Stroke Wearable Operative Rehabilitation Device Impact Trial "SWORD-IT"


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- More than 18 years old at stroke onset, with no superior age limit;
- Medical diagnosis of acute ischemic stroke;
- First ever stroke;
- Previously independent, defined as having a modified Rankin scale (mRS) of 0-1;
- Clinical and CT or MRI compatible with a medial cerebral artery ischemic lesion;
- Confirmed motor deficit on the upper limb but not plegia (able to actively extend wrist, thumb, and at least 2 other digits >10°), defined as a score between 0 and 2 on items 5a or 5b of the National Institute of Health Stroke Scale;
- Inpatients, within no more than 4 weeks after stroke onset;
- Medically stable, no intravenous medication and already able to sit for more than one hour comfortably;
- Favourable opinion of the attending stroke physician;
- Patient and caregiver understand the purpose of the study and provided written informed consent.

Exclusion Criteria

- No detectable motor deficits at baseline assessment by the neurologist;
- Severe aphasia;
- Dementia (any stage);
- Other cognitive or psychiatric comorbidity that impairs communication or compliance with the tasks;
- Severe respiratory or cardiac condition incompatible with more than one minute of continuous mild exercise (e.g. combing hair) in a sitting position;
- Pain that limits upper limb movement either on the normal or affected side;
- Upper limb amputation or severe deformity either on the normal or affected side;
- Fixed articular limitations of upper limb either on the normal or affected side;
- Enrollment in other trial in the previous 3 months.