StrokeNCT06870682
Potential Effects of Novel Sensorimotor Upper Limb Rehabilitation Paradigm
A study testing ROBUST in people with Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal intervention combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ROBUST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Feb 2025to 2 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures
- A first-ever unilateral, supra-tentorial stroke, as defined by WHO (rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than vascular origin)
- ≥18 years old
- Being in the chronic phase after stroke, i.e. > 6 months post stroke
- Motor impairment in the upper limb, defined as Fugl-Meyer score >22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring <23 out of 66 will not be able to comply with the KINARM protocol)
- Residual sensory upper limb impairment, defined as Tactile Discrimination Test score <24 out of 25
- Impaired functionality, defined as Action Research Arm Test score <52 out of 57
- Manageable spasticity for KINARM tasks
Who cannot join
- Having musculoskeletal and/or other neurological disorders impacting care or prognosis
- Having severe communication or cognitive deficits that interfere with the protocol
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP
- Contraindications for robot-based therapy (e.g., uncontrolled epilepsy)
- Participation in another clinical investigation
- Having uncontrolled head movements (e.g. tremor), only relevant if participant is willing to receive the additional fNIRS assessments
Show all 18Show fewer
- Having any contra-indications for MRI, only relevant if participant is willing to receive the additional MRI assessments:
- Pacemaker
- Implantable Cardioverter Defibrillator (ICD)
- Cochlear implant
- Internal Insulin-pump
- Deep brain stimulation
- Any other metal device in body
- Claustrophobia
- Having a history of a neuropsychiatric or neurologic disorder before the diagnosis of stroke (e.g., depression, traumatic brain injury)
- Use of psychoactive medication before the diagnosis of stroke (e.g., anti-depressive medication)
- Use (or history of use) of drugs/alcohol
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Potential Effects of a Robot-based Upper Limb Rehabilitation Paradigm in Different Subgroups After Stroke: a Pilot Study
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal intervention combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study by recruiting 10 persons with chronic stroke. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Read the detailed description
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal therapy combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study. This intervention study will recruit 10 persons with chronic stroke. The participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. The participants will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, the participants receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, the participants follow 6 times a week a 1-hour home program. After this intervention period, the particpants are measured a last time using the same outcome measures as during the previous measuring moments. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Optionally, if the participants is willing and able to, additional MRI and/or fNIRS assessments will be added to give a first idea regarding changes in brain structure, function and activity because of this novel therapy approach. This study will inform the investigators to finalize the protocol for a following RCT.
- Conditions
- Stroke
- Being tested
- ROBUST
- Keywords
- Stroke, Upper limb, Sensorimotor, Sensory processing, Robot-based therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROBUSTBehavioural
During a 4-week intervention, participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 times a week a 1-hour home program. This intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing. It combines robot-based therapy, a transfer package to daily activities, and a home program.
| Study group | Role | What they receive |
|---|---|---|
| ROBUST intervention | Experimental | The participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 times a week a 1-hour home program. After this intervention period, they are measured a last time using the same outcome measures as during the previous measuring moments. Receives: Behavioral: ROBUST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test
Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance
Measured: From first measuring moment to last measuring moment after 8 weeks.
Secondary outcomes (9)
Sensorimotor Action Research Arm Test
Clinical assessment of sensorimotor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance
Measured: From first measuring moment to last measuring moment after 8 weeks.
Fugl-Meyer upper extremity assessment
Clinical assessment of motor function on an ordinal scale ranging from 0 to 66, with higher scores meaning better performance
Measured: From first measuring moment to last measuring moment after 8 weeks.
Tactile discrimination test
Clinical assessment of sensory processing with an area under the curve based scoring system, with higher scores meaning better performance
Measured: From first measuring moment to last measuring moment after 8 weeks.
Stroke Impact Scale
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. A higher score indicates less disability and better quality of life.
Measured: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Visually guided reaching task
Assessment of motor function using a 4-target centre-out reaching task on the Kinarm End-Point Lab
Measured: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Arm position matching task
Assessment of limb position sense using a 9-target mirror-matching task on the Kinarm End-Point Lab
Measured: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Passive and active discrimination task
Task on the Kinarm End-Point Lab used to assess passive and active sensory processing
Measured: From first measuring moment to last measuring moment after 8 weeks.
Optionally: MRI assessment
MRI scan to study the structure and function of the brain.
Measured: From first measuring moment to last measuring moment after 8 weeks.
Optionally: fNIRS assessment
The patient will be fitted with the fNIRS head cap during a standardized task on the Kinarm robot. This fNIRS measure studies brain activity during a sensorimotor activity.
Measured: From first measuring moment to last measuring moment after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start18 Feb 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
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.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Geert Verheyden, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870682
- Sponsor's protocol ID
- S69003
- Other IDs
- C2M/23/060
- Status last verified
- Mar 2026
- First submitted
- 6 Mar 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Heremans C, Martins IA, Yang S, Gooijers J, Orban de Xivry JJ, Verheyden G. Feasibility of ROBUST: An Integrated Sensorimotor Upper Limb Therapy for People in the Chronic Phase After Stroke. Brain Sci. 2026 Aug 8;16(8):844. doi: 10.3390/brainsci16080844.
PubMed 42651154
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Effects of a Robot-based Upper Limb Rehabilitation Paradigm in Different Subgroups After Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT06870682
- Acronym / sponsor ID
- S69003
- Conditions
- Stroke
- Keywords
- Stroke, Upper limb, Sensorimotor, Sensory processing, Robot-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 11 Mar 2025 (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.
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal intervention combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study by recruiting 10 persons with chronic stroke. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Detailed description
Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal therapy combining both motor and sensory function, with focus on sensory processing (one of the most important sensory functions), does not exists. However, the research team has developed a novel therapy paradigm combining robot-based training, a transfer package to daily life activities, and a home program. As a first step, the investigators will examine the feasibility and potential benefits of this novel therapy approach within this pilot study. This intervention study will recruit 10 persons with chronic stroke. The participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. The participants will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, the participants receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, the participants follow 6 times a week a 1-hour home program. After this intervention period, the particpants are measured a last time using the same outcome measures as during the previous measuring moments. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke.
Optionally, if the participants is willing and able to, additional MRI and/or fNIRS assessments will be added to give a first idea regarding changes in brain structure, function and activity because of this novel therapy approach. This study will inform the investigators to finalize the protocol for a following RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROBUST intervention | Experimental | Behavioral: ROBUSTThe participants will be measured a first time with both robot-based and clinical assessments. Thereafter, the participant follows a 4-week control period, only receiving standard care. After the control period, a second measuring moment is planned using the same outcome measures as during the first measurement. Then, a the 4-week intervention is planned, whereby participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 times a week a 1-hour home program. After this intervention period, they are measured a last time using the same outcome measures as during the previous measuring moments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent must be obtained prior to any screening procedures
- A first-ever unilateral, supra-tentorial stroke, as defined by WHO (rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than vascular origin)
- ≥18 years old
- Being in the chronic phase after stroke, i.e. > 6 months post stroke
- Motor impairment in the upper limb, defined as Fugl-Meyer score >22 out of 66 to demonstrate moderate to full upper limb motor function (patients scoring <23 out of 66 will not be able to comply with the KINARM protocol)
Key exclusion criteria (18 listed)
- Having musculoskeletal and/or other neurological disorders impacting care or prognosis
- Having severe communication or cognitive deficits that interfere with the protocol
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP
- Contraindications for robot-based therapy (e.g., uncontrolled epilepsy)
- Participation in another clinical investigation
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 |
|---|---|---|
| ROBUSTDuring a 4-week intervention, participants get 48 hours additional sensorimotor upper limb training. They will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, they follow 6 times a week a 1-hour home program. This intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing. It combines robot-based therapy, a transfer package to daily activities, and a home program. | Behavioural | ROBUST intervention |
Primary outcome
Action Research Arm Test
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance
9 secondary outcomes
Sensorimotor Action Research Arm Test
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Fugl-Meyer upper extremity assessment
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Tactile discrimination test
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Stroke Impact Scale
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Visually guided reaching task
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Arm position matching task
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Kinarm: Passive and active discrimination task
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Optionally: MRI assessment
Time frame: From first measuring moment to last measuring moment after 8 weeks.
Optionally: fNIRS assessment
Time frame: From first measuring moment to last measuring moment after 8 weeks.
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 19 Mar 2026.
- Derived from this study: PubMed 42651154Heremans C, Martins IA, Yang S, Gooijers J, Orban de Xivry JJ, Verheyden G. Feasibility of ROBUST: An Integrated Sensorimotor Upper Limb Therapy for People in the Chronic Phase After Stroke. Brain Sci. 2026 Aug 8;16(8):844. doi: 10.3390/brainsci16080844.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ROBUST in people with Stroke, run by KU Leuven at 1 site in Belgium.
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 8 inclusion and 18 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 19 Mar 2026. 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 Belgium. 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?
Action Research Arm Test (time frame: From first measuring moment to last measuring moment after 8 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 NCT06870682, 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 19 Mar 2026.