- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9. června 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Typ studie
Intervenční
Zápis (Aktuální)
34
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Ticino
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Brissago, Ticino, Švýcarsko, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 90 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Aktivní komparátor: Control group
Receive dose-matched conventional neurocognitive therapy
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Motor impairment of the upper limb
Časové okno: 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)
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Change from Baseline in motor impairment of the upper limb at 4 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Motor impairment of the upper limb
Časové okno: 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)
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Change from Baseline in motor impairment of the upper limb at 8 weeks
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Motor impairment of the upper limb
Časové okno: 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
Časové okno: 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
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Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
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Functional improvement in dexterity
Časové okno: 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
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Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
|
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Functional improvement in dexterity
Časové okno: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
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Functional improvement in dexterity is assessed with the Box and Block Test
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Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
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Spasticity level of the upper limb
Časové okno: Change from Baseline in spasticity level of the upper limb at 4 weeks
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Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 4 weeks
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Spasticity level of the upper limb
Časové okno: Change from Baseline in spasticity level of the upper limb at 8 weeks
|
Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 8 weeks
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Spasticity level of the upper limb
Časové okno: Change from Baseline in spasticity level of the upper limb at 6 months
|
Spasticity level is measured with the Modified Ashworth Scale
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Change from Baseline in spasticity level of the upper limb at 6 months
|
|
Tactile and proprioceptive sensory function of the upper limb
Časové okno: Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks
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Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
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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
Časové okno: 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
Časové okno: 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
|
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Neglect
Časové okno: Change from Baseline in neglect at 4 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 4 weeks
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Neglect
Časové okno: Change from Baseline in neglect at 8 weeks
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 8 weeks
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Neglect
Časové okno: Change from Baseline in neglect at 6 months
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Neglect is assessed with the Albert's test of neglect
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Change from Baseline in neglect at 6 months
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Cognitive impairment
Časové okno: Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 4 weeks
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Cognitive impairment
Časové okno: Change from Baseline in cognitive impairment at 8 weeks
|
Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 8 weeks
|
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Cognitive impairment
Časové okno: Change from Baseline in cognitive impairment at 6 months
|
Cognitive impairment is assessed with the Mini Mental State Examination
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Change from Baseline in cognitive impairment at 6 months
|
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Frontal lobe function
Časové okno: Change from Baseline in frontal lobe function at 4 weeks
|
Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 4 weeks
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Frontal lobe function
Časové okno: Change from Baseline in frontal lobe function at 8 weeks
|
Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 8 weeks
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Frontal lobe function
Časové okno: Change from Baseline in frontal lobe function at 6 months
|
Frontal lobe function is assessed with the Frontal assessment battery
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Change from Baseline in frontal lobe function at 6 months
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Aphasia
Časové okno: Change from Baseline in aphasia at 4 weeks
|
Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 4 weeks
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Aphasia
Časové okno: Change from Baseline in aphasia at 8 weeks
|
Aphasia is assessed with the Aachener Aphasia Test
|
Change from Baseline in aphasia at 8 weeks
|
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Aphasia
Časové okno: Change from Baseline in aphasia at 6 months
|
Aphasia is assessed with the Aachener Aphasia Test
|
Change from Baseline in aphasia at 6 months
|
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Attention
Časové okno: 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
|
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Attention
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Metzger JC, Lambercy O, Califfi A, Conti FM, Gassert R. Neurocognitive robot-assisted therapy of hand function. IEEE Trans Haptics. 2014 Apr-Jun;7(2):140-9. doi: 10.1109/TOH.2013.72.
- Ranzani R, Lambercy O, Metzger JC, Califfi A, Regazzi S, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Neurocognitive robot-assisted rehabilitation of hand function: a randomized control trial on motor recovery in subacute stroke. J Neuroeng Rehabil. 2020 Aug 24;17(1):115. doi: 10.1186/s12984-020-00746-7.
- Metzger JC, Lambercy O, Califfi A, Dinacci D, Petrillo C, Rossi P, Conti FM, Gassert R. Assessment-driven selection and adaptation of exercise difficulty in robot-assisted therapy: a pilot study with a hand rehabilitation robot. J Neuroeng Rehabil. 2014 Nov 15;11:154. doi: 10.1186/1743-0003-11-154.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. dubna 2013
Primární dokončení (Aktuální)
10. března 2017
Dokončení studie (Aktuální)
9. června 2017
Termíny zápisu do studia
První předloženo
19. března 2014
První předloženo, které splnilo kritéria kontroly kvality
21. března 2014
První zveřejněno (Odhad)
26. března 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
12. června 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. června 2017
Naposledy ověřeno
1. června 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CIV-13-02-009921
- 2013-MD-0002 (Jiný identifikátor: Swissmedic)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .