Evidence-Based Robot-Assistant in Neurorehabilitation

Stroke Clinical Trial

— E-BRAiN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152433
• Other study ID #: 202101E-BRAiN
• Secondary ID: CIV-21-01-035629
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University Medicine Greifswald
• Contact: Stefan Engeli, Prof.Dr.
• Phone: +49-3834-86
• Email: stefan.engeli[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neglect, Hemispatial
• Paresis
• Perceptual Disorders
• Stroke

Intervention

Device:
• E-BRAiN therapy
The therapy system E-BRAiN is a purpose-built therapy system using a socially interactive humanoid robot and provides individualised therapy for arm rehabilitation based on the evidence-based therapies arm basis training, arm ability training, or mirror therapy for arm rehabilitation (paresis) or neurovisual training (neglect).

Behavioral:
• Conventional therapy
Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.

Locations

Country	Name	City	State
Germany	BDH-Klinik Greifswald	Greifswald
Germany	Universitätsmedizin Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	BDH-Klinik Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type and frequency of neurorehabilitation therapy received	Therapy documentation for the period of two weeks	2 weeks
Primary	Change scores over two weeks for the standardised primary outcome measure	Change scores are difference scores for assessments taken two weeks apart. Changes scores are based on standardised outcome measures. Assessment scores for each measure (see below) are standardised using the known variance in stroke survivor populations for the respective measure.; The following assessments will be used for standardised outcome measures: Nine-Hole-Peg-Test, NHPT (finger dexterity) and Box-and-Block Test, BBT (gross manual dexterity) (for participants with mild arm paresis); Fugl Meyer, Arm motor score, FM Arm (selective arm and hand movement capacity) (participants with moderate to severe arm paresis); Neglect-Test, NET (spatial visual attention) (participants with visual neglect).	2 weeks
Secondary	Drop-out rate	Drop-outs	2 weeks
Secondary	Goal attainment	Goal attainment Scale (GAS)	2 weeks
Secondary	Change scores over two weeks for "Motivation for therapy"	Change scores are difference scores for assessments taken two weeks apart with Visual Analogue Scales (VAS) for motivational factors (Min 0, Max 100)	2 weeks
Secondary	Change scores over two weeks for "Emotional distress"	Change scores are difference scores for assessments taken two weeks apart with the Hospital Anxiety and Depression Scale (HADS)	2 weeks
Secondary	Work alliance	Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)	2 weeks
Secondary	Adverse events	Adverse events documentation for the period of two weeks	2 weeks

External Links

•   Research web site