CVA / beroerte CVA stroke
Conditions
Interventions
In the intervention condition participants will wear the system for two weeks
while receiving direct feedback on arm use from the device and coaching on
objectively measured arm use from a therapist
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - People that suffered from an ischemic or hemorrhagic unilateral stroke more than one week ago and less than six months ago. - The stroke resulted in new reduced upper limb function on one side. - Age: 18 years or older. - Subjects have to be able to lift the paretic arm against gravity. - Inpatient in rehabilitation institute. - Participants have to be able to do on/off the devices on both wrists independently or with the assistance of a caregiver. - Participants need to be able to provide informed consent as documented by signature. - The patient is planned to stay in the rehabilitation institute for at least five weeks from the start of the study Amendment: To evaluate the extended aims, we aim to include 12 additional participants with same characteristics but that are: -Getting outpatient treatment in a rehabilitation institute or planned to received outpatient treatment in a rehabilitation institute, for at least five weeks from the moment of inclusion.
Exclusion criteria
Exclusion criteria: - Severely reduced upper limb function which results in inability to lift the affected hand off the lap when sitting. - Upper limb complications (e.g. frozen shoulder, severe upper limb pain). - Participants cannot comply with the study as a result of significant cognitive, communication or visual impairment. - Severely impaired sensation resulting in inability to sense vibro-tactile triggers from the arm activity tracker. - Severely impaired vision which results in inability to read messages from the display of the hand activity tracker. - Comprehensive aphasia which results in inability to read and/or understand messages from the display of the hand activity tracker. - Potential non-compliance, such as known intolerance to the device material, major comorbidities (e.g. cardiopulmonary disease, orthopaedic disorders of the upper limb). - Major depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is feasibility of the intervention based on the Arm Activity Tracker. The following feasibility parameters will be evaluated: 1) technical and operational feasibility of the device, 2) user acceptance, 3) adherence during the intervention. Amendment: - We will extend the evaluation of the feasibility parameter *user acceptance* by also determining how contextual, social and personal factors influence the user acceptance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter is the difference in objectively measured arm use in daily life between the intervention condition and control condition. Amendment: - We will extend the secondary study parameter by also investigating the patient characteristics that have an impact on the changes observed in the objectively measured arm use in daily life. | — |
Countries
Netherlands
Outcome results
None listed