Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke: a Randomized Controlled Trial

NCT07547800 | Not Yet Recruiting DMC

• 1 other identifier: S71234
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief 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. 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, we developed an intensive sensorimotor robot-based rehabilitation paradigm (called ROBUST) with focus on sensory processing. As a first step, we 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, we finalized the protocol for this RCT to investigate the effectiveness of the ROBUST intervention.

Conditions

Stroke; Healthy Adult

Keywords

Stroke; Upper limb; Sensorimotor; Sensory processing; Robot-based therapy; MRI; fNIRS; Clinical outcomes; Kinematic outcomes

Outcome Measures

Primary Outcomes (1)

• 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 after 9-18 weeks (depending on group allocation).

Secondary Outcomes (10)

• Sensorimotor Action Research Arm Test

  From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).

• Fugl-Meyer Assessment for the upper extremity

  From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).

• Tactile Discrimination Test

  From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).

• Stroke Impact Scale

  From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).

• Motor Activity Log

  From first measuring moment to last measuring moment after 9-18 weeks (depending on group allocation).

Other Outcomes (3)

• Oxford Cognitive Screen

  Only during the first measuring moment.

• Motivation for Rehabilitation Scale

  Between the first measuring moment until the second/fourth measuring moment after 5-14 weeks (depending on group allocation).

• Patient Experience Questionnaire

  Only during the last therapy session of the ROBUST intervention in the stroke experimental group (after 5 weeks).

Study Arms (3)

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).

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).

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).

Behavioral: Kinarm therapy

Interventions

ROBUST BEHAVIORAL

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.

Stroke experimental group

Kinarm therapy BEHAVIORAL

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.

Healthy control group; Stroke control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven, Gebouw De Nayer

Leuven, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Charlotte Heremans

CONTACT

+32 0483 746 007; robust@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: In this study, we 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.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

BE (1)