NCT05152433

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

November 7, 2021

Last Update Submit

December 7, 2023

Conditions

StrokeParesisNeglect, Hemispatial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Drop-out rate

    2 weeks

  • Goal attainment

    2 weeks

  • Change scores over two weeks for "Motivation for therapy"

    2 weeks

  • Change scores over two weeks for "Emotional distress"

    2 weeks

  • Work alliance

    2 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Type and frequency of neurorehabilitation therapy received

    2 weeks

Study Arms (2)

Conventional therapy

ACTIVE COMPARATOR

Length of period: 2 weeks

Behavioral: Conventional therapy

Therapy assisted by a humanoid robot (E-BRAiN)

EXPERIMENTAL

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

Device: E-BRAiN therapy

Interventions

E-BRAiN therapyDEVICE

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).

Therapy assisted by a humanoid robot (E-BRAiN)
Conventional therapyBEHAVIORAL

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

Conventional therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

RECRUITING

BDH-Klinik Greifswald

Greifswald, 17491, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

StrokeParesisPerceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurobehavioral Manifestations

Study Officials

  • Thomas Platz, Prof.Dr.med.

    Head, Neurorehabilitation Research Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Engeli, Prof.Dr.

CONTACT

+49-3834-86stefan.engeli@med.uni-greifswald.de

Franziska Schuster, Dr.rer.nat.

CONTACT

+49-3834 86franziska.schuster@med.uni-greifswald.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2021

First Posted

December 9, 2021

Study Start

October 4, 2021

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)