Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Study Overview
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Brief Summary
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The aim of this project is to clinically evaluate a novel robot-assisted therapeutic approach to train sensorimotor hand function after stroke. It combines the profound experience of the clinic Hildebrand in neurocognitive therapy - involving brain and mind in the task and training both the motor and the sensory system - with the advanced haptic robotic technology of the Rehabilitation Engineering Lab at the Swiss Federal Institute of Technology Zurich (ETH Zurich), allowing unmet interaction with the hand through the simulation of virtual objects with various mechanical properties. In a randomized controlled clinical trial, 10 sub-acute stroke patients will receive four weeks of robotic therapy sessions, integrated seamlessly into their daily rehabilitation program, while 10 other patients will receive conventional therapy. The investigators will assess baseline performance in an initial clinical and robotic assessment, with another assessment at the end of the four-week period, and in follow-ups four weeks and six months later. The contents of the patient-tailored robotic therapy sessions will match those of the conventional therapy as closely as possible. This study will demonstrate the feasibility of including robotic therapy of hand function into the daily rehabilitation program, and investigate the acceptance from patients and therapists. The investigators expect increased training intensity during the robotic therapy session compared to conventional sessions with similar contents, as well as novel insights into the recovery process of both the motor and the sensory system during the four weeks of therapy, through advanced robotic assessments integrated into the training sessions. This project is a first step towards making such robotic therapy available to patients as integration into the conventional individual therapy program (e.g. for self-training), and towards transferring this technology to the home environment.

Official Title
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Neurocognitive Robot-assisted Rehabilitation of Hand Function After Stroke

Conditions
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Stroke, Upper Extremity Paresis

Intervention / Treatment
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* Device: robot-assisted neurocognitive therapy of hand function
* Other: Conventional neurocognitive rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18-90 years old hemisyndrome (central paralysis of the upper extremity, and all degrees of weakness: M0 - M5 on the paresis scale) as a result of a first stroke sub-acute lesion not more than 6 weeks post ictus Exclusion Criteria: insufficient state of consciousness severe aphasia severe cognitive deficits severe pathologies of the upper extremity of traumatic or rheumatic nature severe pain in the affected arm Patients with pacemakers and other active implants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot group<br>Receive robot-assisted neurocognitive therapy instead of conventional neurocognitive therapy. (4 x 45 min/week) | Device: robot-assisted neurocognitive therapy of hand function<br>* 2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.<br>* Other names: Rehabilitation robot ReHapticKnob;|
| Active Comparator: Control group<br>Receive dose-matched conventional neurocognitive therapy | Other: Conventional neurocognitive rehabilitation<br>* Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.<br>* Other names: Perfetti-concept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor impairment of the upper limb | Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points) | Change from Baseline in motor impairment of the upper limb at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor impairment of the upper limb | Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points) | Change from Baseline in motor impairment of the upper limb at 8 weeks | 
| Motor impairment of the upper limb | Motor impairment of the upper limb is measured by the means of the Fugl-Meyer Assessment Scale of the upper limb (total of 66 points) | Change from Baseline in motor impairment of the upper limb at 6 months | 
| Functional improvement in dexterity | Functional improvement in dexterity is assessed with the Box and Block Test | Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks | 
| Functional improvement in dexterity | Functional improvement in dexterity is assessed with the Box and Block Test | Change from Baseline in functional improvement of dexterity of the upper limb at 8 weeks | 
| Functional improvement in dexterity | Functional improvement in dexterity is assessed with the Box and Block Test | Change from Baseline in functional improvement of dexterity of the upper limb at 6 months | 
| Spasticity level of the upper limb | Spasticity level is measured with the Modified Ashworth Scale | Change from Baseline in spasticity level of the upper limb at 4 weeks | 
| Spasticity level of the upper limb | Spasticity level is measured with the Modified Ashworth Scale | Change from Baseline in spasticity level of the upper limb at 8 weeks | 
| Spasticity level of the upper limb | Spasticity level is measured with the Modified Ashworth Scale | Change from Baseline in spasticity level of the upper limb at 6 months | 
| Tactile and proprioceptive sensory function of the upper limb | Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment | Change from Baseline in Tactile and proprioceptive sensory function of the upper limb at 4 weeks | 
| Tactile and proprioceptive sensory function of the upper limb | Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment | Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 8 weeks | 
| Tactile and proprioceptive sensory function of the upper limb | Tactile and proprioceptive sensory function of the upper limb is assessed with the Erasmus MC Nottingham Sensory Assessment | Change from Baseline in tactile and proprioceptive sensory function of the upper limb at 6 months | 
| Neglect | Neglect is assessed with the Albert's test of neglect | Change from Baseline in neglect at 4 weeks | 
| Neglect | Neglect is assessed with the Albert's test of neglect | Change from Baseline in neglect at 8 weeks | 
| Neglect | Neglect is assessed with the Albert's test of neglect | Change from Baseline in neglect at 6 months | 
| Cognitive impairment | Cognitive impairment is assessed with the Mini Mental State Examination | Change from Baseline in cognitive impairment at 4 weeks | 
| Cognitive impairment | Cognitive impairment is assessed with the Mini Mental State Examination | Change from Baseline in cognitive impairment at 8 weeks | 
| Cognitive impairment | Cognitive impairment is assessed with the Mini Mental State Examination | Change from Baseline in cognitive impairment at 6 months | 
| Frontal lobe function | Frontal lobe function is assessed with the Frontal assessment battery | Change from Baseline in frontal lobe function at 4 weeks | 
| Frontal lobe function | Frontal lobe function is assessed with the Frontal assessment battery | Change from Baseline in frontal lobe function at 8 weeks | 
| Frontal lobe function | Frontal lobe function is assessed with the Frontal assessment battery | Change from Baseline in frontal lobe function at 6 months | 
| Aphasia | Aphasia is assessed with the Aachener Aphasia Test | Change from Baseline in aphasia at 4 weeks | 
| Aphasia | Aphasia is assessed with the Aachener Aphasia Test | Change from Baseline in aphasia at 8 weeks | 
| Aphasia | Aphasia is assessed with the Aachener Aphasia Test | Change from Baseline in aphasia at 6 months | 
| Attention | Attention is assessed with the test to identify attention | Change from Baseline in attention at 4 weeks | 
| Attention | Attention is assessed with the test to identify attention | Change from Baseline in attention at 8 weeks | 
| Attention | Attention is assessed with the test to identify attention | Change from Baseline in attention at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hand function, fine motor skills, neurocognitive, sensory, Perfetti, haptics, stroke, acute, rehabilitation, robot therapy