asymmetry, Real-time visual feedback, Augmented reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of Two Types of Real-Time Visual Feedback in an Augmented RealityDevice
Participants will walk in a corridor (45 m), equipped with "Xsens" inertial sensors recording their kinematics and an "HTC Vive Elite-XR" AR headset superimposing virtual feedback onto the real world. Three real-time feedback conditions (3 trials/condition) will be evaluated randomly: (1) an avatar reflecting the participant's movements; (2) visual bars indicating step lengths; (3) control condition without feedback. Participants take part in an evaluation/intervention session.
| Study group | Role | What they receive |
|---|---|---|
| Participant | Experimental | Not described Receives: Device: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length ratio
For the ratio calculation, the mean step length values from the left and right sides will be used, with the larger value placed in the numerator to ensure that all individual ratios are >1.0. A ratio of 1.0 will indicate perfect symmetry. We will compare the step length ratio (SLR)
Measured: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Secondary outcomes (11)
Walking speed
Comparison of walking speed (product of step length and cadence) in meter per second
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Step width
Comparison of step width in meter
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Gait cycle duration percentages
Gait cycle duration percentages (single support phase, corresponding to the contralateral swing phase, and double support phase) in percentage
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Trunk and pelvis maximum range of motion
For the trunk and pelvis, we will measure the maximum range of motion in the sagittal and frontal planes in Degree
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Hip and knee range of motion
For the hip and knee, we will measure in the sagittal plane the peak extension during stance, the peak flexion during swing, and the maximum range of motion. in Degree
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Ankle range of motion
For the ankle, we will measure in the sagittal plane the peak dorsiflexion at initial contact and during swing, as well as the peak plantarflexion at the end of double support uring the gait cycle. In degree
Measured: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Acceptability
Participant's comments and observations collected using the Theoretical Framework of Acceptability (TFA) Questionnaire, which considers different dimensions such as affective attitude, perceived effectiveness, ethicality and opportunity cost. It comprises 8 items rated from 1 to 5. Minimum value is 8 and maximum value is 40. A higher score is associated with better outcomes.
Measured: Investigators will compare these parameters before et after the session.
Usability
Participants' responses will be collected using the Single Ease Question (SEQ) questionnaire, which assesses task difficulty on a scale from 1 (very difficult) to 7 (very easy). The questionnaire consists of a single item, with higher scores indicating better usability.
Measured: Investigators will compare these parameters before and after the intervention.
Embodiment
The Virtual Embodiment Questionnaire (VEQ) is a quantitative measure of the degree to which a person experiences a sense of embodiment in a virtual body within a virtual reality environment. The score is obtained by summing responses to the questionnaire items, which assess three key components of embodiment: body ownership (5 items), agency (5 items), and changes in body schema (6 items). For each item, participants indicate their level of agreement on a 7-point scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree." A higher score reflects a greater sense of virtual embodiment.
Measured: Investigators will compare these parameters before et after the intervention.
Sens of Presence
The Holistic Presence Questionnaire (HPQ) is a quantitative measure of presence, assessing telepresence, internal and external plausibility, and perceived behavioral and cognitive affordances within a mediated environment in five items. For each item, participants indicate their level of agreement on a 7-point scale, where 1 corresponds to "strongly disagree" and 7 to "strongly agree." A higher score reflects a greater sense of presence in the virtual environment.
Measured: Investigators will compare these parameters before et after the session.
Cybersickness
The " Fast Motion Sickness Questionnaire " is a single-item verbal self-assessment scale ranging from 0 (no cybersickness) to 20 (severe cybersickness). A higher score indicates greater cybersickness
Measured: Investigators will compare these parameters before et after the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start15 Jan 2027 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anouk Lamontagne, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178535
- Sponsor's protocol ID
- MP-50-2025-2284
- Other IDs
- 2025-2026 - BF7 - 363369
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality Environment to Reduce Spatial Gait Asymmetry in Adults Post-Stroke
- ClinicalTrials.gov ID
- NCT07178535
- Acronym / sponsor ID
- MP-50-2025-2284
- Conditions
- Stroke
- Keywords
- Post-stroke locomotor deficits, Spatial gait asymmetry, Real-time visual feedback, Augmented reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 17 Sep 2025 (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.
Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Conventional rehabilitation has shown limited effectiveness in addressing this issue, highlighting the need for innovative approaches. Real-time feedback interventions, particularly through augmented reality (AR), may help improve gait asymmetry by providing a more natural and interactive learning environment.
This study aims to compare the effectiveness of two types of real-time visual feedback, an avatar-based system and visual bars, in improving gait symmetry and other locomotor parameters in individuals post-stroke. It will also assess the acceptability and usability of the intervention, participants' sense of presence, and the potential for cybersickness induced by these systems.
A repeated-measures design will be used to evaluate the immediate effectiveness of the two types of visual feedback on gait asymmetry and other locomotor parameters in adults in the subacute phase after stroke. Participants, aged 18 to 65 and presenting spatial asymmetry, will perform walking trials in an AR environment while being exposed to both feedback modalities in randomized order. Spatiotemporal and kinematic data will be collected using inertial sensors, while questionnaires will assess acceptability, usability, sense of presence, and cybersickness.
Participants will be evaluated in a 45-m long corridor (free of traffic) and will perform nine walking trials (three per condition) under three randomized conditions: (1) a lateral view avatar displayed on the paretic side, previously shown to provide optimal feedback on step length; (2) a visual bar feedback representing bilateral step lengths; and (3) a "control" condition with no additional feedback. Each walking trial, lasting 2.5 minutes, will consist of a pre-adaptation phase without feedback (30 s), followed by an adaptation phase with feedback (1 min), and a post-adaptation phase without feedback (1 min).
The investigators expect that avatar-based feedback will be more effective than visual bars in improving spatial symmetry. The investigators also anticipate that both feedback modalities will be well accepted and usable by participants without inducing cybersickness, but that the sense of presence will be higher with avatar-based feedback. This study will shed light on locomotor adjustment mechanisms and may lay the groundwork for future clinical trials. By offering a personalized, evidence-based approach, these results could help transform post-stroke rehabilitation through the integration of innovative tools to optimize functional recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant | Experimental | Device: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All participants must be in the subacute phase, between 14 days and 6 months following a first supratentorial stroke
- able to walk with or without an assistive device for at least 2.5 minutes
- present spatial asymmetry (step length ratio, SLR > 1.08)
Key exclusion criteria (5 listed)
- Abnormal or no-corrected visual acuity (EDTRS < 50/20)
- visual field deficits (Goldmann or computerized perimetry)
- cognitive impairment (Montreal Cognitive Assessment score < 22
- not being able to provide informed consent
- present other conditions besides stroke that limit walking.
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 |
|---|---|---|
| Feasibility of Two Types of Real-Time Visual Feedback in an Augmented RealityParticipants will walk in a corridor (45 m), equipped with "Xsens" inertial sensors recording their kinematics and an "HTC Vive Elite-XR" AR headset superimposing virtual feedback onto the real world. Three real-time feedback conditions (3 trials/condition) will be evaluated randomly: (1) an avatar reflecting the participant's movements; (2) visual bars indicating step lengths; (3) control condition without feedback. Participants take part in an evaluation/intervention session. | Device | Participant |
Primary outcome
Step length ratio
Time frame: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
For the ratio calculation, the mean step length values from the left and right sides will be used, with the larger value placed in the numerator to ensure that all individual ratios are >1.0. A ratio of 1.0 will indicate perfect symmetry. We will compare the step length ratio (SLR)
11 secondary outcomes
Walking speed
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Step width
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Gait cycle duration percentages
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Trunk and pelvis maximum range of motion
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Hip and knee range of motion
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Ankle range of motion
Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).
Acceptability
Time frame: Investigators will compare these parameters before et after the session.
Usability
Time frame: Investigators will compare these parameters before and after the intervention.
Embodiment
Time frame: Investigators will compare these parameters before et after the intervention.
Sens of Presence
Time frame: Investigators will compare these parameters before et after the session.
Cybersickness
Time frame: Investigators will compare these parameters before et after the session
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 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality in people with Stroke, run by McGill University at 1 site in Canada.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 Anouk Lamontagne, Associate Professor ((450) 688-9550 ext.84168, anouk.lamontagne@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length ratio (time frame: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).). 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 7 Oct 2026.