Tele-CE in Severe Stroke
11 de junio de 2026 actualizado por: Sangeetha Madhavan, University of Illinois at Chicago
Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke
The goal of this clinical trial is to determine the effects of home-based cross-education on lower limb neuroplasticity in severe stroke.
The main questions the investigators aim to answer are:
- What are the effects of home-based cross-education on lower limb neuroplasticity?
- What are the effects of home-based cross-education on lower limb function?
- Is home-based cross-education feasible to administer and accepted by participants?
Participants will take part in ten home-based, remotely supervised sessions, during which participants will either perform unilateral skill and strength training of the unaffected lower limb (Tele-Cross Education or Tele-CE) or cognitive training and unilateral movements of the unaffected lower limb (Tele-control). Each participant will experience measures of brain and spinal activity and motor function testing before and after both sessions (Tele-CE and Tele-control). Each participant will also be asked to fill out a feedback questionnaire to assess acceptability after intervention sessions (Tele-CE and Tele-control).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Reclutamiento
- Brain Plasticity Lab
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Contacto:
- Shravni Deshmukh
- Número de teléfono: 312-996-9056
- Correo electrónico: sdeshm20@uic.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Single, monohemispheric stroke
- Chronic stroke (> 6 months prior)
- Severe stroke (Fugl-Meyer Lower Extremity motor scale score < 21 or 6 Minute Walk Test distance < 300m)
Exclusion Criteria:
- Use of anti-spasticity medications
- Existence of other neurological disorders
- Have brainstem or cerebellar lesions.
- Mini-Mental State Examiniation score of <21, to ensure participants have the cognitive capacity to consent and can understand instructions both in-person and during remote supervision.
- Non-English-speaking individuals
- Bone, joint or soft tissue injury
- Uncontrolled medical conditions (such as uncontrolled hypertension, untreated cardiac disease, or untreated pulmonary disease)
- Unable to see the tablet and zoom screen
- Unable to move non-paretic ankle (< 5 degrees of ankle ROM)
- Fugl-Meyer Lower Extremity sensory scale score < 6
TMS exclusion criteria
- Previous adverse reaction to TMS
- Skull abnormalities or fractures
- Concussion within the prior 6 months
- Unexplained, recurring headaches
- Implanted cardiac pacemaker
- Metal implants in the head or face
- History of seizures or epilepsy
- Use of medications that could alter cortical excitability or increase risk of seizure (e.g., antidepressants, antipsychotics, anxiolytics, anticonvulsants)
- Current pregnancy
PNS exclusion criteria
- Skin hypersensitivity at any sites of stimulation, including the scalp, thoracolumbar spine, and peripheral limbs
- History of contact dermatitis at any of the sites of stimulation
- History of allodynia and/or hyperalgesia
- Active skin infection
- Skin lesions
- Deep vein thrombosis
- Any other skin or scalp condition that could be aggravated by stimulation
- Implanted electronic, metallic, or highly conductive devices near site of stimulation that cannot be removed without permission from a health professional
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Tele-Cross Education (Tele-CE)
While seated, participants will begin with 15 minutes of game-based ankle skill training of the unaffected lower limb.
Participants will perform skilled dorsiflexion and plantarflexion movements of the unaffected ankle to play simple and engaging games.
Three game blocks will be played (5 mins/block) with 1-minute rest between blocks.
Following this, participants will engage in unaffected leg strength training using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
Participants will perform 3 sets of 10 repetitions for each muscle group.
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Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Unilateral lower limb strength training of the unaffected leg using a theraband targeting hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
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Comparador falso: Tele-Control
While seated, participants will begin with 15 minutes of cognitive training using games focusing on memory and executive function.
Participants will play three cognitive games (5 minutes each with 1-min rest between blocks).
Following this, participants will engage in unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
Participants will perform 3 sets of 10 repetitions of movements for each muscle group.
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Cognitive training using games focusing on memory and executive function along with unilateral leg movements of the unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, and ankle plantarflexors.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Single-pulse transcranial magnetic stimulation (TMS) will be used to assess the corticomotor excitability from the tibialis anterior muscle.
Higher values indicate more corticomotor excitability.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Transcallosal Inhibition using transcranial magnetic stimulation (TMS)
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Inhibition from the stimulated hemisphere to the non-stimulated hemisphere will be quantified as a measure of the ipsilateral silent period (iSP) using single pulse transcranial magnetic stimulation (TMS) and motor evoked potentials (MEPs) will be recorded from the tibialis anterior muscle of the leg ipsilateral to TMS stimulation.
Higher values indicate more inhibition from the stimulated hemisphere to the non-stimulated hemisphere.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Cutaneous reflex excitability using peripheral nerve stimulation (PNS)
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Muscle Strength
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Muscle strength of the affected and unaffected hip flexors, hip abductors, hip adductors, knee flexors, knee extensors, ankle dorsiflexors and ankle plantarflexors will be measured using handheld dynamometry.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Walking speed
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
|
Participants will complete the 10-Meter Walk Test (10MWT) on a flat, unobstructed walkway to measure walking speed.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Walking endurance
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Participants will perform 6-minute walk test (6MWT) to measure endurance.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Physical activity levels
Periodo de tiempo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.
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Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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Intervention acceptability
Periodo de tiempo: Feedback will be collected immediately after the intervention (post).
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Acceptability will be assessed through one custom semi-structured patient feedback questionnaire that includes domains of perceived satisfaction.
Higher values indicate higher participant acceptability and perceived satisfaction of the intervention.
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Feedback will be collected immediately after the intervention (post).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025-0207
- 25PRE1372681 (Otro número de subvención/financiamiento: American Heart Association)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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