Display again
SNCTP000003850 | NCT04388891 | BASEC2020-00179

Fattibilità in clinica della terapia minimamente supervisionata dopo ictus cerebrale con un robot per la riabilitazione della mano (ReHapticKnob): studio pilota e studio principale

Data source: BASEC (Imported from 21.01.2021), WHO (Imported from 17.01.2021)
Changed: 12.01.2021
Disease category: Nervous System diseases, Arterial and venous diseases including deep venous thrombosis and lung embolism, Brain diseases (non cancer)

Brief description of trial (Data source: 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.

Health conditions investigated (Data source: BASEC)

Ictus cerebrale

Health conditions (Data source: WHO)

Stroke

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: 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 (Data source: WHO)

Device: Minimally supervised therapy with the ReHapticKnob

Criteria for participation in trial (Data source: 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.

Exclusion criteria (Data source: 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 (Data source: WHO)


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.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT04388891

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT04388891

Further information on trial

Date trial registered

05.05.2020

Incorporation of the first participant

20.07.2020

Recruitment status

Recruiting

Academic title (Data source: WHO)

Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot (ReHapticKnob): Pilot and Main Study

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Compliance as assessed by dose

Secundary end point (Data source: WHO)

Monitoring of muscle tone;Change in haptic perception as assessed by a custom robotic assessment measuring the minimum difference in stiffness that a patient can perceive;Change in hand proprioception as assessed by a custom robotic assessment measuring the minimum difference in length that a patient can perceive;Change in the active Range of Motion (aROM) for forearm rotation as assessed by a custom robotic assessment;Change in the active Range of Motion (aROM) for grasping as assessed by a custom robotic assessment;Change in upper limb functions as assessed by the modified Ashworth Scale (mAS);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 Box and Block (BBT) test;Change in upper limb functions as assessed by the ABILHAND;Change in upper limb functions as assessed by the Fugl-Meyer Assessment of Upper Extremities (FMA-UE);Evolution of patient's satisfaction with robot-assisted therapy as assessed by a 5-point scale;Usability as assessed by the NASA Task Load Index;Usability as assessed by the System Usability Scale;Usability as assessed by the Post-Study System Usability Questionnaire

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Brissago

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Giada Devittori
+41 44 510 72 31
giada.devittori@hest.ethz.ch

Contact for general information (Data source: WHO)

Paolo Rossi, Dr. med.;Giada Devittori, M. Sc.
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
+41 44 510 72 31
giada.devittori@hest.ethz.ch

Contact for scientific information (Data source: WHO)

Paolo Rossi, Dr. med.;Giada Devittori, M. Sc.
CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO
+41 44 510 72 31
giada.devittori@hest.ethz.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Swiss Federal Institute of Technology

Additional sponsors (Data source: WHO)

CLINICA HILDEBRAND CENTRO DI RIABILITAZIONE BRISSAGO;Rehabilitation Engineering Laboratory, ETHZ

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Comitato etico cantonale Ticino

Date of authorisation by the ethics committee

24.02.2020

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2020-00179

Secondary ID (Data source: WHO)

ReHapticKnob 2020