Stroke patients with a severely paralysed arm I63
Conditions
Interventions
Group 1: The exoskeleton will mobilize the arm of the subjects performing different reaching and grasping tasks. The subject will controll the exoskeleton using EEG and EMG activity.
Group 2: The exo
Sponsors
Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Ischemic or hemorrhagic stroke with subcortical damage and, if possible, intact motor cortex. 2. Considerable motor impairment in the upper-limb, with MRC (Medical Research Council) below 2 out of 5 (0 = no movement; 1 = only a trace or flicker of movement is seen or felt, or muscle twitching/spasms (fasciculations) are observed; 2 = muscle can only move if resistance of gravity is removed; 3 = strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed; 4 = reduced strength, but contraction can still move joint against resistance; 5 = muscle contraction against full resistance, normal;). 3. Paralysis of one hand with no residual active finger extension 4. Time since stroke of at least 6 months (chronic stage) 5. Age 18 to 80. 6. No psychiatric or neurological condition other than stroke 7. No cerebellar lesion or bilateral motor deficit 8. No pregnancy 9. No claustrophobia 10. No epilepsy or medication for epilepsy during the last 6 months 11. Eligibility to undergo magnetic resonance imaging (MRI) 12. Ability to understand and follow instructions
Exclusion criteria
Exclusion criteria: 1. Drug and/or alcohol abuse 2. Psychiatric disorder (including post-stroke depression) 3. Cerebellar damage 4. Bilateral motor deficit 5. Uncontrolled health problems (coronary heart disease, severe heart failure in stage III-IV according to NYHA, severe cardiac arrhythmia, severe edema, severe arthritis, malignant tumor, chronic renal failure) 6. Cognitive impairment (Mini Mental State below 23/30 points). Patients with cognitive or language difficulties that will prevent them giving informed consent and/or follow instructions 7. Pregnancy 8. Drug-resistant epilepsy 9. Pacemakers, metallic implants (ferromagnetic) or claustrophobia, contraindications to undergo magnetic resonance imaging (MRI)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A physiotherapist will carry out the following measures on two different days before the intervention, immediately after intervention and six months after intervention completion: - Fugl-Meyer Assessment (FMA): a stroke-specific, performance-based impairment index. - Action Research Arm Test (ARAT): an evaluative measure to assess specific changes in limb function among individuals who have suffered a stroke. - Polysomnography (PSG): a multi-parametric test used in the study of sleep. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following data will be acquired and analyzed for clinical assessment before and after intervention: - Assessment of functional and structural changes in the brain due to intervention: functional and anatomical magnetic resonance imaging (fMRI and aMRI). - Assessment of Motor Evoked Potentials (MEPs): Transcraneal Magnetic Stimulation (TMS). - Functional stimulation amplitude needed to induce a muscle contraction (motor threshold) will be used to assess muscle fibers status The following data will be acquired and analyzed for clinical assessment before, during and after intervention: - Electromyography data will be acquired on both arms (healthy and paretic) to assess muscle function - Electroencephalography data to assess brain activity changes - Kinematics data will be obtained via exoskeleton sensors to assess motor performance and range of motion | — |
Countries
Germany
Contacts
Public ContactAnder Ramos-Murguialday
Institute of Medical Psychology and Behavioral Neurobiology. University of Tübingen
Outcome results
None listed