StrokeNCT02096445
Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
A study testing robot-assisted neurocognitive therapy of hand function and Conventional neurocognitive rehabilitation in people with Stroke and Upper Extremity Paresis, run by Roger Gassert at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- robot-assisted neurocognitive therapy of hand function and Conventional neurocognitive rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2013to 9 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinica Hildebrand Centro di riabilitazione Brissago
Brissago, Canton Ticino, 6614
About this study
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.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- robot-assisted neurocognitive therapy of hand function, Conventional neurocognitive rehabilitation
- Keywords
- stroke, acute, rehabilitation, robot therapy, hand function, fine motor skills, neurocognitive, sensory, Perfetti, haptics
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted neurocognitive therapy of hand functionDevice
Also called Rehabilitation robot ReHapticKnob
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
Conventional neurocognitive rehabilitationOther
Also called Perfetti-concept
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot group | Experimental | Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy.
(4 x 45 min/week) Receives: Device: robot-assisted neurocognitive therapy of hand function |
| Control group | Active comparator | Receive dose-matched conventional neurocognitive therapy Receives: Other: Conventional neurocognitive rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor impairment of the upper limb
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)
Measured: Change from Baseline in motor impairment of the upper limb at 4 weeks
Secondary outcomes (26)
Motor impairment of the upper limb
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)
Measured: Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb
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)
Measured: Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Measured: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Measured: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity
Functional improvement in dexterity is assessed with the Box and Block Test
Measured: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Measured: Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Measured: Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb
Spasticity level is measured with the Modified Ashworth Scale
Measured: Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment
Measured: 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
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Measured: 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
Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment
Measured: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect
Neglect is assessed with the Albert's test of neglect
Measured: Change from Baseline in neglect at 4 weeks
Neglect
Neglect is assessed with the Albert's test of neglect
Measured: Change from Baseline in neglect at 8 weeks
Neglect
Neglect is assessed with the Albert's test of neglect
Measured: Change from Baseline in neglect at 6 months
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Measured: Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Measured: Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Measured: Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Measured: Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Measured: Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Measured: Change from Baseline in frontal lobe function at 6 months
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Measured: Change from Baseline in aphasia at 4 weeks
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Measured: Change from Baseline in aphasia at 8 weeks
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Measured: Change from Baseline in aphasia at 6 months
Attention
Attention is assessed with the test to identify attention
Measured: Change from Baseline in attention at 4 weeks
Attention
Attention is assessed with the test to identify attention
Measured: Change from Baseline in attention at 8 weeks
Attention
Attention is assessed with the test to identify attention
Measured: Change from Baseline in attention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2013
- Primary completion10 Mar 2017
- Study completion9 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roger Gassert
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roger Gassert, Swiss Federal Institute of Technology
- Investigators
- Roger Gassert, Prof. Dr., Study director, Rehabilitation Engineering Lab, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096445
- Sponsor's protocol ID
- CIV-13-02-009921
- Other IDs
- 2013-MD-0002
- Status last verified
- Jun 2017
- First submitted
- 19 Mar 2014
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24968378Ranzani 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.
PubMed 32831097Metzger 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.
PubMed 25399249
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke
- ClinicalTrials.gov ID
- NCT02096445
- Acronym / sponsor ID
- CIV-13-02-009921
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- stroke, acute, rehabilitation, robot therapy, hand function, fine motor skills, neurocognitive, sensory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Roger GassertUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 9 Jun 2017 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot group | Experimental | Device: robot-assisted neurocognitive therapy of hand functionReceive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week) |
| Control group | Active comparator | Other: Conventional neurocognitive rehabilitationReceive dose-matched conventional neurocognitive therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot-assisted neurocognitive therapy of hand functionAlso: Rehabilitation robot ReHapticKnob2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation. | Device | Robot group |
| Conventional neurocognitive rehabilitationAlso: Perfetti-conceptUse 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. | Other | Control group |
Primary outcome
Motor impairment of the upper limb
Time frame: 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)
26 secondary outcomes
Motor impairment of the upper limb
Time frame: Change from Baseline in motor impairment of the upper limb at 8 weeks
Motor impairment of the upper limb
Time frame: Change from Baseline in motor impairment of the upper limb at 6 months
Functional improvement in dexterity
Time frame: Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks
Functional improvement in dexterity
Time frame: Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks
Functional improvement in dexterity
Time frame: Change from Baseline in functional improvement of dexterity of the upper limb at 6 months
Spasticity level of the upper limb
Time frame: Change from Baseline in spasticity level of the upper limb at 4 weeks
Spasticity level of the upper limb
Time frame: Change from Baseline in spasticity level of the upper limb at 8 weeks
Spasticity level of the upper limb
Time frame: Change from Baseline in spasticity level of the upper limb at 6 months
Tactile and proprioceptive sensory function of the upper limb
Time frame: 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
Time frame: 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
Time frame: Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months
Neglect
Time frame: Change from Baseline in neglect at 4 weeks
Neglect
Time frame: Change from Baseline in neglect at 8 weeks
Neglect
Time frame: Change from Baseline in neglect at 6 months
Cognitive impairment
Time frame: Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
Time frame: Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
Time frame: Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
Time frame: Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
Time frame: Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
Time frame: Change from Baseline in frontal lobe function at 6 months
Aphasia
Time frame: Change from Baseline in aphasia at 4 weeks
Aphasia
Time frame: Change from Baseline in aphasia at 8 weeks
Aphasia
Time frame: Change from Baseline in aphasia at 6 months
Attention
Time frame: Change from Baseline in attention at 4 weeks
Attention
Time frame: Change from Baseline in attention at 8 weeks
Attention
Time frame: Change from Baseline in attention at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Results publication: PubMed 24968378Metzger 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.
- Derived from this study: PubMed 32831097Ranzani 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.
- Derived from this study: PubMed 25399249Metzger 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.
- Homepage of the investigator's laboratoryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Gassert, Prof. Dr. study director
Rehabilitation Engineering Lab, ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted neurocognitive therapy of hand function and Conventional neurocognitive rehabilitation in people with Stroke and Upper Extremity Paresis, run by Roger Gassert at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor impairment of the upper limb (time frame: Change from Baseline in motor impairment of the upper limb at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096445, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.