Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere.
Chronic stroke patients (\> 6 months) with severe motor impairment of the upper extremity and non-proportional recovery will be enrolled in this single-centre, randomized controlled clinical trial (RCT). All patients will take part in two blocks of high-intense motor training with concurrent neuromuscular stimulation of the paretic upper extremity. In a randomized, cross-over block design, patients will receive transcranial stimulation of either the ipsi- or contralesional hemisphere. The primary outcome measure is the Fugl-Meyer Assessment for upper extremity (FM-UE), acquired at baseline, after the intervention period, and at 3 months follow-up. Secondary outcome measures consist of further clinical parameters and biomarkers of corticospinal connectivity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle
University Hospital Tübingen
Tübingen, Baden-Wurttemberg, Germany
Fugl-Meyer Assessment (Upper Extremity)
Time frame: change from baseline to both directly after intervention and 3 months after
Action Research Arm Test (ARAT)
Motor Impairment of the upper extremity. Several objects in different sizes and weights should be moved by patients.
Time frame: change from baseline to both directly after intervention and 3 months after
Arm-A
Questionnaire on capability to care for the paretic arm in different situations of daily living. Scale ranges from 0 (no problems) to 4 (impossible to do).
Time frame: change from baseline to both directly after intervention and 3 months after
Modified Ashworth Scale (MAS)
Spasticity in different body parts. Scale ranges from 0 (no spasticity) to 4 (rigid).
Time frame: change from baseline to both directly after intervention and 3 months after
Fugl-Meyer Assessment (Lower Extremity)
Assessment of motor impairment of the lower extremity.
Time frame: change from baseline to both directly after intervention and 3 months after
10m walking test
Assessment of motor impairment of the lower extremity.
Time frame: change from baseline to both directly after intervention and 3 months after
National Institute of Stroke Scale (NIHSS)
Assessment of severity of stroke and neurological deficits. Scale ranges from 0 (normal) to 2, 3 or 4 (depending on the item).
Time frame: baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Modified Rankin Scale (mRS)
Degree of disability after stroke on a scale from 0 (no symptoms) to 6 (dead).
Time frame: change from baseline to both directly after intervention and 3 months after
EQ-5D
Questionnaire on subjective health status. Patients should rate their health status for that day in different tasks of daily living on a scale from no problems, minor problems, moderate problems, big problems to not possible at all.
Time frame: change from baseline to both directly after intervention and 3 months after
CAHAI-13
Test on activities of daily living. Patients should perform several tasks and are scored from 1 (total assist) to 7 (complete independence).
Time frame: change from baseline to both directly after intervention and 3 months after
Stroke Impact Scale
Questionnaire on subjective impact of stroke on daily living and health status. Scale ranges from 1 (most negative answer) to 5 (most positive answer).
Time frame: change from baseline to both directly after intervention and 3 months after
Barthel Index
Questionnaire on extent to which patients can perform activities of daily living on their own. Patients can reach 0 (cannot perform any task) to a maximum of 100 points (can do everything on their own).
Time frame: change from baseline to both directly after intervention and 3 months after
Hospital Anxiety and Depression Scale
Questionnaire on anxiety and depression. Scale ranges from 0 (most positive answer) to 3 (most negative answer).
Time frame: change from baseline to both directly after intervention and 3 months after
Neurological Fatigue Index
Questionnaire on fatigue in the last two weeks. Scale ranges from no agreement at all, no agreement, agreement to some extent to full agreement.
Time frame: change from baseline to both directly after intervention and 3 months after
NEO-Fünf-Faktoren Inventar
Personality questionnaire with 60 statements that patients should rate ranging from strong disagreement, disagreement, neutral, agreement to strong agreement.
Time frame: baseline
Situational Motivation Scale
Questionnaire on motivation to participate in training. Scale ranges from 0 (not correct at all) to 6 (strongly agree).
Time frame: change from baseline to both directly after intervention and 3 months after
Berlin Social Support Scale
Questionnaire to evaluate social support. Patients should rate different questions regarding their most important attachment figure ranging from no agreement at all, no agreement, agreement to some extent to full agreement.
Time frame: change from baseline to both directly after intervention and 3 months after
Credibility/Expectancy Questionnaire
Questionnaire to evaluate expectancies on current program. Scale rangs from 0 (most negative) to 9 (most positive).
Time frame: change from baseline to both directly after intervention and 3 months after