Stimulating the motivation of patients with residual unilateral arm paresis after stroke to increase arm activity in the home setting using a digital applicatio

Not Applicable

• Conditions: G81; G45; I60; I61; I62; I63; I64; Hemiplegia; Transient cerebral ischaemic attacks and related syndromes; Subarachnoid haemorrhage

• Registration Number: DRKS00027571
• Lead Sponsor: Tyromotion GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-07
• Study Completion: 2023-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 7

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.