Using a robot assistant for neurorehabilitation after stroke
E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
NA · University Medicine Greifswald · NCT05152433
This study is testing whether using a robot assistant can help stroke survivors recover better from arm weakness and other challenges compared to regular therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medicine Greifswald (other) |
| Locations | 2 sites (Greifswald and 1 other locations) |
| Trial ID | NCT05152433 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness, acceptability, and safety of the E-BRAiN therapeutic system, which utilizes a socially interactive humanoid robot, for treating impairments resulting from strokes. Participants will be randomly assigned to receive either conventional rehabilitation therapy or therapy with the E-BRAiN system over two-week periods, with a crossover design allowing each participant to experience both therapies. The study aims to assess improvements in conditions such as arm paresis and visuospatial neglect among stroke survivors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke and exhibit mild to moderate arm paresis or visuospatial neglect.
Not a fit: Patients who are pregnant, breastfeeding, or have other conditions causing arm paresis or significant visual-perceptual deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance rehabilitation outcomes for stroke survivors, leading to improved recovery of motor and cognitive functions.
How similar studies have performed: Other studies have shown promise in using robotic systems for rehabilitation, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Greifswald and 1 other locations
- Universitätsmedizin Greifswald — Greifswald, Germany (RECRUITING)
- BDH-Klinik Greifswald — Greifswald, Germany (RECRUITING)
Study contacts
- Principal investigator: Thomas Platz, Prof.Dr.med. — Head, Neurorehabilitation Research Group
- Study coordinator: Stefan Engeli, Prof.Dr.
- Email: stefan.engeli@med.uni-greifswald.de
- Phone: +49-3834-86
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Paresis, Neglect, Hemispatial