StrokeE-BRAiNNCT05152433
Evidence-Based Robot-Assistant in Neurorehabilitation
A study testing E-BRAiN therapy and Conventional therapy in people with Stroke and Paresis, run by University Medicine Greifswald at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Paresis, Neglect, Hemispatial
- What is being tested?
- E-BRAiN therapy and Conventional therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesGermany
- Study dates
- 4 Oct 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Franziska Schuster, Dr.rer.nat. contact
Germany2 sites, 2 recruiting
- Recruiting
Universitätsmedizin Greifswald
Greifswald, 17475
Thomas Platz, Prof.Dr.med., +49-3834 871 ext. 490, thomas.platz@uni-greifswald.de
Ann Loiuse Pedersen, M.D.
- Recruiting
BDH-Klinik Greifswald
Greifswald, 17491
Thomas Platz, Prof.Dr.med., +49-3835-871 ext. 490, t.platz@bdh-klinik-greifswald.de
Ann Louise Pedersen
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Paresis, Neglect, Hemispatial
- Being tested
- E-BRAiN therapy, Conventional therapy
- Medical subject headings
- Stroke, Paresis, Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Conventional therapyBehavioural
Conventional therapy specifies the neurorehabilitation therapy as applied as regular treatment.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | Length of period: 2 weeks Receives: 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 Receives: Device: E-BRAiN therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 weeks
Secondary outcomes (6)
Drop-out rate
Drop-outs
Measured: 2 weeks
Goal attainment
Goal attainment Scale (GAS)
Measured: 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)
Measured: 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)
Measured: 2 weeks
Work alliance
Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)
Measured: 2 weeks
Adverse events
Adverse events documentation for the period of two weeks
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start4 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- BDH-Klinik Greifswald
- Responsible party
- Sponsor
- Investigators
- Thomas Platz, Prof.Dr.med., Principal investigator, Head, Neurorehabilitation Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152433
- Sponsor's protocol ID
- 202101E-BRAiN
- Other IDs
- CIV-21-01-035629
- Acronym
- E-BRAiN
- Status last verified
- Dec 2023
- First submitted
- 7 Nov 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-BRAiN - Evidence-Based Robot-Assistant in Neurorehabilitation
- ClinicalTrials.gov ID
- NCT05152433
- Acronym / sponsor ID
- E-BRAiN / 202101E-BRAiN
- Conditions
- Stroke, Paresis, Neglect, Hemispatial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- BDH-Klinik Greifswald
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Behavioral: Conventional therapyLength of period: 2 weeks |
| Therapy assisted by a humanoid robot (E-BRAiN) | Experimental | Device: E-BRAiN therapyLength of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-BRAiN therapyThe 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). | Device | Therapy assisted by a humanoid robot (E-BRAiN) |
| Conventional therapyConventional therapy specifies the neurorehabilitation therapy as applied as regular treatment. | Behavioural | Conventional therapy |
Primary outcome
Change scores over two weeks for the standardised primary outcome measure
Time frame: 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).
6 secondary outcomes
Drop-out rate
Time frame: 2 weeks
Goal attainment
Time frame: 2 weeks
Change scores over two weeks for "Motivation for therapy"
Time frame: 2 weeks
Change scores over two weeks for "Emotional distress"
Time frame: 2 weeks
Work alliance
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Research web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franziska Schuster, Dr.rer.nat. contact
Thomas Platz, Prof.Dr.med. principal investigator
Head, Neurorehabilitation Research Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-BRAiN therapy and Conventional therapy in people with Stroke and Paresis, run by University Medicine Greifswald at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Engeli, Prof.Dr. (+49-3834-86 ext. 5633, stefan.engeli@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores over two weeks for the standardised primary outcome measure (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.