Evidence-Based Robot-Assistant in Neurorehabilitation (E-BRAiN)

University Medicine Greifswald

Status: Enrolling

Conditions: Neglect, Hemispatial; Stroke; Paresis

Treatments: Behavioral: Conventional therapy; Device: E-BRAiN therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05152433

CIV-21-01-035629 (Registry Identifier)

202101E-BRAiN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Conventional therapy

Active Comparator group

Description:

Length of period: 2 weeks

Treatment:

Behavioral: Conventional therapy

Therapy assisted by a humanoid robot (E-BRAiN)

Experimental group

Description:

Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN

Treatment:

Device: E-BRAiN therapy