StrokeOnLINENCT04759976
Optimize Motor Learning to Improve Neurorehabilitation
A study testing Robotic motor training in people with Stroke and Neurologic Disorder, run by University of Bern at 1 site in Switzerland.
Trial summary
The objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. For this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Neurologic Disorder
- What is being tested?
- Robotic motor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jan 2019to 16 Oct 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Informed Consent as documented by signature ("Informed Consent" form)
- Bodyweight <120 kg
- Ability to communicate effectively with the examiner so that the validity of the patient's data could not be compromised
Who cannot join
- Excessive spasticity of the affected arm (Ashworth Scale ≥3)
- Serious medical or psychiatric disorder
- Orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
- Shoulder subluxation
- Skin ulcerations at the paretic arm
- Cyber-sickness (i.e., nausea when looking at a screen or playing computer games)
- Serious cognitive defects or aphasia preventing effective use of the robotic devices
- Severe visual and auditory impairments
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. For this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. Patients have a diagnosis of a neurological disease (i.e., stroke, spinal cord injury, multiple sclerosis, Guillain-Barré syndrome) limiting arm motor function.
Read the detailed description
Neurological patients (e.g., after stroke) engage in intensive and expensive neurorehabilitation therapy to regain part of their former motor functional ability to perform everyday activities with often limited and unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation therapy, providing cost-effective, high repetition and task-oriented training. However, results of an initial body of work comparing the effectiveness of robotic training strategies are highly inconclusive. A possible explanation is that most current robotic systems cover only one neurorehabilitation strategy (e.g. reducing or augmenting movement errors) and may thus insufficiently address the subjects' individual needs and the characteristics of the task to be learned. In this study, Investigators will perform several motor learning experiments with healthy adult and neurological patients in order to evaluate the relative motor and cognitive benefits of newly developed robotic training strategies that modulate errors based on the subject's age, skill level and tasks characteristics. The effects of the new strategies will be compared to classical robotic assistance, and to non-robotic feedback approaches, such as visual feedback. The culmination of this work may help to optimize training benefits of already existing rehabilitation robots.
- Conditions
- Stroke, Neurologic Disorder
- Being tested
- Robotic motor training
- Keywords
- Neurorehabilitation, Robotic Rehabilitation, Motor Learning
- Medical subject headings
- Stroke, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic motor trainingBehavioural
The experiments consist in performing motor tasks with upper-limb robotic devices.
| Study group | Role | What they receive |
|---|---|---|
| Robotic motor training | Experimental | Participants will perform motor tasks (i.e. movements) with upper limb robotic devices applying different strategies (e.g. supporting or challenging the subject, or being fully compliant). Receives: Behavioral: Robotic motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kinematic performance assessed by the robot
Motion changes from baseline in the kinematic variables assessed by the robot and motion trackers during the motor learning task. The kinematic performance analysis consists of end-effector position in the x, y, and z-axis, in meters, and joint angles in degrees.
Measured: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Change in kinetic performance assessed by the robot
Force changes from baseline in the kinetic variables assessed by the robot using force sensors during the motor learning task. Kinetic performance analysis consists of interaction forces in x, y, and z-axis, in N and applied robot joint torques by the motors, in Nm.
Measured: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Spatial analysis of changes in evoked potentials as assessed by Electroencephalography (EEG) measurement
Electroencephalographical assessment of changes in evoked potentials i.e. the electrical activity of the brain in response to stimulation of specific sensory nerve pathways.
Measured: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Secondary outcomes (5)
Change in embodiment
Virtual Reality (VR) Embodiment Scale, Self administered Likert scale of 1-7 (Strongly Disagree to Strongly Agree)
Measured: Before Intervention, Immediately after the end of intervention
Spatial analysis of changes in Task-Based Brain Connectivity as assessed by Electroencephalography (EEG) measurement
Changes in Task-Based Brain Connectivity from baseline in electroencephalography measurement
Measured: Baseline, training (immediately after baseline or 1-2 days after baseline), retention (1-2 days after the training)
Change in Motivation as assessed by Intrinsic Motivation Inventory (IMI)
Intrinsic Motivation Inventory, Self administered. Likert scale of 1-7 (1: not at all true - 4: somewhat true - 7: very true)
Measured: Before Intervention, Immediately after the end of intervention, at the end of the session
Change in Cognitive Load as assessed by National Aeronautics and Space Administration (NASA) (Raw) Task Load Index
Self-reported cognitive load during a task, Self-administered National Aeronautics and Space Administration (Raw) Task Load Index (TLX), analog scale mapped from 0 to 100 (Endpoints: Low/High, Good/Poor)
Measured: Immediately after the end of intervention, At the end of the session
System Usability as assessed by System Usability Scale (SUS)
Self reported system usability assessed by System Usability Scale (SUS) Likert scale of 1-5 (Strongly agree to Strongly disagree)
Measured: Immediately after the end of intervention, At the end of the session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start25 Jan 2019
- Primary completion15 Apr 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Marchal-Crespo, Prof. Dr., Principal investigator, University of Bern, ARTORG Center for Biomedical Engineering Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759976
- Sponsor's protocol ID
- 2018-01179
- Other IDs
- 2018
- Acronym
- OnLINE
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2021
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication
Publications
Ozen O, Buetler KA, Marchal-Crespo L. Towards functional robotic training: motor learning of dynamic tasks is enhanced by haptic rendering but hampered by arm weight support. J Neuroeng Rehabil. 2022 Feb 13;19(1):19. doi: 10.1186/s12984-022-00993-w.
PubMed 35152897
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimize Motor Learning to Improve Neurorehabilitation
- ClinicalTrials.gov ID
- NCT04759976
- Acronym / sponsor ID
- OnLINE / 2018-01179
- Conditions
- Stroke, Neurologic Disorder
- Keywords
- Neurorehabilitation, Robotic Rehabilitation, Motor Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 18 Feb 2021 (actual)
- 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 objective of this study is to develop and evaluate novel robotic training strategies that modulate errors based on the subjects' individual motor and cognitive needs. For this purpose, healthy adults and neurologic patients will participate in robotic motor learning experiments. Patients have a diagnosis of a neurological disease (i.e., stroke, spinal cord injury, multiple sclerosis, Guillain-Barré syndrome) limiting arm motor function.
Detailed description
Neurological patients (e.g., after stroke) engage in intensive and expensive neurorehabilitation therapy to regain part of their former motor functional ability to perform everyday activities with often limited and unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation therapy, providing cost-effective, high repetition and task-oriented training. However, results of an initial body of work comparing the effectiveness of robotic training strategies are highly inconclusive. A possible explanation is that most current robotic systems cover only one neurorehabilitation strategy (e.g. reducing or augmenting movement errors) and may thus insufficiently address the subjects' individual needs and the characteristics of the task to be learned. In this study, Investigators will perform several motor learning experiments with healthy adult and neurological patients in order to evaluate the relative motor and cognitive benefits of newly developed robotic training strategies that modulate errors based on the subject's age, skill level and tasks characteristics. The effects of the new strategies will be compared to classical robotic assistance, and to non-robotic feedback approaches, such as visual feedback. The culmination of this work may help to optimize training benefits of already existing rehabilitation robots.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic motor training | Experimental | Behavioral: Robotic motor trainingParticipants will perform motor tasks (i.e. movements) with upper limb robotic devices applying different strategies (e.g. supporting or challenging the subject, or being fully compliant). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Informed Consent as documented by signature ("Informed Consent" form)
- Bodyweight <120 kg
- Ability to communicate effectively with the examiner so that the validity of the patient's data could not be compromised
Key exclusion criteria (8 listed)
- Excessive spasticity of the affected arm (Ashworth Scale ≥3)
- Serious medical or psychiatric disorder
- Orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
- Shoulder subluxation
- Skin ulcerations at the paretic 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 |
|---|---|---|
| Robotic motor trainingThe experiments consist in performing motor tasks with upper-limb robotic devices. | Behavioural | Robotic motor training |
Primary outcome
Change in kinematic performance assessed by the robot
Time frame: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Motion changes from baseline in the kinematic variables assessed by the robot and motion trackers during the motor learning task. The kinematic performance analysis consists of end-effector position in the x, y, and z-axis, in meters, and joint angles in degrees.
Change in kinetic performance assessed by the robot
Time frame: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Force changes from baseline in the kinetic variables assessed by the robot using force sensors during the motor learning task. Kinetic performance analysis consists of interaction forces in x, y, and z-axis, in N and applied robot joint torques by the motors, in Nm.
Spatial analysis of changes in evoked potentials as assessed by Electroencephalography (EEG) measurement
Time frame: Baseline, training (immediately after baseline), retention (1-2 days after the training)
Electroencephalographical assessment of changes in evoked potentials i.e. the electrical activity of the brain in response to stimulation of specific sensory nerve pathways.
5 secondary outcomes
Change in embodiment
Time frame: Before Intervention, Immediately after the end of intervention
Spatial analysis of changes in Task-Based Brain Connectivity as assessed by Electroencephalography (EEG) measurement
Time frame: Baseline, training (immediately after baseline or 1-2 days after baseline), retention (1-2 days after the training)
Change in Motivation as assessed by Intrinsic Motivation Inventory (IMI)
Time frame: Before Intervention, Immediately after the end of intervention, at the end of the session
Change in Cognitive Load as assessed by National Aeronautics and Space Administration (NASA) (Raw) Task Load Index
Time frame: Immediately after the end of intervention, At the end of the session
System Usability as assessed by System Usability Scale (SUS)
Time frame: Immediately after the end of intervention, At the end of the session
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 4 Sep 2025.
- Derived from this study: PubMed 35152897Ozen O, Buetler KA, Marchal-Crespo L. Towards functional robotic training: motor learning of dynamic tasks is enhanced by haptic rendering but hampered by arm weight support. J Neuroeng Rehabil. 2022 Feb 13;19(1):19. doi: 10.1186/s12984-022-00993-w.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication
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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.
Laura Marchal-Crespo, Prof. Dr. principal investigator
University of Bern, ARTORG Center for Biomedical Engineering Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic motor training in people with Stroke and Neurologic Disorder, run by University of Bern 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 4 inclusion and 8 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 4 Sep 2025. 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?
Change in kinematic performance assessed by the robot (time frame: Baseline, training (immediately after baseline), retention (1-2 days after the training)). The study lists 3 primary outcomes in all. 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 NCT04759976, which also lists 1 linked publication.
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 4 Sep 2025.