Terapia assistita da robot per l'arto superiore in pazienti con sindrome di Guillain-Barré (RAUL-Project)
Effetti della terapia assistita da robot per il recupero funzionale dell'arto superiore in pazienti con sindrome di Guillain-Barré: uno studio randomizzato e controllato
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Lazio
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Rome, Lazio, Italia, 00179
- IRCCS Santa Lucia Foundation
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Diagnosis of Guillan-Barré Syndrome;
- UL motor impairment (0-4 in the Medical Research Council scale);
- sub-acute phase (until 180 days);
- Patients able to maintain the sitting position.
Exclusion Criteria:
- Concomitant neurological, orthopedic, metabolic, and oncological diseases;
- Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
- Visual deficit;
- Hearing disorders.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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. |
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Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The 36-Item Short-Form Health Survey (SF-36)
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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modified Barthel Index (mBI)
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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ABILHAND
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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The Medical Research Council scale (MRC)
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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The nine hole peg test (NHPG).
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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Grip strength
Lasso di tempo: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
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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).
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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Mini-Mental State Examination (MMSE)
Lasso di tempo: T0 (Baseline)
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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)
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Cattedra di studio: Alex Martino Cinnera, PhD, IRCCS Santa Lucia Foundation
- Cattedra di studio: Diego Piatti, BSc, IRCCS Santa Lucia Foundation
- Direttore dello studio: Laura Casagrande Conti, MSc, IRCCS Santa Lucia Foundation
- Direttore dello studio: Martina D Arienzo, BSc, IRCCS Santa Lucia Foundation
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi post-infettivi
- Malattie del sistema nervoso
- Processi patologici
- Malattie neuromuscolari
- Malattia cronica
- Attributi della malattia
- Malattie autoimmuni
- Malattie del sistema immunitario
- Malattie del sistema nervoso periferico
- Malattie autoimmuni del sistema nervoso
- Malattie demielinizzanti
- Polineuropatie
- Condizioni patologiche, segni e sintomi
- Poliradiculoneuropatia, demielinizzante infiammatoria cronica
- Poliradicoloneuropatia
- Sindrome di Guillain Barre
- Poliradicolopatia
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- 110SL24
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Periodo di condivisione IPD
2024/10/01
Criteri di accesso alla condivisione IPD
on resonable request to the study' PI
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .