Hemiparetic StrokeSI-VI-MINCT07629674
Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke
A study testing Active Videotherapy in people with Hemiparetic Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented. This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparetic Stroke
- What is being tested?
- Active Videotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - First or recurrent hemispheric ischemic or hemorrhagic stroke in the subacute or chronic phase (from 1 month to 1 year post-stroke).
- Currently receiving rehabilitation care in a Physical Medicine and Rehabilitation (PM\&R) department
- Able to walk 3 meters back and forth, with or without an assistive device.
- Provided informed consent, signed jointly with the investigator.
Who cannot join
- - Severe hemispatial neglect.
- Severe spasticity impairing proper positioning (Modified Ashworth Scale > 3).
- Severe general disabling medical conditions.
- Associated cerebellar syndrome.
- Major comprehension disorders, psychiatric illness, or cognitive impairments that could interfere with study participation.
- Participants under full legal guardianship (tutorship).
- Pregnant or breastfeeding women.
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
Service de Médecine Physique et réadaptation
Saint-Etienne, 42100
Diana RIMAUD, PhD, 04 77 12 04 67 ext. 33, Diana.Rimaud@chu-st-etienne.fr
Pascal GIRAUX, MD, PhD
About this study
Official title: Use of Intensive Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke (SIVIMI). A Single-Center Pilot Study Using a Single-Case Experimental Design (SCED)
This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented.
This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with subacute or chronic post-stroke hemiparesis. Twelve participants will be included and allocated to different baseline durations according to a multiple-baseline SCED design.
The primary outcome is functional mobility, assessed using the Timed Up and Go (TUG) test, measured repeatedly throughout baseline, intervention, and follow-up phases.
Read the detailed description
Stroke frequently results in persistent lower limb motor impairment affecting gait and functional mobility (1-2). While video-based therapies have shown proof of concept for upper limb rehabilitation after stroke, their effectiveness for lower limb motor recovery remains insufficiently documented (3-5).
This study is a single-center pilot trial using a Single-Case Experimental Design (SCED) with multiple baseline durations, chosen to account for the high interindividual variability observed in subacute and chronic post-stroke patients undergoing rehabilitation (6). This design allows each participant to serve as their own control through repeated measurements over time (6).
Participants are included between 1 month and 1 year post-stroke while receiving inpatient or outpatient rehabilitation in a Physical Medicine and Rehabilitation department. All participants initially undergo a control phase combining standardized rehabilitation with sham video therapy (placebo condition). The duration of this baseline phase is randomized (1, 2, or 3 weeks) across participants.
The experimental phase consists of 5 weeks of intensive video therapy added to usual care, with five sessions per week. A post-intervention sham phase is followed by a follow-up period lasting up to 21 weeks post-intervention, with repeated assessments conducted at weeks 13, 17, and 21 to evaluate maintenance of treatment effects.
The primary objective is to evaluate changes in functional mobility, assessed using repeated measurements of the Timed Up and Go test. Secondary objectives include evaluation of gait endurance, motor impairment, muscle tone, balance, and quality of life
.
- Conditions
- Hemiparetic Stroke
- Being tested
- Active Videotherapy, Sham videotherapy
- Keywords
- Videotherapy, Lower limb rehabilitation, Hemiplegic/Hemiparetic, Single case experimental design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active VideotherapyDevice
During active videotherapy sessions, the image inversion program is activated, superimposing movements of the non-paretic limb onto the paretic limb, which is hidden behind the screen. Participants are instructed to imagine and attempt to reproduce the observed movements using their paretic limb. Each participant completes 25 sessions over 5 weeks (5 sessions per week).
Sham videotherapyDevice
During sham videotherapy sessions, participants are seated facing the IVS4 screen without activation of the image inversion program. Participants perform lower limb movements while directly viewing their paretic limb in real time on the screen, corresponding to an action observation condition without visual illusion.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | 1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy. Receives: Device: Active Videotherapy; Device: Sham videotherapy |
| Sequence 2 | Experimental | 2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy. Receives: Device: Active Videotherapy; Device: Sham videotherapy |
| Sequence 3 | Experimental | 3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) , Receives: Device: Active Videotherapy; Device: Sham videotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Timed Up and Go Test (TUG)
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
Measured: 5-week
Secondary outcomes (7)
2. 2-Minute Walk Test (2MWT)
Walking endurance assessed by the distance walked in 2 minutes (in meters).
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
3. Fugl-Meyer Assessment - Lower Limb Section
Motor function of the hemiplegic lower limb, assessed with the Fugl-Meyer scale (score from 0 to 34)
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
4. Muscle Strength - Foot Dorsiflexors and extensors
Muscle strength of the foot dorsiflexors and extensors, measured in Newtons using a handheld dynamometer
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
5. Muscle Tone - Modified Ashworth Scale (MAS)
Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Ashworth Scale (score 0-5).
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
6. Muscle Tone - Modified Tardieu Scale
Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Tardieu Scale (score 0-5).
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
7. Postural Balance - PASS (Postural Assessment Scale for Stroke Patients)
Balance ability assessed using the PASS scale (score 0-36).
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
8. Quality of Life - Stroke Specific Quality of Life Scale (SS-QOL)
Quality of life assessed with the SS-QOL scale (score range: 49-245).
Measured: Weeks 1, 2, 3, 8, 13, 17, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start9 Jul 2026
- Primary completion31 Dec 2027 (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 Hemiparetic StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Model Description
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnauld GARCIN, Centre Hospitalier Universitaire de Saint Etienne
- Investigators
- Etienne OJARDIAS, Dr, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629674
- Sponsor's protocol ID
- 25CH169
- Other IDs
- 2025-A02102-47
- Acronym
- SI-VI-MI
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study has only 1 center
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Intensive Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke (SIVIMI). A Single-Center Pilot Study Using a Single-Case Experimental Design (SCED)
- ClinicalTrials.gov ID
- NCT07629674
- Acronym / sponsor ID
- SI-VI-MI / 25CH169
- Conditions
- Hemiparetic Stroke
- Keywords
- Videotherapy, Lower limb rehabilitation, Hemiplegic/Hemiparetic, Single case experimental design
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Jun 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.
This pilot study evaluates video therapy for lower limb motor recovery after stroke, an approach remains insufficiently documented.
This single-center pilot study uses a Single-Case Experimental Design (SCED) to evaluate the effects of intensive video therapy combined with conventional rehabilitation in patients with subacute or chronic post-stroke hemiparesis. Twelve participants will be included and allocated to different baseline durations according to a multiple-baseline SCED design.
The primary outcome is functional mobility, assessed using the Timed Up and Go (TUG) test, measured repeatedly throughout baseline, intervention, and follow-up phases.
Detailed description
Stroke frequently results in persistent lower limb motor impairment affecting gait and functional mobility (1-2). While video-based therapies have shown proof of concept for upper limb rehabilitation after stroke, their effectiveness for lower limb motor recovery remains insufficiently documented (3-5).
This study is a single-center pilot trial using a Single-Case Experimental Design (SCED) with multiple baseline durations, chosen to account for the high interindividual variability observed in subacute and chronic post-stroke patients undergoing rehabilitation (6). This design allows each participant to serve as their own control through repeated measurements over time (6).
Participants are included between 1 month and 1 year post-stroke while receiving inpatient or outpatient rehabilitation in a Physical Medicine and Rehabilitation department. All participants initially undergo a control phase combining standardized rehabilitation with sham video therapy (placebo condition). The duration of this baseline phase is randomized (1, 2, or 3 weeks) across participants.
The experimental phase consists of 5 weeks of intensive video therapy added to usual care, with five sessions per week. A post-intervention sham phase is followed by a follow-up period lasting up to 21 weeks post-intervention, with repeated assessments conducted at weeks 13, 17, and 21 to evaluate maintenance of treatment effects.
The primary objective is to evaluate changes in functional mobility, assessed using repeated measurements of the Timed Up and Go test. Secondary objectives include evaluation of gait endurance, motor impairment, muscle tone, balance, and quality of life
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: Active Videotherapy, Device: Sham videotherapy1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy. |
| Sequence 2 | Experimental | Device: Active Videotherapy, Device: Sham videotherapy2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy. |
| Sequence 3 | Experimental | Device: Active Videotherapy, Device: Sham videotherapy3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) , |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - First or recurrent hemispheric ischemic or hemorrhagic stroke in the subacute or chronic phase (from 1 month to 1 year post-stroke).
- Currently receiving rehabilitation care in a Physical Medicine and Rehabilitation (PM\&R) department
- Able to walk 3 meters back and forth, with or without an assistive device.
- Provided informed consent, signed jointly with the investigator.
Key exclusion criteria (7 listed)
- - Severe hemispatial neglect.
- Severe spasticity impairing proper positioning (Modified Ashworth Scale > 3).
- Severe general disabling medical conditions.
- Associated cerebellar syndrome.
- Major comprehension disorders, psychiatric illness, or cognitive impairments that could interfere with study participation.
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 |
|---|---|---|
| Active VideotherapyDuring active videotherapy sessions, the image inversion program is activated, superimposing movements of the non-paretic limb onto the paretic limb, which is hidden behind the screen. Participants are instructed to imagine and attempt to reproduce the observed movements using their paretic limb. Each participant completes 25 sessions over 5 weeks (5 sessions per week). | Device | Sequence 1, Sequence 2, Sequence 3 |
| Sham videotherapyDuring sham videotherapy sessions, participants are seated facing the IVS4 screen without activation of the image inversion program. Participants perform lower limb movements while directly viewing their paretic limb in real time on the screen, corresponding to an action observation condition without visual illusion. | Device | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
1. Timed Up and Go Test (TUG)
Time frame: 5-week
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
7 secondary outcomes
2. 2-Minute Walk Test (2MWT)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
3. Fugl-Meyer Assessment - Lower Limb Section
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
4. Muscle Strength - Foot Dorsiflexors and extensors
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
5. Muscle Tone - Modified Ashworth Scale (MAS)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
6. Muscle Tone - Modified Tardieu Scale
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
7. Postural Balance - PASS (Postural Assessment Scale for Stroke Patients)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
8. Quality of Life - Stroke Specific Quality of Life Scale (SS-QOL)
Time frame: Weeks 1, 2, 3, 8, 13, 17, and 21
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 13 Jul 2026.
- Individual participant dataSharing planned: No. This study has only 1 center
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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.
Etienne OJARDIAS, Dr principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Videotherapy in people with Hemiparetic Stroke, run by Centre Hospitalier Universitaire de Saint Etienne 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 4 inclusion and 7 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 13 Jul 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 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 Etienne OJARDIAS, Dr (0477127018 ext. 33, Etienne.Ojardias@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Timed Up and Go Test (TUG) (time frame: 5-week). 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 13 Jul 2026.