Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke (SI-VI-MI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiparetic Stroke
• Intervention / Treatment: Device: Active Videotherapy; Device: Sham videotherapy

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 Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Etienne OJARDIAS, Dr; Phone Number: 33 0477127018; Email: Etienne.Ojardias@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42100
    • Service de Médecine Physique et réadaptation
    • Sub-Investigator: Hugo BESSAGUET, MD
    • Sub-Investigator: Julia TOULY, MD
    • Contact: Diana RIMAUD, PhD; Phone Number: 33 04 77 12 04 67; Email: Diana.Rimaud@chu-st-etienne.fr
    • Sub-Investigator: Pascal GIRAUX, MD, PhD
    • Principal Investigator: Etienne OJARDIAS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - 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.

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; 1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.	Device: Active Videotherapy; 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).; Device: Sham videotherapy; 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.
Experimental: Sequence 2; 2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.	Device: Active Videotherapy; 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).; Device: Sham videotherapy; 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.
Experimental: Sequence 3; 3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,	Device: Active Videotherapy; 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).; Device: Sham videotherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Timed Up and Go Test (TUG)	Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)	5-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. 2-Minute Walk Test (2MWT)	Walking endurance assessed by the distance walked in 2 minutes (in meters).	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)	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	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).	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).	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).	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).	Weeks 1, 2, 3, 8, 13, 17, and 21

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Etienne OJARDIAS, Dr, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Single case experimental design; Lower limb rehabilitation; Videotherapy; Hemiplegic/Hemiparetic
• Other Study ID Numbers: 25CH169; 2025-A02102-47 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study has only 1 center

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No