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Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology. (IVS)

30 septembre 2026 mis à jour par: IRCCS Sacro Cuore Don Calabria di Negrar

Experimental Pilot Study: Efficacy of Preparatory Treatment With Intensive Visual Simulation (IVS) Prior to Step Training With an Exoskeleton (EKSO) in Patients With Hemisensory Syndrome Resulting From Acquired Brain Injury of Vascular Etiology.

Clinical trial involving a medical device, not intended for CE marking, randomized, blinded to evaluate the efficacy of preparatory treatment with Intensive Visual Simulation 4 (IVS) prior to exoskeleton-assisted (EKSO) step training in achieving independent ambulation in hemiparetic patients with impaired proprioceptive sensation. Patients will be randomized into two groups: one group in which patients will undergo IVS treatment before physiotherapy and robotic step training with an exoskeleton; and one group in which patients will undergo only physiotherapy and robotic step training with an exoskeleton.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Enrolled patients will be randomized to one of the two rehabilitation treatment arms included in the trial.

  • Arm A: Rehabilitation treatment with IVS before physiotherapy-based and robotic gait training using an exoskeleton.
  • Arm B: Rehabilitation treatment with physiotherapy-based and robotic step training using an exoskeleton.

Training will last:

  • 15 minutes of IVS (only for Arm A)
  • 30 minutes of EKSO training (which in Arm A will be performed after IVS treatment)
  • 45 minutes of non-robotic motor therapy following robotic treatment.

Each rehabilitation session will last a maximum of approximately 1.5 hours and will be repeated 5 days a week for 3 weeks.

Clinical evaluations will be conducted by a physician who is unaware of the rehabilitation treatment the patient has undergone (the patient will be appropriately informed of the need not to disclose the type of rehabilitation received to the evaluating physician).

Type d'étude

Interventionnel

Inscription (Estimé)

22

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.

Coordonnées de l'étude

Lieux d'étude

  • Italie
    • Italy
      • Negrar, Italy, Italie, 37024
        • Recrutement
        • IRCCS Sacro Cuore Don Calabria Hospital
        • Contact:

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

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Male and female patients aged 18 to 80 years (both ends included).
  • Diagnosis of hemiparesis/plegia with proprioceptive sensory deficit due to a cerebrovascular event within the last 6 months
  • Orientation in the 3 domains (space, time, and person)
  • Cooperation
  • Clinical stability
  • Trunk control while standing
  • Signature of the Informed Consent Form for participation in the study and for the processing of personal data

Exclusion Criteria:

  • Patients aged < 18 years and > 80 years
  • Patients who are disoriented in at least one of the three domains (space, time, and person)
  • Non-cooperative patients
  • Patients with global aphasia
  • Patients with severe ideomotor apraxia
  • Patients with cognitive or mental disorders
  • Patients not eligible for EKSO:
  • Severe comorbid conditions: infections, circulatory, cardiac, or pulmonary diseases, pressure ulcers.
  • Severe spasticity (level 4 on the modified Ashworth scale).
  • Spinal instability or unhealed fractures of the limbs or pelvis.
  • Heterotopic ossification.
  • Psychiatric or cognitive conditions that may interfere with the proper use of the device.
  • Pregnant women.
  • Reduced tolerance for standing due to orthostatic hypotension.
  • Range of motion (ROM) limitations that would prevent the patient from achieving a normal bilateral gait pattern or performing normal transitions from a seated to a standing position and vice versa: Bilateral hip flexion less than 110°, knee flexion contracture greater than 12°, or inability to achieve neutral dorsiflexion of 0° with knee flexion up to 12°.
  • Leg length discrepancy greater than 1.27 cm for the upper leg and 1.9 cm for the lower leg.
  • Unresolved deep vein thrombosis.
  • Uncontrolled autonomic dysreflexia.
  • Lower limb prostheses.

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Rehabilitation treatment with IVS before step training using an exoskeleton
Dispositif: Rehabilitation treatment with IVS before step training using an exoskeleton
  • 15 minutes of IVS: The physical therapist will show the patient a pre-recorded sequence of movements and activities involving the lower limb. Patient will observe the movements on a screen positioned to cover the paretic limb and will then be ask to repeat them.
  • 30 minutes of EKSO training:The physical therapist will set up the training using a single program defined as "assistive" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required.
  • 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently.

The rehabilitation treatment session will be repeated 5 days a week for 3 weeks.
Comparateur actif: Rehabilitation treatment with step training using an exoskeleton
Dispositif: Rehabilitation treatment with step training using an exoskeleton
  • 30 minutes of EKSO training: The physical therapist will set up the training using a single program defined as "assistive" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required.
  • 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently.

The rehabilitation treatment session will be repeated 5 days a week for 3 weeks.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Délai: Baseline to Timepoint 1 (3 weeks after)

Scores on the Berg Balance Scale from baseline to the end of treatment. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.
Baseline to Timepoint 1 (3 weeks after)
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Délai: Baseline to Timepoint 1 (3 weeks after)

Scores on the Timed Up and Go test from baseline to the end of treatment. The test measures, in seconds, the time it takes a patient to stand up from a chair with armrests, walk 3 meters, turn around, walk back, and sit down again.
Baseline to Timepoint 1 (3 weeks after)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Revised Nottingham Sensory Assessment Scale Score
Délai: Baseline to Timepoint 2 (7 weeks after)

Revised Nottingham Sensory Assessment Scale Score for evaluating sensitivity in the paretic hemibody
Baseline to Timepoint 2 (7 weeks after)
Range of Motion (ROM) Values for the Tibiotarsal and Knee Joints
Délai: Baseline to Timepoint 2 (7 weeks after)

Range of Motion (ROM) Values for Assessment of the Tibiotarsal and Knee Joints
Baseline to Timepoint 2 (7 weeks after)
Presence/absence of tendon retractions
Délai: Baseline to Timepoint 2 (7 weeks after)

Presence/absence of tendon retractions in the knee and tibiotarsal flexor-extensor muscles and the tibiotarsal pronator-supinator muscles
Baseline to Timepoint 2 (7 weeks after)
Ashworth Scale (MAS)
Délai: Baseline to Timepoint 2 (7 weeks after)

Ashworth Scale (MAS) for Assessing Muscle Tone
Baseline to Timepoint 2 (7 weeks after)
Minimum number of sessions required to achieve independent walking with assistive devices
Délai: Baseline to Timepoint 1 (3 weeks after)

Evaluation of the minimum number of sessions required to achieve independent walking with assistive devices.
Baseline to Timepoint 1 (3 weeks after)
Percentage of assistance provided by EKSO
Délai: Baseline to Timepoint 2 (7 weeks after)

Percentage of assistance provided by EKSO as recorded by the machine after 10 minutes, after 20 minutes, and at the end of 30 minutes of robotic training.
Baseline to Timepoint 2 (7 weeks after)
Number of steps taken during a training session with EKSO
Délai: Baseline to Timepoint 2 (7 weeks after)

Number of steps taken during a single 30-minute training session with EKSO, as recorded by the machine.
Baseline to Timepoint 2 (7 weeks after)
Assessment of the maintenance of skills acquired through preparatory training, with or without Intensive Visual Simulation (IVS), for exoskeleton (EKSO) step training
Délai: Timepoint 2 (7 weeks after baseline)

Values after 7 weeks from the Timed Up and Go Test. The test measures, in seconds, the time it takes a patient to stand up from a chair with armrests, walk 3 meters, turn around, walk back, and sit down again.
Timepoint 2 (7 weeks after baseline)
Assessment of the maintenance of skills acquired through preparatory training, with or without Intensive Visual Simulation (IVS), for exoskeleton (EKSO) step training
Délai: At Timepoint 2 (7 weeks after baseline)

Values after 7 weeks from the Berg Balance Scale. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.
At Timepoint 2 (7 weeks after baseline)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

IRCCS Sacro Cuore Don Calabria di Negrar

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 (Réel)

21 avril 2024

Achèvement primaire (Estimé)

30 septembre 2027

Achèvement de l'étude (Estimé)

30 septembre 2027

Dates d'inscription aux études

Première soumission

15 septembre 2026

Première soumission répondant aux critères de contrôle qualité

30 septembre 2026

Première publication (Réel)

6 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2023-41

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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