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Tele-CE in Severe Stroke

11 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60612
        • Reclutamento
        • Brain Plasticity Lab
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Tele-CE
Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Altro: 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.
Comparatore fittizio: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Walking speed
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Illinois at Chicago

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025-0207
  • 25PRE1372681 (Altro numero di sovvenzione/finanziamento: American Heart Association)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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