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Tele-CE in Severe Stroke

11. juni 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Chicago, Illinois, Forente stater, 60612
        • Rekruttering
        • Brain Plasticity Lab
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Tele-CE
Skilled dorsiflexion and plantarflexion movements of the unaffected ankle using a tablet-based system to play simple and engaging games.
Annen: 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.
Sham-komparator: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Corticomotor excitability using transcranial magnetic stimulation (TMS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Walking speed
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Illinois at Chicago

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2025-0207
  • 25PRE1372681 (Annet stipend/finansieringsnummer: American Heart Association)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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