Evidence-Based Robot-Assistant in Neurorehabilitation (E-BRAiN)
Primary Purpose
Stroke, Paresis, Neglect, Hemispatial
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
E-BRAiN therapy
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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
Sites / Locations
- Universitätsmedizin GreifswaldRecruiting
- BDH-Klinik GreifswaldRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional therapy
Therapy assisted by a humanoid robot (E-BRAiN)
Arm Description
Length of period: 2 weeks
Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Drop-out rate
Drop-outs
Goal attainment
Goal attainment Scale (GAS)
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)
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)
Work alliance
Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)
Adverse events
Adverse events documentation for the period of two weeks
Full Information
NCT ID
NCT05152433
First Posted
November 7, 2021
Last Updated
December 7, 2021
Sponsor
University Medicine Greifswald
Collaborators
BDH-Klinik Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT05152433
Brief Title
Evidence-Based Robot-Assistant in Neurorehabilitation
Acronym
E-BRAiN
Official Title
E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
Collaborators
BDH-Klinik Greifswald
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Paresis, Neglect, Hemispatial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Length of period: 2 weeks
Arm Title
Therapy assisted by a humanoid robot (E-BRAiN)
Arm Type
Experimental
Arm Description
Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN
Intervention Type
Device
Intervention Name(s)
E-BRAiN therapy
Intervention Description
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
Behavioral
Intervention Name(s)
Conventional therapy
Intervention Description
Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.
Primary Outcome Measure Information:
Title
Change scores over two weeks for the standardised primary outcome measure
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Drop-out rate
Description
Drop-outs
Time Frame
2 weeks
Title
Goal attainment
Description
Goal attainment Scale (GAS)
Time Frame
2 weeks
Title
Change scores over two weeks for "Motivation for therapy"
Description
Change scores are difference scores for assessments taken two weeks apart with Visual Analogue Scales (VAS) for motivational factors (Min 0, Max 100)
Time Frame
2 weeks
Title
Change scores over two weeks for "Emotional distress"
Description
Change scores are difference scores for assessments taken two weeks apart with the Hospital Anxiety and Depression Scale (HADS)
Time Frame
2 weeks
Title
Work alliance
Description
Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)
Time Frame
2 weeks
Title
Adverse events
Description
Adverse events documentation for the period of two weeks
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Type and frequency of neurorehabilitation therapy received
Description
Therapy documentation for the period of two weeks
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Engeli, Prof.Dr.
Phone
+49-3834-86
Ext
5633
Email
stefan.engeli@med.uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Franziska Schuster, Dr.rer.nat.
Phone
+49-3834 86
Ext
7420
Email
franziska.schuster@med.uni-greifswald.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Platz, Prof.Dr.med.
Organizational Affiliation
Head, Neurorehabilitation Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Platz, Prof.Dr.med.
Phone
+49-3834 871
Ext
490
Email
thomas.platz@uni-greifswald.de
First Name & Middle Initial & Last Name & Degree
Ann Loiuse Pedersen, M.D.
Facility Name
BDH-Klinik Greifswald
City
Greifswald
ZIP/Postal Code
17491
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Platz, Prof.Dr.med.
Phone
+49-3835-871
Ext
490
Email
t.platz@bdh-klinik-greifswald.de
First Name & Middle Initial & Last Name & Degree
Ann Louise Pedersen
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.ebrain-science.de/en/home/
Description
Research web site
Learn more about this trial
Evidence-Based Robot-Assistant in Neurorehabilitation
We'll reach out to this number within 24 hrs