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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 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

22

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Italia
    • Italy
      • Negrar, Italy, Italia, 37024
        • Reclutamiento
        • IRCCS Sacro Cuore Don Calabria Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Rehabilitation treatment with IVS before step training using an exoskeleton
Dispositivo: 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.
Comparador activo: Rehabilitation treatment with step training using an exoskeleton
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Revised Nottingham Sensory Assessment Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

IRCCS Sacro Cuore Don Calabria di Negrar

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de abril de 2024

Finalización primaria (Estimado)

30 de septiembre de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Publicado por primera vez (Actual)

6 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2023-41

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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