Evidence-Based Robot-Assistant in Neurorehabilitation
- Conditions
- StrokeNeglect, HemispatialParesis
- Interventions
- Device: E-BRAiN therapyBehavioral: Conventional therapy
- Registration Number
- NCT05152433
- Lead Sponsor
- University Medicine Greifswald
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Therapy assisted by a humanoid robot (E-BRAiN) E-BRAiN therapy Length of period: 2 weeks Fixed dose: 10 therapy sessions with E-BRAiN Conventional therapy Conventional therapy Length of period: 2 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method Work alliance 2 weeks Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)
Drop-out rate 2 weeks Drop-outs
Goal attainment 2 weeks Goal attainment Scale (GAS)
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)
Adverse events 2 weeks Adverse events documentation for the period of two weeks
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)
Trial Locations
- Locations (2)
BDH-Klinik Greifswald
🇩🇪Greifswald, Germany
Universitätsmedizin Greifswald
🇩🇪Greifswald, Germany