Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke (RCT ROBUST)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Healthy Adult
• Intervention / Treatment: Behavioral: ROBUST; Behavioral: Kinarm therapy

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 Type: Interventional
• Enrollment (Estimated): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charlotte Heremans; Phone Number: +32 0483 746 007; Email: robust@kuleuven.be

Study Locations

• Belgium
  • Leuven, Belgium
    • KU Leuven, Gebouw De Nayer
    • Contact: Geert Verheyden, Prof. Dr.; Phone Number: +32 16 32 91 16; Email: geert.verheyden@kuleuven.be
    • Principal Investigator: Geert Verheyden, Prof. Dr.
    • Sub-Investigator: Jolien Gooijers, Prof. Dr.
    • Sub-Investigator: Jean-Jacques Orban de Xivry, Prof. Dr.
    • Sub-Investigator: Charlotte Heremans
    • Sub-Investigator: Inês Martins
    • Sub-Investigator: Siqi Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke experimental group; 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).	Behavioral: ROBUST; 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.
Other: Stroke control group; 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).	Behavioral: Kinarm therapy; 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.
Other: Healthy control group; 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).	Behavioral: Kinarm therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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	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.	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.	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.	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.	From first measuring moment to last measuring moment (9-18 weeks, depending on group allocation).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxford Cognitive Screen	A domain-specific cognitive screening tool. The domains assessed are Language, Praxis, Number, Memory, Spatial and Controlled Attention. The following tasks are included: Picture Naming (range: 0-4), Semantics (range: 0-3), Orientation (range: 0-4), Visual Field (range: 0-4), Sentence Reading (range: 0-15), Number Writing (range: 0-3), Calculation (range: 0-4), Broken Hearts Test (range: 0-50), Imitation (range: 0-12), Verbal Recall & Recognition (range: 0-4), Episodic recognition (range: 0-4) and Executive task (perfect outcome = -1). Higher scores mean better cognitive performance, except for the Executive task.	Only during the first measuring moment.
Motivation for Rehabilitation Scale	A questionnaire investigating the motivation of the patient for following rehabilitation ranging from 0 to 119 points. A higher score means a higher motivation.	Between the first measuring moment until the second/fourth measuring moment (5-14 weeks, depending on group allocation).
Patient Experience Questionnaire	A study-specific questionnaire to gather feedback regarding the ROBUST intervention. Included questions where multiple-choice questions, questions ranging from fully agree to fully disagree, and open questions.	Only during the last therapy session of the ROBUST intervention in the stroke experimental group (5 weeks).

Collaborators and Investigators

• Sponsor: KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): April 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MRI; Stroke; Upper limb; fNIRS; Sensory processing; Clinical outcomes; Robot-based therapy; Sensorimotor; Kinematic outcomes
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: S71234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No