- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9. Juni 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
34
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Ticino
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Brissago, Ticino, Schweiz, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
Andere Namen:
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Aktiver Komparator: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Motor impairment of the upper limb
Zeitfenster: Change from Baseline in motor impairment of the upper limb at 4 weeks
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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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Motor impairment of the upper limb
Zeitfenster: Change from Baseline in motor impairment of the upper limb at 8 weeks
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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
Zeitfenster: Change from Baseline in motor impairment of the upper limb at 6 months
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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 6 months
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Functional improvement in dexterity
Zeitfenster: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
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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 4 weeks
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Functional improvement in dexterity
Zeitfenster: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
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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 8 weeks
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Functional improvement in dexterity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from Baseline in spasticity level of the upper limb at 8 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 8 weeks
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Spasticity level of the upper limb
Zeitfenster: Change from Baseline in spasticity level of the upper limb at 6 months
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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 6 months
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Tactile and proprioceptive sensory function of the upper limb
Zeitfenster: 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
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Tactile and proprioceptive sensory function of the upper limb
Zeitfenster: 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
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks
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Tactile and proprioceptive sensory function of the upper limb
Zeitfenster: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
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Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
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Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
|
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Neglect
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Change from Baseline in cognitive impairment at 8 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 8 weeks
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Cognitive impairment
Zeitfenster: Change from Baseline in cognitive impairment at 6 months
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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 6 months
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Frontal lobe function
Zeitfenster: Change from Baseline in frontal lobe function at 4 weeks
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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
Zeitfenster: Change from Baseline in frontal lobe function at 8 weeks
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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
Zeitfenster: Change from Baseline in frontal lobe function at 6 months
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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
Zeitfenster: Change from Baseline in aphasia at 4 weeks
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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
Zeitfenster: Change from Baseline in aphasia at 8 weeks
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 8 weeks
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Aphasia
Zeitfenster: Change from Baseline in aphasia at 6 months
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Aphasia is assessed with the Aachener Aphasia Test
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Change from Baseline in aphasia at 6 months
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Attention
Zeitfenster: Change from Baseline in attention at 4 weeks
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 4 weeks
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Attention
Zeitfenster: Change from Baseline in attention at 8 weeks
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 8 weeks
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Attention
Zeitfenster: Change from Baseline in attention at 6 months
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Attention is assessed with the test to identify attention
|
Change from Baseline in attention at 6 months
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. April 2013
Primärer Abschluss (Tatsächlich)
10. März 2017
Studienabschluss (Tatsächlich)
9. Juni 2017
Studienanmeldedaten
Zuerst eingereicht
19. März 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. März 2014
Zuerst gepostet (Schätzen)
26. März 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
12. Juni 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juni 2017
Zuletzt verifiziert
1. Juni 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CIV-13-02-009921
- 2013-MD-0002 (Andere Kennung: Swissmedic)
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