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Terapia asistida por robot para miembros superiores en pacientes con síndrome de Guillain-Barré (RAUL-Project)

15 de septiembre de 2026 actualizado por: I.R.C.C.S. Fondazione Santa Lucia

Efectos de la terapia asistida por robot para la recuperación funcional de las extremidades superiores en pacientes con síndrome de Guillain-Barré: un ensayo controlado aleatorio

Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.

The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with GBS.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome. A double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. This approach will help maintain participant blinding. Patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. Evaluations will include muscle recruitment and autonomy in daily living activities.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

62

Fase

  • Fase 4

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.

Ubicaciones de estudio

    • Lazio
      • Rome, Lazio, Italia, 00179
        • IRCCS Santa Lucia Foundation

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:

  1. Diagnosis of Guillan-Barré Syndrome;
  2. UL motor impairment (0-4 in the Medical Research Council scale);
  3. sub-acute phase (until 180 days);
  4. Patients able to maintain the sitting position.

Exclusion Criteria:

  1. Concomitant neurological, orthopedic, metabolic, and oncological diseases;
  2. Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
  3. Visual deficit;
  4. Hearing disorders.

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Active-assisted therapy with an upper limb robotic exoskeleton

Patients will receive upper limb neurorehabilitation training using a robotic exoskeleton administered by the therapist. The assistance provided by the device is adjusted based on the maximum force (as a percentage of the upper limb's weight) the robot needs to exert to assist the patient's movements. The computer-robot interface is designed to offer various exergames that require specific upper limb movements.

All movements performed by the patient using the exoskeleton will provide immediate audiovisual feedback on the computer screen. The training will consist of 20 sessions, with five 45-minute sessions per week.

Patients will undergo 20 session of 45 minutes each with an exoskeleton for upper limb rehabilitation. The assistance provided by the device is adjusted based on the maximum force (as a percentage of the upper limb's weight) the robot needs to exert to assist the patient's movements. Each session will include exercises designed to improve the range of motion (ROM) of the shoulder, elbow, wrist, and enhance hand coordination. The training parameters, such as difficulty level, duration, and visual stimuli, will be adjusted based on the patient's residual abilities. The selected exercises may involve movements of a single joint along one axis, combined movements of a single joint around 2 or 3 axes, selective exercises for the opening and closing hand, or multi-joint exercises. All exercises will be realized with audiovisual feedback.

Comparador activo: Passive mobilization with an upper limb robotic exoskeleton

Patients will undergo a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist.

Patients will undergo 20 session of 45 minute of a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist. This will involve passive mobilization using the exoskeleton for the upper limb, without any audiovisual feedback. They will not realize any active movement during the training.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

THE FMAUE will be used to assess the change in the motor and sensory functions of the upper limb. The FMAUE included five domains: motor functioning, sensitivity, coordination, range of motion and pain. The score ranging from 0 to 66 points, a higher score corresponds to a better function of the upper limb.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The 36-Item Short-Form Health Survey (SF-36)
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

The SF-36 will be used to assess the change in health-related quality of life. The SF-36 is organized into 8 different domains that are divided into physical components (Physical functioning, limitations due to physical problems, bodily pain and general perceptions of health status) and mental components (Social functioning, general mental health, limitations due to emotional problems and vitality). Each of the 8 domain scores, added together, is linearly transformed on a scale from 0 to 100, where 0 equals negative health and 100 equals positive health.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
modified Barthel Index (mBI)
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

The mBI will be used to assess the change in the autonomy of patients during their activities of daily living. This scale has a score ranging from 0 to 100 points, a higher score corresponds to a better performance in the activities of daily living.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
ABILHAND
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

The ABILHAND will be used to assess manual dexterity. The ABILHAND is a questionnaire-based assessment tool that measures the difficulty a patient perceives in using their hands to perform manual operations and activities in daily living. It assesses upper limb functionality. It has nonlinear logit values ranging from 1.72 to -2.18.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The Medical Research Council scale (MRC)
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

The MRC will be used to assess muscle strength. The score ranges from 0 to 5 where 0 equals no muscle recruitment and 5 normal muscle force.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The nine hole peg test (NHPG).
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

The NHPG will be used to assess fine manual dexterity. The NHPT consists of a square board with 9 pegs. At one end of the board are holes to insert the pegs, and at the other end is a shallow round plate to store the extracted pegs. The NHPT is administered by asking the patient to take the pegs from a container, one by one, and insert them into the holes on the board, as quickly as possible.

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
Grip strength
Periodo de tiempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Grip strength will be assessed using a manual digital dynamometer. The maximum strength of the whole hand will be recorded for three times without feedback (with the patient sitting with his back to the monitor).

Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Mini-Mental State Examination (MMSE)
Periodo de tiempo: T0 (Baseline)

MMSE is a widely used psychometric tool in clinical settings to assess cognitive function. It is employed to detect cognitive impairments, monitor the progression of neurodegenerative diseases such as Alzheimer disease, and evaluate the severity of cognitive decline.

The test consists of a series of questions and tasks that assess various cognitive domains, including orientation in time and space, memory, attention, language, and the ability to follow simple commands.

T0 (Baseline)

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Silla de estudio: Alex Martino Cinnera, PhD, IRCCS Santa Lucia Foundation
  • Silla de estudio: Diego Piatti, BSc, IRCCS Santa Lucia Foundation
  • Director de estudio: Laura Casagrande Conti, MSc, IRCCS Santa Lucia Foundation
  • Director de estudio: Martina D Arienzo, BSc, IRCCS Santa Lucia Foundation

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)

1 de octubre de 2024

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de septiembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2024

Publicado por primera vez (Actual)

1 de octubre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

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

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 110SL24

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Marco de tiempo para compartir IPD

2024/10/01

Criterios de acceso compartido de IPD

on resonable request to the study' PI

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO

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. .