Tele-CE in Severe Stroke
11 juin 2026 mis à jour par: 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).
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60612
- Recrutement
- Brain Plasticity Lab
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Contact:
- Shravni Deshmukh
- Numéro de téléphone: 312-996-9056
- E-mail: sdeshm20@uic.edu
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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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|
Comparateur factice: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Délai: 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)
Délai: 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).
|
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Cutaneous reflex excitability using peripheral nerve stimulation (PNS)
Délai: 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.
|
Changes will be calculated from baseline (pre) to immediately after the intervention (post).
|
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Muscle Strength
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Walking speed
Délai: 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
Délai: 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).
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Physical activity levels
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2027
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
11 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-0207
- 25PRE1372681 (Autre subvention/numéro de financement: American Heart Association)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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