Subacute StrokeMAVREECNCT06972355
Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke
A study testing Hiding the eyes in people with Subacute Stroke, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
Objective: The aim of this study is to compare the efficiency of vision-obscured versus vision-retained treadmill gait training in subacute post-stroke patients. Methodology: Thirty-six patients with stroke (ischemic or hemorrhagic) less than six months old will be included and randomized into two parallel groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacute Stroke
- What is being tested?
- Hiding the eyes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2025to 19 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- With a confirmed diagnosis of ischemic or hemorrhagic stroke in sub-acute phase (stroke less than 6 months old),
- With NIHSS scores between 1 and 15 and MoCA scores between 18 and 30
- With a physiotherapy prescription for post Stroke rehabilitation
- Able to walk for 20 min on a treadmill with weight reduction with pauses, able to maintain bipodal balance, able to maintain bipodal balance with eyes open and closed for 30 seconds,
- Having expressed free, informed and written consent
- Affiliated with a social security scheme.
Who cannot join
- Patients weighing over 200 kg (maximum weight permitted for use of the Lite Gait ®),
- Patients with impaired vision:
- Best corrected visual acuity below 5/10 on patient examination
- Homonymous lateral hemianopia, quadranopia.
- Inability to physically participate in intensive rehabilitation due to severe, unstabilized and comorbidities (heart, lung, kidney disease or diabetes), severe psychiatric disorders cancer active or under treatment.
- Patients participating in other interventional research,
- Pregnant or breast-feeding women,
- Patients under guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville Hopital Legouest
Metz, 57085
Arpiné EL NAR, PhD, 0033387557766, projet-recherche-clinique@chr-metz-thionville.fr
Pauline AMSTUTZ
About this study
Official title: Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke, Randomized Controlled Trial
Objective: The aim of this study is to compare the efficiency of vision-obscured versus vision-retained treadmill gait training in subacute post-stroke patients.
Methodology: Thirty-six patients with stroke (ischemic or hemorrhagic) less than six months old will be included and randomized into two parallel groups. The experimental group will undergo treadmill gait training using an opaque mask, combined with body weight reduction (Lite Gait® harness). The control group will follow the same walking protocol, but with their eyes open. Each session will last 20 minutes, integrated into one hour of rehabilitation, at a rate of three sessions per week for six weeks. Assessment will include single- and double-task walking speed, balance parameters and proprioception.
Read more
Expected results: The hypothesis is that visual deprivation will stimulate the proprioceptive and vestibular systems to a greater extent, resulting in benefits for postural balance, walking and proprioception. The main hypothesis will be the improvement in the difference between single-task and double-task walking speed. Analyses will be conducted on an intention-to-treat basis, using statistical tests adapted to the nature of the variables.
Conclusion: This study could highlight the value of temporary visual suppression as a therapeutic lever in stroke rehabilitation.
Read the detailed description
Background: Gait rehabilitation for stroke patients is a major issue in post-stroke functional recovery. The impact of vision on walking and balance is well documented, however, visuo-dependence (the dependence on vision for spatial orientation and balance control) is often neglected in current rehabilitation programs. Programs dealing with visuo-dependence mainly target pediatric, geriatric or chronic stroke populations, but their use and study remain limited in the literature. Moreover, these programs have never been studied in the context of the sub-acute phase of stroke. The issue of visuo-dependence is particularly relevant in this phase, as it occurs at a time when brain plasticity is still possible and appropriate rehabilitation strategies are needed.
Aims
The primary aim of this study is to evaluate the effects of treadmill walking training with vision suppression (eyes closed) on double-task walking speed.
Secondary objectives are to study balance parameters, including lateral variance of the center of pressure (with eyes open and closed), area covered by the center of pressure (eyes open and closed), Romberg quotient and MCTSIB score. Gait parameters such as 10-meter test speed (10MWT), mean step duration, symmetry and cycle length variability will also be studied. Finally, proprioception parameters will be assessed using the JPS test.
The primary hypothesis is that the absence of vision significantly improves the difference in walking speed between single-task and double-task walking. The secondary hypothesis is that this absence of vision would also improve proprioception parameters, gait quality and balance, by forcing increased activation of the other senses (proprioception, vestibular system), thus leading to somatosensory compensation.
Methodology
This randomized, controlled study will involve sub-acute stroke patients (< 6 months), aged over 18, with deficits in walking, balance and proprioception. Participants will be randomly divided into two groups: an experimental group receiving gait training with eyes closed, and a control group practicing training with eyes open. Each participant will follow a rehabilitation program of 20 minutes of treadmill walking, three times a week, as part of physical therapy sessions lasting one hour a day, 5 times a week. Inclusion criteria included the ability to walk for 20 minutes on a treadmill with suspension and to walk 10 metres in the corridor, with or without technical aids. Exclusion criteria included severe associated pathologies and major cognitive impairment.
Conclusion and clinical implications : This study is innovative in that it explores the effects of vision suppression on gait and balance rehabilitation, specifically in sub-acute stroke patients, a population often neglected in existing research. The results could offer new perspectives for post-stroke rehabilitation, focusing on sensory compensation via proprioception and other senses. This approach could ultimately improve patients' quality of life and autonomy, by reducing their dependence on vision and optimizing their motor rehabilitation.
- Conditions
- Subacute Stroke
- Being tested
- Hiding the eyes
- Keywords
- Stroke, Gait, Treadmill, Double task, Proprioception, Postural balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hiding the eyesProcedure or surgery
Patients will participate in walking rehabilitation sessions on a treadmill supported by a Lite Gait® harness. All treadmill sessions are consistent with regular rehabilitation sessions. A typical treadmill walking session will take place 3 times a week for 6 weeks, lasting 20 minutes. During the first minute, the speed of the treadmill is gradually increased until a comfortable speed is reached. From then on, the mask will be placed over the patient's eyes for 18 minutes at a constant, i.e. comfortable, speed. The last minute will be devoted to gradually decreasing the treadmill speed until it stops, and will also be performed without the mask.
| Study group | Role | What they receive |
|---|---|---|
| Hidden Eyes | Experimental | Treadmill walking training with body weight reduced and eyes hidden Receives: Procedure: Hiding the eyes |
| Open Eyes | No intervention | Treadmill walking training with reduced body weight and open eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task walking speed assessment
Speed (m/s)
The dual-task walking speed assessment measures how well a person walks while simultaneously performing a cognitive or motor task. It helps identify changes in gait speed and stability when attention is divided, revealing potential fall risk or cognitive-motor interference.
Measured: 6 weeks after subacute stroke
Secondary outcomes (9)
Gait Speed assessment
Gait speed (m/s)
Measured: 3 to 6 monts after subacute stroke
Average step duration evaluation
Average step duration (s)
Measured: 3 to 6 monts after subacute stroke
Gait symmetry evaluation
Gait symmetry (%)
Measured: 3 to 6 monts after subacute stroke
Cycle duration variability evaluation
Cycle duration variability (%)
Measured: 3 to 6 monts after subacute stroke
Single-task and double-task gait speed evaluation
Single-task and double-task gait speed difference (%)
Measured: 3 to 6 monts after subacute stroke
Center of pressure position evaluation
Lateral variance of center of pressure position (cm²): under two conditions, eyes open and closed.
Measured: up to 6 weeks after subacute stroke
Proprioception parameters evaluation using Romberg's quotient
Romberg's quotient (cm²) The Romberg's quotient is used to evaluate proprioceptive contribution to balance by comparing postural sway with eyes closed versus eyes open.
It is calculated as:
Romberg's quotient = Sway with eyes closed / Sway with eyes open A higher quotient suggests greater reliance on visual input for balance and may indicate proprioceptive deficits. This assessment helps determine how well an individual uses proprioception when visual cues are removed.
Measured: up to 6 weeks after subacute stroke
Balance evaluation using CTSIB-M test
Time (s) maintained in CTSIB-M test (s)
The CTSIB-M (Modified Clinical Test of Sensory Interaction in Balance) assesses a person's ability to maintain balance under four conditions that challenge visual, vestibular, and somatosensory systems. It involves standing on firm and foam surfaces with eyes open or closed, and each condition is timed for up to 30 seconds.
Measured: up to 6 weeks after subacute stroke
Proprioception using Join Position Sense of the knee test
Join Position Sense (°) of the knee. The test involves passively or actively moving the knee to a target angle (e.g., 30° or 60° flexion), then asking the person to replicate that position with eyes closed. The error (in degrees) between the target and reproduced angle reflects proprioceptive precision.
Measured: up to 6 weeks after subacute stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start4 Jun 2025
- Primary completion4 Jun 2027 (estimated)
- Study completion19 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pauline AMSTUTZ, Principal investigator, CHR Metz Thionville Hopital Legouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972355
- Sponsor's protocol ID
- 2025-01-CHRMT
- Acronym
- MAVREEC
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treadmill Walking With Hidden Vision for Rehabilitation in the Subacute Phase of Stroke, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06972355
- Acronym / sponsor ID
- MAVREEC / 2025-01-CHRMT
- Conditions
- Subacute Stroke
- Keywords
- Stroke, Gait, Treadmill, Double task, Proprioception, Postural balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 4 Jun 2027 (estimated)
- Study completion
- 19 Jul 2027 (estimated)
- First posted
- 15 May 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.
Objective: The aim of this study is to compare the efficiency of vision-obscured versus vision-retained treadmill gait training in subacute post-stroke patients.
Methodology: Thirty-six patients with stroke (ischemic or hemorrhagic) less than six months old will be included and randomized into two parallel groups. The experimental group will undergo treadmill gait training using an opaque mask, combined with body weight reduction (Lite Gait® harness). The control group will follow the same walking protocol, but with their eyes open. Each session will last 20 minutes, integrated into one hour of rehabilitation, at a rate of three sessions per week for six weeks. Assessment will include single- and double-task walking speed, balance parameters and proprioception.
Expected results: The hypothesis is that visual deprivation will stimulate the proprioceptive and vestibular systems to a greater extent, resulting in benefits for postural balance, walking and proprioception. The main hypothesis will be the improvement in the difference between single-task and double-task walking speed. Analyses will be conducted on an intention-to-treat basis, using statistical tests adapted to the nature of the variables.
Conclusion: This study could highlight the value of temporary visual suppression as a therapeutic lever in stroke rehabilitation.
Detailed description
Background: Gait rehabilitation for stroke patients is a major issue in post-stroke functional recovery. The impact of vision on walking and balance is well documented, however, visuo-dependence (the dependence on vision for spatial orientation and balance control) is often neglected in current rehabilitation programs. Programs dealing with visuo-dependence mainly target pediatric, geriatric or chronic stroke populations, but their use and study remain limited in the literature. Moreover, these programs have never been studied in the context of the sub-acute phase of stroke. The issue of visuo-dependence is particularly relevant in this phase, as it occurs at a time when brain plasticity is still possible and appropriate rehabilitation strategies are needed.
Aims
The primary aim of this study is to evaluate the effects of treadmill walking training with vision suppression (eyes closed) on double-task walking speed.
Secondary objectives are to study balance parameters, including lateral variance of the center of pressure (with eyes open and closed), area covered by the center of pressure (eyes open and closed), Romberg quotient and MCTSIB score. Gait parameters such as 10-meter test speed (10MWT), mean step duration, symmetry and cycle length variability will also be studied. Finally, proprioception parameters will be assessed using the JPS test.
The primary hypothesis is that the absence of vision significantly improves the difference in walking speed between single-task and double-task walking. The secondary hypothesis is that this absence of vision would also improve proprioception parameters, gait quality and balance, by forcing increased activation of the other senses (proprioception, vestibular system), thus leading to somatosensory compensation.
Methodology
This randomized, controlled study will involve sub-acute stroke patients (< 6 months), aged over 18, with deficits in walking, balance and proprioception. Participants will be randomly divided into two groups: an experimental group receiving gait training with eyes closed, and a control group practicing training with eyes open. Each participant will follow a rehabilitation program of 20 minutes of treadmill walking, three times a week, as part of physical therapy sessions lasting one hour a day, 5 times a week. Inclusion criteria included the ability to walk for 20 minutes on a treadmill with suspension and to walk 10 metres in the corridor, with or without technical aids. Exclusion criteria included severe associated pathologies and major cognitive impairment.
Conclusion and clinical implications : This study is innovative in that it explores the effects of vision suppression on gait and balance rehabilitation, specifically in sub-acute stroke patients, a population often neglected in existing research. The results could offer new perspectives for post-stroke rehabilitation, focusing on sensory compensation via proprioception and other senses. This approach could ultimately improve patients' quality of life and autonomy, by reducing their dependence on vision and optimizing their motor rehabilitation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hidden Eyes | Experimental | Procedure: Hiding the eyesTreadmill walking training with body weight reduced and eyes hidden |
| Open Eyes | No intervention | –Treadmill walking training with reduced body weight and open eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older,
- With a confirmed diagnosis of ischemic or hemorrhagic stroke in sub-acute phase (stroke less than 6 months old),
- With NIHSS scores between 1 and 15 and MoCA scores between 18 and 30
- With a physiotherapy prescription for post Stroke rehabilitation
- Able to walk for 20 min on a treadmill with weight reduction with pauses, able to maintain bipodal balance, able to maintain bipodal balance with eyes open and closed for 30 seconds,
Key exclusion criteria (8 listed)
- Patients weighing over 200 kg (maximum weight permitted for use of the Lite Gait ®),
- Patients with impaired vision:
- Inability to physically participate in intensive rehabilitation due to severe, unstabilized and comorbidities (heart, lung, kidney disease or diabetes), severe psychiatric disorders cancer active or under treatment.
- Patients participating in other interventional research,
- Pregnant or breast-feeding women,
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 |
|---|---|---|
| Hiding the eyesPatients will participate in walking rehabilitation sessions on a treadmill supported by a Lite Gait® harness. All treadmill sessions are consistent with regular rehabilitation sessions. A typical treadmill walking session will take place 3 times a week for 6 weeks, lasting 20 minutes. During the first minute, the speed of the treadmill is gradually increased until a comfortable speed is reached. From then on, the mask will be placed over the patient's eyes for 18 minutes at a constant, i.e. comfortable, speed. The last minute will be devoted to gradually decreasing the treadmill speed until it stops, and will also be performed without the mask. | Procedure or surgery | Hidden Eyes |
Primary outcome
Dual-task walking speed assessment
Time frame: 6 weeks after subacute stroke
Speed (m/s) The dual-task walking speed assessment measures how well a person walks while simultaneously performing a cognitive or motor task. It helps identify changes in gait speed and stability when attention is divided, revealing potential fall risk or cognitive-motor interference.
9 secondary outcomes
Gait Speed assessment
Time frame: 3 to 6 monts after subacute stroke
Average step duration evaluation
Time frame: 3 to 6 monts after subacute stroke
Gait symmetry evaluation
Time frame: 3 to 6 monts after subacute stroke
Cycle duration variability evaluation
Time frame: 3 to 6 monts after subacute stroke
Single-task and double-task gait speed evaluation
Time frame: 3 to 6 monts after subacute stroke
Center of pressure position evaluation
Time frame: up to 6 weeks after subacute stroke
Proprioception parameters evaluation using Romberg's quotient
Time frame: up to 6 weeks after subacute stroke
Balance evaluation using CTSIB-M test
Time frame: up to 6 weeks after subacute stroke
Proprioception using Join Position Sense of the knee test
Time frame: up to 6 weeks after subacute stroke
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 1 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Subacute Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Functional Improvement in Subacute/Chronic Stroke Through Non-invasive Virtual-reality-Based Telerehabilitation
Stroke
Active, not recruiting
Comparative Effects of Sensorimotor Training and tACS on Upper Limb Function and Cervical Proprioception in Subacute Stroke
Sub-acute Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Pauline AMSTUTZ principal investigator
CHR Metz Thionville Hopital Legouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hiding the eyes in people with Subacute Stroke, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
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 7 inclusion and 8 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 1 Oct 2025. 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 France. 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 Arpiné EL NAR, PhD (0033387557766, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task walking speed assessment (time frame: 6 weeks after subacute stroke). 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 1 Oct 2025.