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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Paresis; Neglect, Hemispatial
• Intervention / Treatment: Behavioral: Conventional therapy; Device: E-BRAiN therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Engeli, Prof.Dr.; Phone Number: 5633 +49-3834-86; Email: stefan.engeli@med.uni-greifswald.de
• Study Contact Backup: Name: Franziska Schuster, Dr.rer.nat.; Phone Number: 7420 +49-3834 86; Email: franziska.schuster@med.uni-greifswald.de

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • Recruiting
    • Universitätsmedizin Greifswald
    • Contact: Thomas Platz, Prof.Dr.med.; Phone Number: 490 +49-3834 871; Email: thomas.platz@uni-greifswald.de
    • Sub-Investigator: Ann Loiuse Pedersen, M.D.
  • Greifswald, Germany, 17491
    • Recruiting
    • BDH-Klinik Greifswald
    • Contact: Thomas Platz, Prof.Dr.med.; Phone Number: 490 +49-3835-871; Email: t.platz@bdh-klinik-greifswald.de
    • Sub-Investigator: Ann Louise Pedersen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy; Length of period: 2 weeks	Behavioral: Conventional therapy; Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.
Experimental: Therapy assisted by a humanoid robot (E-BRAiN); Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drop-out rate	Drop-outs	2 weeks
Goal attainment	Goal attainment Scale (GAS)	2 weeks
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
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
Work alliance	Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)	2 weeks
Adverse events	Adverse events documentation for the period of two weeks	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type and frequency of neurorehabilitation therapy received	Therapy documentation for the period of two weeks	2 weeks

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: BDH-Klinik Greifswald
• Investigators: Principal Investigator: Thomas Platz, Prof.Dr.med., Head, Neurorehabilitation Research Group

Publications and helpful links

Helpful Links

• Research web site

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 7, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Paresis; Perceptual Disorders
• Other Study ID Numbers: 202101E-BRAiN; CIV-21-01-035629 (Registry Identifier: EUDAMED)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No