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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
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.
Clinica Hildebrand Centro di riabilitazione Brissago
Brissago, Canton Ticino, Switzerland
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)
Time frame: Change from Baseline in motor impairment of the upper limb at 4 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline in neglect at 4 weeks
Neglect
Neglect is assessed with the Albert's test of neglect
Time frame: Change from Baseline in neglect at 8 weeks
Neglect
Neglect is assessed with the Albert's test of neglect
Time frame: Change from Baseline in neglect at 6 months
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Time frame: Change from Baseline in cognitive impairment at 4 weeks
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Time frame: Change from Baseline in cognitive impairment at 8 weeks
Cognitive impairment
Cognitive impairment is assessed with the Mini Mental State Examination
Time frame: Change from Baseline in cognitive impairment at 6 months
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Time frame: Change from Baseline in frontal lobe function at 4 weeks
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Time frame: Change from Baseline in frontal lobe function at 8 weeks
Frontal lobe function
Frontal lobe function is assessed with the Frontal assessment battery
Time frame: Change from Baseline in frontal lobe function at 6 months
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Time frame: Change from Baseline in aphasia at 4 weeks
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Time frame: Change from Baseline in aphasia at 8 weeks
Aphasia
Aphasia is assessed with the Aachener Aphasia Test
Time frame: Change from Baseline in aphasia at 6 months
Attention
Attention is assessed with the test to identify attention
Time frame: Change from Baseline in attention at 4 weeks
Attention
Attention is assessed with the test to identify attention
Time frame: Change from Baseline in attention at 8 weeks
Attention
Attention is assessed with the test to identify attention
Time frame: Change from Baseline in attention at 6 months
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