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Tele-CE in Severe Stroke

11 de junho de 2026 atualizado 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).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • Brain Plasticity Lab
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Outro: Tele-CE
Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Outro: Tele-CE
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.
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.
Outro: Tele-Control
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Transcallosal Inhibition using transcranial magnetic stimulation (TMS)
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Cutaneous reflex excitability using peripheral nerve stimulation (PNS)
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Peripheral nerve stimulation (PNS) will be used to assess the cutaneous reflexes excitability from the deep peroneal nerve.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Muscle Strength
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
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.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Walking speed
Prazo: 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.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Walking endurance
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Participants will perform 6-minute walk test (6MWT) to measure endurance.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Physical activity levels
Prazo: Changes will be calculated from baseline (pre) to immediately after the intervention (post).
The investigators will use an activity monitor to measure daily step count and moderate to vigorous physical activity percent.
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
Intervention acceptability
Prazo: Feedback will be collected immediately after the intervention (post).
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.
Feedback will be collected immediately after the intervention (post).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Illinois at Chicago

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de junho de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de junho de 2026

Primeira postagem (Real)

17 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

17 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

11 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2025-0207
  • 25PRE1372681 (Número de outro subsídio/financiamento: American Heart Association)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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