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Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

9 giugno 2017 aggiornato da: Roger Gassert
The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

34

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Ticino
      • Brissago, Ticino, Svizzera, 6614
        • Clinica Hildebrand Centro di riabilitazione Brissago

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 90 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • age between 18-90 years old
  • hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke
  • sub-acute lesion not more than 6 weeks post ictus

Exclusion Criteria:

  • insufficient state of consciousness
  • severe aphasia
  • severe cognitive deficits
  • severe pathologies of the upper extremity of traumatic or rheumatic nature
  • severe pain in the affected arm
  • Patients with pacemakers and other active implants

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Robot group

Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.

(4 x 45 min/week)

2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Altri nomi:
  • Rehabilitation robot ReHapticKnob
Comparatore attivo: Control group
Receive dose-matched conventional neurocognitive therapy
Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
Altri nomi:
  • Perfetti-concept

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor impairment of the upper limb
Lasso di tempo: Change from Baseline in motor impairment of the upper limb at 4 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 4 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor impairment of the upper limb
Lasso di tempo: Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb
Lasso di tempo: Change from Baseline in motor impairment of the upper limb at 6 months
Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points)
Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity
Lasso di tempo: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity
Lasso di tempo: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity
Lasso di tempo: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Functional improvement in dexterity is assessed with the Box and Block Test
Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb
Lasso di tempo: Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb
Lasso di tempo: Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb
Lasso di tempo: Change from Baseline in spasticity level of the upper limb at 6 months
Spasticity level is measured with the Modified Ashworth Scale
Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb
Lasso di tempo: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
Tactile and proprioceptive sensory function of the upper limb
Lasso di tempo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
Tactile and proprioceptive sensory function of the upper limb
Lasso di tempo: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect
Lasso di tempo: Change from Baseline in neglect at 4 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 4 weeks
Neglect
Lasso di tempo: Change from Baseline in neglect at 8 weeks
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 8 weeks
Neglect
Lasso di tempo: Change from Baseline in neglect at 6 months
Neglect is assessed with the Albert's test of neglect
Change from Baseline in neglect at 6 months
Cognitive impairment
Lasso di tempo: Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
Lasso di tempo: Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
Lasso di tempo: Change from Baseline in cognitive impairment at 6 months
Cognitive impairment is assessed with the Mini Mental State Examination
Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
Lasso di tempo: Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
Lasso di tempo: Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
Lasso di tempo: Change from Baseline in frontal lobe function at 6 months
Frontal lobe function is assessed with the Frontal assessment battery
Change from Baseline in frontal lobe function at 6 months
Aphasia
Lasso di tempo: Change from Baseline in aphasia at 4 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 4 weeks
Aphasia
Lasso di tempo: Change from Baseline in aphasia at 8 weeks
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 8 weeks
Aphasia
Lasso di tempo: Change from Baseline in aphasia at 6 months
Aphasia is assessed with the Aachener Aphasia Test
Change from Baseline in aphasia at 6 months
Attention
Lasso di tempo: Change from Baseline in attention at 4 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 4 weeks
Attention
Lasso di tempo: Change from Baseline in attention at 8 weeks
Attention is assessed with the test to identify attention
Change from Baseline in attention at 8 weeks
Attention
Lasso di tempo: Change from Baseline in attention at 6 months
Attention is assessed with the test to identify attention
Change from Baseline in attention at 6 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Investigatori

  • Direttore dello studio: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2013

Completamento primario (Effettivo)

10 marzo 2017

Completamento dello studio (Effettivo)

9 giugno 2017

Date di iscrizione allo studio

Primo inviato

19 marzo 2014

Primo inviato che soddisfa i criteri di controllo qualità

21 marzo 2014

Primo Inserito (Stima)

26 marzo 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 giugno 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2017

Ultimo verificato

1 giugno 2017

Maggiori informazioni

Termini relativi a questo studio

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 .

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