Stroke
Conditions
Keywords
automatic, personalized, robotic therapy
Brief summary
The primary goal of this project is to test the safeness and clinical effectiveness of a novel exoskeleton for the upper limb (Arm Light Exoskeleton Rehab Station, ALEx RS) developed at Wearable Robotics srl, for the force assistance of stroke patients during robotic-rehabilitation. The secondary study aim is to design and test an automatic personalized robot-based upper limb motor rehabilitation protocol targeting the specific kinematic performance of each patient. Finally, the study also aims to define the neuro-biomechanical state of the patient and its evolution during the therapy by studying cortical signals and muscular synergies. This information will be used to improve the personalization of the robotic treatment by targeting not only the motor performance but also the cerebral and muscular activity of the patient. The study is longitudinally designed in order to test the safeness and clinical effectiveness of ALEx RS over time, and to monitor the clinical effectiveness of the automatic personalized robotic therapy from the beginning until the end of the treatment. Moreover, in order to estimate the long-term clinical effectiveness of the treatment, the assessment methods proposed in the clinical trial will be repeated one month after the end of the treatment.
Interventions
DEVICEArm Light Exoskeleton Rehab Station (ALEx RS)
ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress.
DEVICEArm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized
ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress. The movements to be performed by the patient are automatically decided by the exoskeleton.
Sponsors
University Hospital, Geneva
Azienda Ospedaliero, Universitaria Pisana
Ecole Polytechnique Fédérale de Lausanne
Wearable Robotics srl.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* stroke patients * right and left hand dominant * cerebral lesion onset between 2-8 weeks * able to participate in a session of about 30-60 minutes * right-hemiplegic with at least 10° of motion in the treated joints (shoulder and elbow) * age: more than 18 years old
Exclusion criteria
* subjects with an active implantable device or wearing an active device (e.g., pacemakers, metallic objects in the brain, infusion pumps, etc.) * persistent delirium or disturbed vigilance * moderate or severe language comprehension deficits * skull breach * new stroke lesions during rehabilitation * patients incapable of discernment * subjects with reduced mobility due to previous injuries or abnormalities unrelated with the cerebral accident
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluated through the number of adverse events | 2 years |
| Efficacy evaluated through Fugl-Meyer | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of personalized therapy evaluated through Fugl-Meyer | 2 years | The secondary outcome of the study is the evaluation of the differences on the outcome for a personalized vs a standard robotic rehabilitation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Neurobiomechanical state evaluated through kinematics | 2 years | Definition of the neurobiomechanical state of the patient and its evolution during the therapy |
| Neurobiomechanical state evaluated through brain activity measured with functional Magnetic Resonance Imaging (fMRI) | 2 years | Definition of the neurobiomechanical state of the patient and its evolution during the therapy |
| Neurobiomechanical state evaluated through muscle activity measured with electromyography (EMG) | 2 years | Definition of the neurobiomechanical state of the patient and its evolution during the therapy |
| Neurobiomechanical state evaluated through brain activity measured with electroencephalography (EEG) | 2 years | Definition of the neurobiomechanical state of the patient and its evolution during the therapy |
Countries
Switzerland
Outcome results
None listed