I63 I61 I67.6 I62 I60 S06.4 S06.5
Conditions
Interventions
Group 1: The intervention encompasses the use of wearables including a smart watch, continuous blood glucose measurement (CGM) and a mobile application on a mobile phone (in addition to usual care) du
Sponsors
Charité- Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Cerebrovascular disease including: ischemic stroke, venous infarction and intracranial hemorrhage (intracerebral, subarachnoid, subdural, epidural bleeding), confirmed with computer tomography (CT) or Magnetic Resonance Imaging (MRI) or clinical diagnosis by a neurologist. In-patient neurorehabilitation with a duration of at least 14 days. Informed consent provided by the patient.
Exclusion criteria
Exclusion criteria: 1. Medical conditions impeding the use of wearables including visual impairment and cognitive deficits. 2. Modified Rankin Scale at enrollment =5 3. Participation in another clinical trial with an investigational medicinal product or medical device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in patient engagement assessed using the Patient Activity Measure (PAM-13) at Visit 2 (End of the first intervention period) compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient motivation measured with PAREMO post intervention (V2, after the first intervention period, and V5, after the second intervention period) 2. Change in patient engagement after intervention in the outpatient setting (V5) 3. Feasibility of conducting the study intervention in a population of stroke rehabilitation patients in the in-patient and out-patient setting 4. Medical complications such as falls, recurrent vascular events, infections and mood disorders 5. Improvement in neurological function and dependency at time points V2 (after the first intervention period), V4 (before the second intervention period) and V6 (six months after study enrollment) 6. The subjective quality of life at time points V2 (after the first intervention period), V4 (before the second intervention period) and V6 (six months after study enrollment) 7. The association between glycemic variability derived from continuous blood glucose monitoring and cardiovascular events. 8. The validity of performing functional analyses via IMU 9. The change in clinical-neurological scores in the intervention group between pre and post intervention | — |
Countries
Germany
Contacts
Public ContactAlexander Nave
Charité- Universitätsmedizin Berlin, Klinik für Neurologie
Outcome results
None listed