Overview
The purpose of this study is to investigate the efficacy, acceptability, and safety of the therapeutic system E-BRAiN for the treatment of stroke-related impairments.
Description
This randomized controlled trial, RCT with cross-over design sequentially allocates participants with stroke-related impairment to both a two week course of conventional rehabilitation therapy and a two week course of therapy using the therapy system E-BRAiN (purpose-built therapy system using a socially interactive humanoid robot); participants are randomly allocated to the sequences "conventional => robot" or "robot => conventional". Stroke survivors with one of the target syndromes, i.e. mild arm paresis, or moderate to severe arm paresis, or visuospatial neglect are invited to participate.
Eligibility
Inclusion Criteria:
- Age at study entry ≥ 18 years
- Stroke (ischemic stroke, non-traumatic intracerebral haemorrhage, subarachnoidal haemorrhage)
- Incomplete arm paresis (Motricity Index, arm score >1 [Min] and < 100 [Max]) or
- Visuospatial neglect (clinical signs and NET subtest "star cancellation" score < 50)
- Candidate able to consent and provides informed consent or
- legal representative provides informed consent
Exclusion Criteria:
- Pregnant or breast feeding
- Obliged to live in an institution by law or public authority
- With case presentation arm paresis: another condition that causes arm paresis is present
- With case presentation visuospatial neglect: another condition that causes a relevant visual-perceptual deficit that cannot be compensated is present; exception: homonymous visual field deficits are not an exclusion criterion