A pilot study to investigate the feasibility of an intervention based on the Arm Activity Tracker in stroke patients.

• Conditions: CVA / beroerte; CVA; stroke

• Registration Number: NL-OMON50142
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

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.
- Inpatient in rehabilitation institute.
- Subjects have to be able to lift the paretic arm against gravity.
- 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is feasibility of the intervention based on the Arm<br /><br>Activity Tracker. The following feasibility parameters will be evaluated: 1)<br /><br>technical and operational feasibility of the device, 2) user acceptance, 3)<br /><br>adherence during the intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameter is the difference in objectively measured arm use in<br /><br>daily life between the intervention condition and control condition. </p><br>