Brève description de l’étude (Source de données: BASEC)
Lo studio si prefigge di appurare per quanto tempo il robot per la riabilitazione della mano “ReHapticKnob” possa essere usato in modo autonomo all’interno di un centro di riabilitazione e se il dispositivo sia facile da usare.
Con il “ReHapticKnob” vengono eseguiti esercizi che allenano le funzioni motorie e sensoriali della mano in pazienti cha hanno subito un ictus cerebrale.
In particolare, durante questo studio vogliamo determinare se i partecipanti possono imparare a svolgere da soli gli esercizi con il robot “ReHapticKnob”, in modo da potersi esercitare anche autonomamente. Vogliamo testare se il robot è facile da usare e per quanto tempo i pazienti lo usano senza la supervisione di un terapista.
I partecipanti avranno due settimane di tempo per imparare ad utilizzare il robot con l'aiuto di un terapista. Dopo questa fase di allenamento, se ritenuti pronti, i partecipanti potranno svolgere gli esercizi anche senza la presenza di un terapista.
In questo modo, i pazienti potranno allenarsi di più, potenzialmente migliorando ulteriormente le funzionalità della mano lesa, e questo senza aumentare in modo eccessivo il carico di lavoro dei terapisti.
Maladies étudiées(Source de données: BASEC)
Ictus cerebrale
Health conditions
(Source de données: WHO)
Stroke
Maladie rare
(Source de données: BASEC)
Non
Intervention étudiée (p. ex., médicament, thérapie, campagne)
(Source de données: BASEC)
In questo studio viene esaminata l'esecuzione indipendente degli esercizi con il robot per la riabilitazione della mano ReHapticKnob. Con esecuzione indipendente si intende che il paziente si allena con l'aiuto del robot senza la supervisione diretta di un terapista.
Interventions
(Source de données: WHO)
Device: Minimally supervised therapy with the ReHapticKnob
Critères de participation à l’étude
(Source de données: BASEC)
1. Fase acuta/subacuta dell'ictus cerebrale, ovvero entro 6 settimane dall’ictus.
2. NIHSS ≥ 1 in almeno uno dei campi riguardanti funzioni motorie, sensoriali o atassia.
3. Pre-stroke modified rankin score (pre-mRS) ≤ 1.
Critères d’exclusion
(Source de données: BASEC)
1. Afasia moderata o grave: Goodglass-Kaplan scale < 3.
2. Deficit cognitivi moderati o gravi: LCF-R < 8.
3. Forti dolori nell’arto superiore paretico: VASp ≥ 5.
Inclusion/Exclusion Criteria
(Source de données: WHO)
Gender: All
Maximum age: 90 Years
Minimum age: 18 Years
Inclusion Criteria:
- Male and female stroke patients between 18 and 90 years old;
- pre-stroke Modified Rankin Score = 1;
- acute/subacute stroke (within (=) 6 weeks from onset);
- NIHSS = 1 in at least one of the items regarding motor function, sensory functions and
ataxia;
- the patient read, understood and signed the informed consent.
Exclusion Criteria:
- Modified Ashworth Scale > 2 for one or more of the following muscles: shoulder
adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and
fingers;
- moderate to severe aphasia: Goodglass-Kaplan scale < 3;
- moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R)
< 8;
- functional impairment of the upper limb due to other pathologies;
- severe pain in the affected arm: visual analogue scale for pain (VASp) = 5;
- other pathologies which may interfere with the study;
- pacemakers and other active implants.
-
Plus d’informations sur l’étude
Statut de recrutement
Completed
Titre scientifique
(Source de données: WHO)
Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot (ReHapticKnob): Pilot and Main Study
Type d’étude
(Source de données: WHO)
Interventional
Conception de l’étude
(Source de données: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase
(Source de données: WHO)
N/A
Points finaux primaires
(Source de données: WHO)
Compliance as assessed by dose
Points finaux secondaires
(Source de données: WHO)
Usability as assessed by the Post-Study System Usability Questionnaire;Usability as assessed by the System Usability Scale;Usability as assessed by the NASA Task Load Index;Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale;Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE);Change in upper limb functions as assessed by the ABILHAND;Change in upper limb functions as assessed by the Box and Block (BBT) test;Change in upper limb functions as assessed by the Motor Evaluation Scale for Upper Extremities in Stroke Patients (MESUPES);Change in upper limb functions as assessed by the modified Ashworth Scale (mAS);Change in the active Range of Motion (aROM) for grasping as assessed by a custom robotic assessment;Change in the active Range of Motion (aROM) for forearm rotation as assessed by a custom robotic assessment;Change in hand proprioception as assessed by a custom robotic assessment measuring the minimum difference in length that a patient can perceive;Change in haptic perception as assessed by a custom robotic assessment measuring the minimum difference in stiffness that a patient can perceive;Monitoring of muscle tone;Change in knowledge about stroke and health as assessed by a custom questionnaire consisting of 20 open or multiple-choice questions about stroke and health
Contact pour informations
(Source de données: WHO)
Please refer to primary and secondary sponsors
Résultats de l’étude
(Source de données: WHO)
Résumé des résultats
pas encore d’informations disponibles
Lien vers les résultats dans le registre primaire
pas encore d’informations disponibles
Informations sur la disponibilité des données individuelles des participants
pas encore d’informations disponibles
Lieux de réalisation des études
Lieux de réalisation des études en Suisse
(Source de données: BASEC)
Brissago
Pays où sont réalisées les études
(Source de données: WHO)
Switzerland
Contact pour plus d’informations sur l’étude
Données sur la personne de contact en Suisse
(Source de données: BASEC)
Giada Devittori
+41 44 510 72 31
giada.devittori@hest.ethz.ch
Contact pour des informations générales
(Source de données: WHO)
Paolo Rossi, Dr. med.
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
Contact pour des informations scientifiques
(Source de données: WHO)
Paolo Rossi, Dr. med.
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
Autorisation de la commission d’éthique (Source de données: BASEC)
Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)
Comitato etico cantonale Ticino
Date d’autorisation de la commission d’éthique
24.02.2020
Plus de numéros d’identification d’étude
Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID)
(Source de données: BASEC)
2020-00179
Secondary ID (Source de données: WHO)
ReHapticKnob 2020
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