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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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 therapy specifies the neurorehabilitation therapy as applied as regular treatment.
Universitätsmedizin Greifswald
Greifswald, Germany
RECRUITINGBDH-Klinik Greifswald
Greifswald, Germany
RECRUITINGChange 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).
Time frame: 2 weeks
Drop-out rate
Drop-outs
Time frame: 2 weeks
Goal attainment
Goal attainment Scale (GAS)
Time frame: 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)
Time frame: 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)
Time frame: 2 weeks
Work alliance
Assessment of the perceived work alliance for the period of two weeks prior using the Work Alliance Inventory (WAI)
Time frame: 2 weeks
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Adverse events
Adverse events documentation for the period of two weeks
Time frame: 2 weeks