Potential Effects of Novel Sensorimotor Upper Limb Rehabilitation Paradigm

NCT06870682 | Completed

• 2 other identifiers: S69003C2M/23/060
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke

Keywords

Stroke; Upper limb; Sensorimotor; Sensory processing; Robot-based therapy

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 8 weeks.

Secondary Outcomes (9)

• Sensorimotor Action Research Arm Test

  From first measuring moment to last measuring moment after 8 weeks.

• Fugl-Meyer upper extremity assessment

  From first measuring moment to last measuring moment after 8 weeks.

• Tactile discrimination test

  From first measuring moment to last measuring moment after 8 weeks.

• Stroke Impact Scale

  From first measuring moment to last measuring moment after 8 weeks.

• Kinarm: Visually guided reaching task

  From first measuring moment to last measuring moment after 8 weeks.

Study Arms (1)

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.

Behavioral: ROBUST

Interventions

ROBUST BEHAVIORAL

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.

ROBUST intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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

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
• 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
• 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)

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

KU Leuven

Leuven, 3001, Belgium

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: February 18, 2025
• Primary Completion: October 2, 2025
• Study Completion: October 2, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

BE (1)