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

Sponsor
University Medicine Greifswald (Other)
Overall Status
Recruiting
CT.gov ID
NCT05152433
Collaborator
BDH-Klinik Greifswald (Other)
40
2
2
10.9
20
1.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: E-BRAiN therapy
  • Behavioral: Conventional therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
Actual Study Start Date :
Oct 4, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Change scores over two weeks for the standardised primary outcome measure [2 weeks]

    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).

Secondary Outcome Measures

  1. Drop-out rate [2 weeks]

    Drop-outs

  2. Goal attainment [2 weeks]

    Goal attainment Scale (GAS)

  3. Change scores over two weeks for "Motivation for therapy" [2 weeks]

    Change scores are difference scores for assessments taken two weeks apart with Visual Analogue Scales (VAS) for motivational factors (Min 0, Max 100)

  4. Change scores over two weeks for "Emotional distress" [2 weeks]

    Change scores are difference scores for assessments taken two weeks apart with the Hospital Anxiety and Depression Scale (HADS)

  5. Work alliance [2 weeks]

    Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)

  6. Adverse events [2 weeks]

    Adverse events documentation for the period of two weeks

Other Outcome Measures

  1. Type and frequency of neurorehabilitation therapy received [2 weeks]

    Therapy documentation for the period of two weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsmedizin Greifswald Greifswald Germany 17475
2 BDH-Klinik Greifswald Greifswald Germany 17491

Sponsors and Collaborators

  • University Medicine Greifswald
  • BDH-Klinik Greifswald

Investigators

  • Principal Investigator: Thomas Platz, Prof.Dr.med., Head, Neurorehabilitation Research Group

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT05152433
Other Study ID Numbers:
  • 202101E-BRAiN
  • CIV-21-01-035629
First Posted:
Dec 9, 2021
Last Update Posted:
Dec 9, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 9, 2021