Tele-CE in Severe Stroke

Официальное название

Effect of Home-based Cross-education on Lower Limb Neuroplasticity in Severe Stroke

Обзор

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).

Вмешательства

• Другое Tele-CE
  Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Corticomotor excitability using transcranial magnetic stimulation (TMS) [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Transcallosal Inhibition using transcranial magnetic stimulation (TMS) [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Cutaneous reflex excitability using peripheral nerve stimulation (PNS) [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Muscle Strength [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]

Вторичные конечные точки (4)

• Walking speed [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Walking endurance [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Physical activity levels [Срок оценки: Changes will be calculated from baseline (pre) to immediately after the intervention (post).]
• Intervention acceptability [Срок оценки: Feedback will be collected immediately after the intervention (post).]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brain Plasticity Lab — Chicago

Идентификаторы

NCT: NCT07652970 · 2025-0207 · 25PRE1372681

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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