Effects of a Robot-based Sensorimotor Upper Limb Rehabilitation Paradigm in Chronic Stroke

ConditionsStroke Healthy Adult

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-85

SponsorKU Leuven

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.

Treatment groups

109 Participants

are divided into 3 treatment groups

Group A: Stroke experimental groupExperimental treatment 1 intervention

Group B: Stroke control groupOther 1 intervention

Group C: Healthy control groupOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame