- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
9 juni 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
34
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Ticino
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Brissago, Ticino, Schweiz, 6614
- Clinica Hildebrand Centro di riabilitazione Brissago
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
Andra namn:
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Aktiv 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Motor impairment of the upper limb
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Motor impairment of the upper limb
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Change from Baseline in attention at 6 months
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Attention is assessed with the test to identify attention
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Change from Baseline in attention at 6 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Roger Gassert, Prof. Dr., Rehabilitation Engineering Lab, ETH Zurich
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2013
Primärt slutförande (Faktisk)
10 mars 2017
Avslutad studie (Faktisk)
9 juni 2017
Studieregistreringsdatum
Först inskickad
19 mars 2014
Först inskickad som uppfyllde QC-kriterierna
21 mars 2014
Första postat (Uppskatta)
26 mars 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
12 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2017
Senast verifierad
1 juni 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CIV-13-02-009921
- 2013-MD-0002 (Annan identifierare: Swissmedic)
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