G81 G45 I60 I61 I62 I63 I64
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Residual unilateral arm paresis with one of the listed diagnoses; Completion of acute inpatient treatment and discharge to home for home care or completion of acute inpatient treatment and provision of follow-up treatment followed by discharge to home and home care; Internet-enabled smartphone or tablet with Android (Android 6.0 or higher) or iOS (iOS 11.0 or higher) operating system; Written informed consent regarding study participation and data processing; Ability to speak and understand German; Ability to don the ARYS tracker independently or with the assistance of a relative/caregiver; Physical and cognitive ability to operate the ARYS me app and the ARYS tracker.
Exclusion criteria
Exclusion criteria: Patients participating in other interventional studies; Patients who are in a dependent/employee relationship with the sponsor or investigator; Patients in institutionalization due to court or regulatory order; Patients with schizophrenia (F20), schizoaffective disorder (F25), bipolar affective disorder (F31), intracranial injury (S06), open skin lesions, or skin irritation at the wrist of the paretic arm; Patients who continue treatment in an inpatient care facility after completion of acute inpatient treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ARYS™ me digital application results in greater improvement in paretic arm use between time t0 (baseline) and t2 (post-treatment) according to the Amount of Use (AOU) subscale of the Motor Activity Log - 14 (MAL-14) compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, the secondary endpoints quality of paretic arm use movements (MAL-14 Quality of Movement; QOM), quality of life (Euro Quality of Life 5 Dimension 5 Level; EQ-5D-5L), participation and involvement (Index to Measure Limitations of Participation; IMET), patient autonomy (General Self-Efficacy Short Scale; ASKU), finger dexterity (Nine-Hole Peg Test; NHPT), and manual skills (ABILHAND) will be assessed in the same way. | — |
Countries
Germany
Contacts
BG Klinikum Bergmannstrost Halle