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

1. juni 2026 opdateret af: Arnauld GARCIN, Centre Hospitalier Universitaire de Saint Etienne

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Frankrig
      • Saint-Etienne, Frankrig, 42100
        • Service de Médecine Physique et réadaptation
        • Underforsker:
          • Hugo BESSAGUET, MD
        • Underforsker:
          • Julia TOULY, MD
        • Kontakt:
        • Underforsker:
          • Pascal GIRAUX, MD, PhD
        • Ledende efterforsker:
          • Etienne OJARDIAS, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence 1
1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.
Enhed: 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).
Enhed: 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.
Eksperimentel: Sequence 2
2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.
Enhed: 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).
Enhed: 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.
Eksperimentel: Sequence 3
3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,
Enhed: 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).
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1. Timed Up and Go Test (TUG)
Tidsramme: 5-week
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
5-week

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2. 2-Minute Walk Test (2MWT)
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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)
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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)
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
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)
Tidsramme: Weeks 1, 2, 3, 8, 13, 17, and 21
Quality of life assessed with the SS-QOL scale (score range: 49-245).
Weeks 1, 2, 3, 8, 13, 17, and 21

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Efterforskere

  • Ledende efterforsker: Etienne OJARDIAS, Dr, Centre Hospitalier Universitaire de Saint Etienne

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. februar 2027

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. juni 2028

Datoer for studieregistrering

Først indsendt

21. januar 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 25CH169
  • 2025-A02102-47 (Anden identifikator: ANSM)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

This study has only 1 center

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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