Evidence-Based Robot-Assistant in Neurorehabilitation

NCT ID: NCT05152433

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Paresis Neglect, Hemispatial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional therapy

Length of period: 2 weeks

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type BEHAVIORAL

Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.

Therapy assisted by a humanoid robot (E-BRAiN)

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

Group Type EXPERIMENTAL

E-BRAiN therapy

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Conventional therapy

Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BDH-Klinik Greifswald

UNKNOWN

Sponsor Role collaborator

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Platz, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Head, Neurorehabilitation Research Group

Locations

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Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status RECRUITING

BDH-Klinik Greifswald

Greifswald, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Engeli, Prof.Dr.

Role: CONTACT

Phone: +49-3834-86

Email: [email protected]

Franziska Schuster, Dr.rer.nat.

Role: CONTACT

Phone: +49-3834 86

Email: [email protected]

Facility Contacts

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Thomas Platz, Prof.Dr.med.

Role: primary

Thomas Platz, Prof.Dr.med.

Role: primary

Related Links

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Other Identifiers

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CIV-21-01-035629

Identifier Type: REGISTRY

Identifier Source: secondary_id

202101E-BRAiN

Identifier Type: -

Identifier Source: org_study_id