Chronic stroke patients (Stroke onset more than 12 months ago)
Conditions
Interventions
Group 1: Intervention: Brain/Neural-controlled hand exoskeleton training of bimanual tasks for neurorehabilitation after stroke
Target population: Chronic stroke patients (Onset > 12 months)
Sponsors
Charité Universitätsmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Clinically confirmed ischemic or hemorrhagic stroke; Chronic stroke (>12 months post-stroke); Mild or severe residual motor impairment of upper limb; Ability to understand study procedures and provide informed consent
Exclusion criteria
Exclusion criteria: Contraindications for MRI or TMS; History of epilepsy or seizures; Severe cognitive impairment; Other neurological or psychiatric disorders that may interfere with study participation or outcome assessment; Additional intensive upper-limb rehabilitation during the study period or concurrent participation in other interventional studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WHAT: Voluntary muscle activity WHEN: Pre-Training (Baseline), then every Monday, Wednesday and Friday during training weeks, At the end of the study (Post-Training), 1 months after study completion (Follow-up), in total: 26 Data Points HOW: Measuring electromyography (EMG) via EMG-armband while patients perform 3 different hand gestures | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) DTI & MRT WHAT: Structural and functional brain connectivity WHEN: Pre-Training, Post-Training, 1 month after study completion (follow-up) HOW: Diffusion tensor imaging (DTI) and resting-state functional magnetic resonance imaging (rs-fMRI) 2) MEP WHAT: Corticospinal excitability WHEN: Pre-Training, Post-Training, 1 month after study completion (follow-up) HOW: Measurement of motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) 3) Fugl-Meyer & Ashworth WHAT: Motor impairment and spasticity WHEN: Weekly during all 8 training weeks and 1 month after study completion (follow-up) HOW: Clinical assessment using the Fugl-Meyer Assessment (FMA) and Modified Ashworth Scale (MAS) 5) BeBiT-S WHAT: Bimanual task performance in stroke survivors WHEN: Pre-Training, After 4 Training weeks (Halftime), Post-Training, 1 month after study completion (follow-up) HOW: Assessment using the Berlin bimanual test for stroke survivors (BeBiT-S) | — |
Countries
Germany
Contacts
Public ContactTeresa Höhn
Charité Universitätsmedizin Berlin
Outcome results
None listed