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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Etienne OJARDIAS, Dr
- Número de teléfono: 33 0477127018
- Correo electrónico: Etienne.Ojardias@chu-st-etienne.fr
Ubicaciones de estudio
-
-
-
Saint-Etienne, Francia, 42100
- Reclutamiento
- Service de Médecine Physique et réadaptation
-
Sub-Investigador:
- Hugo BESSAGUET, MD
-
Sub-Investigador:
- Julia TOULY, MD
-
Contacto:
- Diana RIMAUD, PhD
- Número de teléfono: 33 04 77 12 04 67
- Correo electrónico: Diana.Rimaud@chu-st-etienne.fr
-
Sub-Investigador:
- Pascal GIRAUX, MD, PhD
-
Investigador principal:
- Etienne OJARDIAS, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Sequence 1
1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham 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).
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.
|
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).
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) ,
|
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).
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
1. Timed Up and Go Test (TUG)
Periodo de tiempo: 5-week
|
Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
|
5-week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
2. 2-Minute Walk Test (2MWT)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Etienne OJARDIAS, Dr, Centre Hospitalier Universitaire de Saint Etienne
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 25CH169
- 2025-A02102-47 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .