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Robot therapy aims to restore arm movement after stroke

NCT ID NCT07547800

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new robot-based therapy designed to improve arm movement and sensation in people who had a stroke more than six months ago. The therapy focuses on helping the brain better process sensory information from the arm. The trial will include 109 participants and compare the robot therapy to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 109 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria stroke participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. 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); 3. ≥18 and ≤85 years old; 4. Being a Dutch speaker; 5. Being in the chronic phase after stroke, i.e. \> 6 months post stroke; 6. 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); 7. Residual sensory upper limb impairment, defined as Tactile Discrimination Test (Area Under Curve) \<73.10%; 8. Impaired functionality, defined as sensorimotor Action Research Arm Test score \<52 out of 57; 9. Manageable spasticity for Kinarm tasks. Inclusion Criteria healthy participants: 1. Written informed consent must be obtained prior to any screening procedures; 2. ≥18 and ≤85 years old; 3. Being a Dutch or English speaker; 4. No history of stroke or transient ischemic attack; 5. No recent brain/head injury; 6. No major upper limb sensory or motor impairments. Exclusion Criteria: 1. Having musculoskeletal and/or other neurological disorders impacting care or prognosis; 2. Having severe communication or cognitive deficits that interfere with the protocol; 3. Having severe spasticity (cannot handle Kinarm robot); 4. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP; 5. Contraindications for robot-based therapy (e.g., uncontrolled epilepsy); 6. Participation in another clinical investigation; 7. 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 8. 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 9. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • KU Leuven, Gebouw De Nayer

    Leuven, Belgium

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Other studies related to the condition(s) this trial covers.