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

1. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

.

Studientyp

Interventionell

Einschreibung (Geschätzt)

12

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Frankreich
      • Saint-Etienne, Frankreich, 42100
        • Service de Médecine Physique et réadaptation
        • Unterermittler:
          • Hugo BESSAGUET, MD
        • Unterermittler:
          • Julia TOULY, MD
        • Kontakt:
        • Unterermittler:
          • Pascal GIRAUX, MD, PhD
        • Hauptermittler:
          • Etienne OJARDIAS, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sequence 1
1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.
Gerät: 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).
Gerät: 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.
Gerät: 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).
Gerät: 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) ,
Gerät: 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).
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
2. 2-Minute Walk Test (2MWT)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Ermittler

  • Hauptermittler: Etienne OJARDIAS, Dr, Centre Hospitalier Universitaire de Saint Etienne

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Februar 2027

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

30. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

21. Januar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Juni 2026

Zuerst gepostet (Tatsächlich)

5. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 25CH169
  • 2025-A02102-47 (Andere Kennung: ANSM)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

This study has only 1 center

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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