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Powered Exoskeleton-Assisted Walking in Persons With Spinal Cord Injury

A legfontosabb adatok

Ki végzi
IRCCS San Raffaele Roma
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Befejeződött
Résztvevők
74 fő vett részt
Kezdés
2024. szept. 1.
Befejezés
2026. máj. 15.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • Wearable Powered Exoskeleton
A regiszteradat frissítve
2026. október 20.

Ki vehet részt

Életkor
18 év – 70 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 12 feltétel megnézéseKevesebb

Ki vehet részt

  • adults aged 18-70 years with a confirmed diagnosis of SCI
  • ability to maintain an upright posture for at least one minute
  • sufficient cardiovascular stability
  • ability to stand with double or single support, with or without supervision, or with a minimum-to-moderate level of therapist assistance, based on clinical judgment
  • inpatient or outpatient
  • clinically stable and with the pharmacological therapy unchanged throughout the observation period

Ki nem vehet részt

  • botulinum toxin in the previous 3 months and during the observation phase
  • neurological comorbidities
  • contraindications to exoskeleton use
  • cognitive deficits impairing comprehension or participation
  • severe comorbidities with relevance to cardiovascular function
  • physical limitations that prevented exoskeleton fitting

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A vizsgálatról

Mit akar kideríteni a vizsgálat

Spinal Cord Injury (SCI) represents a significant health challenge, particularly when it comes to the ability to walk. Among its many consequences, mobility impairment can not only directly impact quality of life but also cause a series of secondary problems, such as urinary tract problems, breathing difficulties, muscle contractures, joint stiffness, and resulting pain. These effects can manifest early, even at a young age, further increasing the physical and psychological burden of those affected.

A teljes eredeti leírásKevesebb

To address these challenges, the use of overground exoskeletons, such as the Ekso Bionics (USA), has attracted growing interest in both scientific research and clinical practice. The Ekso not only offers mobility but also represents a valuable resource for gait training, with potential direct and indirect benefits for the physical health and overall well-being of people with SCI. This study is a multicenter, retrospective, pre-post cohort study with the aim of evaluating the dose-dependent effects of exoskeleton-assisted walking training on level ground on spasticity and functional independence in individuals with spinal cord injury. The sample includes at least 70 participants with SCI underwed at least five sessions of walking training using the Ekso™ exoskeleton. Primary outcomes included changes in spasticity, measured by the aggregated Modified Ashworth Scale (MAS), and functional independence, assessed by the Spinal Cord Independence Measure (SCIM) III. The ultimate aim is therefore to evaluate whether ground-based exoskeleton-assisted gait training effectively reduces spasticity and improves functional independence in individuals with spinal cord injury, as this can support the integration of wearable motorized exoskeleons into standard spinal cord injury rehabilitation protocols.

A vizsgálat csoportja

  • Exoskeleton-Assisted Gait Training

    Individuals with spinal cord injury who underwent gait rehabilitation using the EksoGT wearable powered overground exoskeleton as part of their rehabilitation program. Outcomes were assessed before and after completion of training.

    Kezelés: Wearable Powered Exoskeleton

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Multicenter Retrospective Observational Study on Gait Training With a Powered Overground Exoskeleton in Persons With Spinal Cord Injury
A regiszteradat frissítve
2026. október 20.