- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9 czerwca 2017 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
34
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Ticino
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Brissago, Ticino, Szwajcaria, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 90 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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.
Inne nazwy:
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Aktywny 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.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Motor impairment of the upper limb
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Motor impairment of the upper limb
Ramy czasowe: 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
Ramy czasowe: 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
|
|
Functional improvement in dexterity
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
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Tactile and proprioceptive sensory function of the upper limb
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Change from Baseline in attention at 8 weeks
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Attention is assessed with the test to identify attention
|
Change from Baseline in attention at 8 weeks
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Attention
Ramy czasowe: 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
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 kwietnia 2013
Zakończenie podstawowe (Rzeczywisty)
10 marca 2017
Ukończenie studiów (Rzeczywisty)
9 czerwca 2017
Daty rejestracji na studia
Pierwszy przesłany
19 marca 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 marca 2014
Pierwszy wysłany (Oszacować)
26 marca 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
12 czerwca 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 czerwca 2017
Ostatnia weryfikacja
1 czerwca 2017
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CIV-13-02-009921
- 2013-MD-0002 (Inny identyfikator: Swissmedic)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .