StrokeRCT ROBUSTNCT07547800
Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke
A study testing ROBUST and Kinarm therapy in people with Stroke and Healthy Adult, run by KU Leuven at 1 site in Belgium.
Trial summary
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Healthy Adult
- What is being tested?
- ROBUST and Kinarm therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- Healthy volunteers accepted
- 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 and ≤85 years old;
- Being a Dutch speaker;
- 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);
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- Residual sensory upper limb impairment, defined as Tactile Discrimination Test (Area Under Curve) <73.10%;
- Impaired functionality, defined as sensorimotor Action Research Arm Test score <52 out of 57;
- Manageable spasticity for Kinarm tasks.
- Written informed consent must be obtained prior to any screening procedures;
- ≥18 and ≤85 years old;
- Being a Dutch or English speaker;
- No history of stroke or transient ischemic attack;
- No recent brain/head injury;
- No major upper limb sensory or motor impairments.
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;
- Having severe spasticity (cannot handle Kinarm robot);
- 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;
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- Having any contraindications for fNIRS*：
- Uncontrolled head movements (e.g. tremor)
- Scalp lesion at optode sites (wound/incision/infection/hematoma)
- Decompressive craniectomy or large skull defect over target regions
- Persistent hair-optode coupling failure despite best practices, or non-removable obstructions preventing adequate coupling
- Having any contraindications for MRI**:
- Pacemaker
- Implantable Cardioverter Defibrillator (ICD)
- Cochlear implant
- Internal Insulin-pump
- Deep brain stimulation
- Any other metal device in the 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)
- Misuse (or history of misuse) of drugs/alcohol
- Currently undergoing a structured arm and/or hand training (e.g. engaging in playing a musical instrument)**.
- Stroke patients and healthy participants showing these exclusion criteria will be included in the RCT protocol, but will not be measured with fNIRS.
- Stroke patients showing these exclusion criteria will be included in the RCT protocol, but will not be measured with MRI. Healthy adults showing these exclusion criteria will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
KU Leuven, Gebouw De Nayer
Leuven
Geert Verheyden, Prof. Dr., +32 16 32 91 16, geert.verheyden@kuleuven.be
Geert Verheyden, Prof. Dr.
About this study
Official title: Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke: a Randomized Controlled Trial
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Read the detailed description
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT.
Within this RCT, the investigators will include participants with chronic stroke and healthy controls. The participants with stroke will be randomly divided in two groups: the experimental group and control group. The experimental group will receive an additional integrated treatment paradigm to their standard care. This novel integrated treatment (called ROBUST) is a combination of robot-based (Kinarm), conventional and home therapy. The control group will first receive their standard care alone, followed by an additional Kinarm therapy (one part of ROBUST) to their standard care. The healthy controls will also first receive no additional therapy, followed by the additional Kinarm therapy. After each control period (no extra therapy) and/or each intervention period (additional ROBUST or Kinarm therapy), a follow-up period is included whereby the participants just follow their standard care.
The aim is to investigate the effects of the additional ROBUST rehabilitation, compared to the standard care, and compared to the additional Kinarm therapy. The investigators will investigate the differences in sensorimotor improvement induced by the additional Kinarm therapy between persons with stroke and healthy controls. Finally, the investigators will investigate the clinical and kinematic effectiveness, as well as potential changes in brain function (activity and connectivity) and structure.
- Conditions
- Stroke, Healthy Adult
- Being tested
- ROBUST, Kinarm therapy
- Keywords
- Stroke, Upper limb, Sensorimotor, Sensory processing, Robot-based therapy, MRI, fNIRS, Clinical outcomes, Kinematic outcomes
- 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 5-week intervention, participants in the stroke experimental group get 48 hours additional sensorimotor upper limb training. They will come 2-3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy (Kinarm therapy) and one hour transfer package training with a therapist. Additionally, they follow 4-5 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.
Kinarm therapyBehavioural
During a 5-week intervention, participants in the stroke control group and the healthy control group get 12 hours additional Kinarm therapy (one part of the ROBUST intervention). They will come 2-3 times per week to Leuven for a one-hour therapy session. This robotic intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing.
| Study group | Role | What they receive |
|---|---|---|
| Stroke experimental group | Experimental | The stroke experimental group will receive a 48-hour ROBUST intervention (in addition to their standard care) spread over 5 weeks, followed by a 4-week follow-up period (only standard care). Receives: Behavioral: ROBUST |
| Stroke control group | Other | The stroke control group will first receive their standard care only over 5 weeks (no additional intervention), followed by a 4-week follow-up period (only standard care).
Thereafter, this group will receive a 12-hour Kinarm-therapy (one part of the ROBUST intervention, additional to their standard care) spread over 5 weeks, followed by another 4-week follow-up period (only standard care). Receives: Behavioral: Kinarm therapy |
| Healthy control group | Other | The healthy control group will first have a 4-week control period whereby they do not receive additional training, followed by a 12-hour Kinarm therapy (one part of the ROBUST intervention) spread over 5 weeks. Thereafter, they have a 4-week follow-up period (no extra training). Receives: Behavioral: Kinarm therapy |
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 (9-18 weeks, depending on group allocation).
Secondary outcomes (10)
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 (9-18 weeks, depending on group allocation).
Fugl-Meyer Assessment for the upper extremity
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 (9-18 weeks, depending on group allocation).
Tactile Discrimination Test
Clinical assessment of sensory processing with an area under the curve based scoring system ranging from 0-100%, with higher scores meaning better performance.
Measured: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Stroke Impact Scale
A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Each category ranges from 0-100. A higher score indicates less disability and better quality of life.
Measured: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Motor Activity Log
A semi-structured interview in which patients are asked how often (frequency) and how well (quality) they use the affected arm when performing upper extremity activities. Each category ranges from 0 to 5 points. A higher score indicates better frequency and quality.
Measured: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
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 (9-18 weeks, depending on group allocation).
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 (9-18 weeks, depending on group allocation).
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 (9-18 weeks, depending on group allocation).
MRI assessment
MRI scan to study the structure and function of the brain, during rest and during a sensorimotor upper limb task.
Measured: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
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 (9-18 weeks, depending on group allocation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, the investigators will include 58 chronic stroke participants and 51 healthy participants. The stroke participants will be randomized in a control group or experimental group. The outcome assessors are blinded for the stroke participants, but not for the healthy participants. The healthy participants will just be one control group, they will not be randomized.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (estimated)
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
- NCT07547800
- Sponsor's protocol ID
- S71234
- Acronym
- RCT ROBUST
- Status last verified
- May 2026
- First submitted
- 17 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07547800
- Acronym / sponsor ID
- RCT ROBUST / S71234
- Conditions
- Stroke, Healthy Adult
- Keywords
- Stroke, Upper limb, Sensorimotor, Sensory processing, Robot-based therapy, MRI, fNIRS, Clinical outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 109 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Apr 2026 (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 commonly impaired after stroke, even in the chronic phase (>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.
Detailed description
Sensorimotor function of the upper limb is commonly impaired after stroke, even in the chronic phase (>6 months post-stroke). Nevertheless, good sensorimotor function is needed for daily life functioning. Sensorimotor function can be divided into three components: exteroception, proprioception and sensory processing. It is important that those three components will each be addressed in the upper limb rehabilitation. Unfortunately, there is still no optimal therapy to address sensory processing. Therefore, the investigators developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, the investigators did a pilot study (S69003) including 10 persons with chronic stroke to investigate the potential effectiveness and feasibility of this novel rehabilitation. The median change score of motor, sensory and sensorimotor assessments was exceeding the minimal clinical important difference (MCID), and the total amount of therapy was feasible as well. The investigated protocols to measure potential changes in brain function (activity and connectivity) and structure accompanying the novel therapy appeared feasible as well. Based on this first pilot study, the investigators finalized the protocol for this RCT.
Within this RCT, the investigators will include participants with chronic stroke and healthy controls. The participants with stroke will be randomly divided in two groups: the experimental group and control group. The experimental group will receive an additional integrated treatment paradigm to their standard care. This novel integrated treatment (called ROBUST) is a combination of robot-based (Kinarm), conventional and home therapy. The control group will first receive their standard care alone, followed by an additional Kinarm therapy (one part of ROBUST) to their standard care. The healthy controls will also first receive no additional therapy, followed by the additional Kinarm therapy. After each control period (no extra therapy) and/or each intervention period (additional ROBUST or Kinarm therapy), a follow-up period is included whereby the participants just follow their standard care.
The aim is to investigate the effects of the additional ROBUST rehabilitation, compared to the standard care, and compared to the additional Kinarm therapy. The investigators will investigate the differences in sensorimotor improvement induced by the additional Kinarm therapy between persons with stroke and healthy controls. Finally, the investigators will investigate the clinical and kinematic effectiveness, as well as potential changes in brain function (activity and connectivity) and structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In this study, the investigators will include 58 chronic stroke participants and 51 healthy participants. The stroke participants will be randomized in a control group or experimental group. The outcome assessors are blinded for the stroke participants, but not for the healthy participants. The healthy participants will just be one control group, they will not be randomized.
| Arm | Type | Receives |
|---|---|---|
| Stroke experimental group | Experimental | Behavioral: ROBUSTThe stroke experimental group will receive a 48-hour ROBUST intervention (in addition to their standard care) spread over 5 weeks, followed by a 4-week follow-up period (only standard care). |
| Stroke control group | Other | Behavioral: Kinarm therapyThe stroke control group will first receive their standard care only over 5 weeks (no additional intervention), followed by a 4-week follow-up period (only standard care). Thereafter, this group will receive a 12-hour Kinarm-therapy (one part of the ROBUST intervention, additional to their standard care) spread over 5 weeks, followed by another 4-week follow-up period (only standard care). |
| Healthy control group | Other | Behavioral: Kinarm therapyThe healthy control group will first have a 4-week control period whereby they do not receive additional training, followed by a 12-hour Kinarm therapy (one part of the ROBUST intervention) spread over 5 weeks. Thereafter, they have a 4-week follow-up period (no extra training). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 and ≤85 years old;
- Being a Dutch speaker;
- Being in the chronic phase after stroke, i.e. > 6 months post stroke;
Key exclusion criteria (25 listed)
- Having musculoskeletal and/or other neurological disorders impacting care or prognosis;
- Having severe communication or cognitive deficits that interfere with the protocol;
- Having severe spasticity (cannot handle Kinarm robot);
- 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);
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 5-week intervention, participants in the stroke experimental group get 48 hours additional sensorimotor upper limb training. They will come 2-3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, they receive one hour robot-based therapy (Kinarm therapy) and one hour transfer package training with a therapist. Additionally, they follow 4-5 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 | Stroke experimental group |
| Kinarm therapyDuring a 5-week intervention, participants in the stroke control group and the healthy control group get 12 hours additional Kinarm therapy (one part of the ROBUST intervention). They will come 2-3 times per week to Leuven for a one-hour therapy session. This robotic intervention can be distinguished from others since it integrates both motor and sensory function, with focus on sensory processing. | Behavioural | Healthy control group, Stroke control group |
Primary outcome
Action Research Arm Test
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Clinical assessment of motor activity performance on an ordinal scale ranging from 0 to 57, with higher scores meaning better performance.
10 secondary outcomes
Sensorimotor Action Research Arm Test
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Fugl-Meyer Assessment for the upper extremity
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Tactile Discrimination Test
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Stroke Impact Scale
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Motor Activity Log
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Kinarm: Visually Guided Reaching Task
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Kinarm: Arm Position Matching Task
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Kinarm: Passive and Active Discrimination Task
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
MRI assessment
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
fNIRS assessment
Time frame: From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 and Kinarm therapy in people with Stroke and Healthy Adult, 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 15 inclusion and 25 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: opening soon, as of the sponsor's last update on 11 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Heremans (+32 0483 746 007, robust@kuleuven.be), or a site near the patient. 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 (9-18 weeks, depending on group allocation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2026.