NCT06870682

Potential Effects of Novel Sensorimotor Upper Limb Rehabilitation Paradigm

Potential Effects of a Robot-based Upper Limb Rehabilitation Paradigm in Different Subgroups After Stroke: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Sensorimotor function of the upper limb is often impaired after stroke, even in the chronic phase (minimum 6 months after stroke). Currently, an optimal therapy 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. This intervention study will recruit 10 persons with chronic stroke. 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. The participants will come 3 times per week to Leuven for a therapy session of two hours. During these therapy sessions, the participants receive one hour robot-based therapy and one hour transfer package training with a therapist. Additionally, the participants follow 6 times a week a 1-hour home program. After this intervention period, the particpants are measured a last time using the same outcome measures as during the previous measuring moments. The investigators hypothesize that this therapy approach is feasible and potentially effective in chronic stroke. Optionally, if the participants is willing and able to, additional MRI and/or fNIRS assessments will be added to give a first idea regarding changes in brain structure, function and activity because of this novel therapy approach. This study will inform the investigators to finalize the protocol for a following RCT.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	ROBUST	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.

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2025-03-11
• Last updated: 2026-03-19

Locations

1 site across 1 country: Belgium