Stroke, Upper Extremity Paresis
Conditions
Keywords
stroke, acute, rehabilitation, robot therapy, hand function, fine motor skills, neurocognitive, sensory, Perfetti, haptics
Brief summary
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.
Interventions
DEVICErobot-assisted neurocognitive therapy of hand function
2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
OTHERConventional neurocognitive rehabilitation
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.
Sponsors
Roger Gassert
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor impairment of the upper limb | Change from Baseline in motor impairment of the upper limb at 4 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neglect | Change from Baseline in neglect at 4 weeks | Neglect is assessed with the Albert's test of neglect |
| Functional improvement in dexterity | Change from Baseline in functional improvement of dexterity of the upper limb at 4 weeks | Functional improvement in dexterity is assessed with the Box and Block Test |
| Spasticity level of the upper limb | Change from Baseline in spasticity level of the upper limb at 4 weeks | Spasticity level is measured with the Modified Ashworth Scale |
| Tactile and proprioceptive sensory function of the upper limb | 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 is assessed with the Erasmus MC (Medical Center) Nottingham Sensory Assessment |
| Motor impairment of the upper limb | Change from Baseline in motor impairment of the upper limb at 8 weeks | 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) |
| Frontal lobe function | Change from Baseline in frontal lobe function at 4 weeks | Frontal lobe function is assessed with the Frontal assessment battery |
| Aphasia | Change from Baseline in aphasia at 4 weeks | Aphasia is assessed with the Aachener Aphasia Test |
| Attention | Change from Baseline in attention at 4 weeks | Attention is assessed with the test to identify attention |
| Cognitive impairment | Change from Baseline in cognitive impairment at 4 weeks | Cognitive impairment is assessed with the Mini Mental State Examination |
Countries
Switzerland
Outcome results
None listed