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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
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Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Etienne OJARDIAS, Dr
- Número de telefone: 33 0477127018
- E-mail: Etienne.Ojardias@chu-st-etienne.fr
Locais de estudo
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Saint-Etienne, França, 42100
- Recrutamento
- Service de Médecine Physique et réadaptation
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Subinvestigador:
- Hugo BESSAGUET, MD
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Subinvestigador:
- Julia TOULY, MD
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Contato:
- Diana RIMAUD, PhD
- Número de telefone: 33 04 77 12 04 67
- E-mail: Diana.Rimaud@chu-st-etienne.fr
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Subinvestigador:
- Pascal GIRAUX, MD, PhD
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Investigador principal:
- Etienne OJARDIAS, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Sequence 1
1 week of sham videotherapy , 5 weeks of intervention (active videotherapy) , 2 weeks of sham videotherapy.
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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.
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Experimental: Sequence 2
2 weeks of sham videotherapy , 5 weeks of intervention (active videotherapy) , 1 weeks of sham videotherapy.
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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.
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Experimental: Sequence 3
3 weeks of sham videotherapy and 5 weeks of intervention (active videotherapy) ,
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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1. Timed Up and Go Test (TUG)
Prazo: 5-week
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Time required to stand up from a chair, walk 3 meters, return, and sit down (in seconds)
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5-week
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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2. 2-Minute Walk Test (2MWT)
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Walking endurance assessed by the distance walked in 2 minutes (in meters).
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Weeks 1, 2, 3, 8, 13, 17, and 21
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3. Fugl-Meyer Assessment - Lower Limb Section
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Motor function of the hemiplegic lower limb, assessed with the Fugl-Meyer scale (score from 0 to 34)
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Weeks 1, 2, 3, 8, 13, 17, and 21
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4. Muscle Strength - Foot Dorsiflexors and extensors
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Muscle strength of the foot dorsiflexors and extensors, measured in Newtons using a handheld dynamometer
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Weeks 1, 2, 3, 8, 13, 17, and 21
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5. Muscle Tone - Modified Ashworth Scale (MAS)
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Ashworth Scale (score 0-5).
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Weeks 1, 2, 3, 8, 13, 17, and 21
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6. Muscle Tone - Modified Tardieu Scale
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Spasticity assessment of dorsiflexors and extensors of the foot using the Modified Tardieu Scale (score 0-5).
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Weeks 1, 2, 3, 8, 13, 17, and 21
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7. Postural Balance - PASS (Postural Assessment Scale for Stroke Patients)
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Balance ability assessed using the PASS scale (score 0-36).
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Weeks 1, 2, 3, 8, 13, 17, and 21
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8. Quality of Life - Stroke Specific Quality of Life Scale (SS-QOL)
Prazo: Weeks 1, 2, 3, 8, 13, 17, and 21
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Quality of life assessed with the SS-QOL scale (score range: 49-245).
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Weeks 1, 2, 3, 8, 13, 17, and 21
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Etienne OJARDIAS, Dr, Centre Hospitalier Universitaire de Saint Etienne
Datas de registro do estudo
Datas Principais do Estudo
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Enviado pela primeira vez que atendeu aos critérios de CQ
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Mais Informações
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Palavras-chave
Outros números de identificação do estudo
- 25CH169
- 2025-A02102-47 (Outro identificador: ANSM)
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