Paresis in upper-limb due to ischemic or hemorrhagic stroke I61 I63 I64
Conditions
Interventions
Group 1: Three 1-hour wrist motion training sessions (three separate days) with a target tracking task: with FES Assistance (and sham Robot)
Group 2: Three 1-hour wrist motion training sessions (three
Sponsors
Schön Klinik Bad Aibling
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subacute and chronic patient after stroke in an inpatient rehabilitation centre, Ischemic or hemorrhagic infarction, Age >= 18 years, Cognitively able to follow instructions, Low level or no pain in wrist or fingers at rest (NRS < 4), Functional impairments in wrist or fingers (MRC <=3), Able to sit in a chair with the wrist position in the robotic device for the duration of the session (session < 2 hours), Familiar with electrical stimulation, Able to understand and accept their participation in one of the studies.
Exclusion criteria
Exclusion criteria: robot-related exclusion criteria: High level of pain in the wrist or hand resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend the user’s wrist more than 20 degrees while in the robot Severe contractures or muscle tone resulting in the operator’s inability to position the user’s arm and hand in the HRX-1 device and flex or extend or rotate the user’s wrist more than 20 degrees while in the robot Severe psychiatric disorder FES-related exclusion criteria: Pregnancy People with active implantable devices (e.g., pacemakers) or other metal implants within the area stimulated by the FES device No motion or muscle contraction resulting from FES (atrophy) Patients suffering from peripheral nerve damage (e.g., polyneuropathy) Patients with severe epilepsy or frequent epileptic seizures in the past Cancer or wounds in the FES application area Other exclusion criteria: Patient has no function AND no deep sensitivity in the fingers or wrist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kinematics (i.e., wrist motion): measured from sensors in robotic device. Outcome will be measured during all training sessions. Kinetics (i.e., torque): measured from sensors in robotic device. Outcome will be measured during all training sessions. Neurophysiological signals (i.e., EMG and/or EEG): measured from sensors placed on the skin. EMG signals will be obtained during all training sessions and EEG signals will be obtained for some participants during all training sessions. Subjective outcomes about interaction experience: measured from patient-reported questionnaires. Outcomes will be obtained during and after all training sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious gaming scores of the tracking task: calculated by the software by using metrics such as the distance between the target position and the subject's position. Outcome will be obtained during all training sessions. | — |
Countries
Germany
Contacts
Public ContactCarmen Krewer
Schoen Klinik Bad Aibling
Outcome results
None listed