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ocomotion after stroke

Not Applicable
Conditions
I63.9
Cerebral infarction, unspecified
Registration Number
DRKS00026799
Lead Sponsor
niklinik Köln
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
90
Inclusion Criteria

written consent, ischaemic stroke, hemiparesis with impaired unilateral leg-motor function

Exclusion Criteria

Subjects who are legally detained in an official institute (§20 MPG), participation in a clinical trial within the last 12 weeks, electronic implants or ferromagnetic implants located in the head, neck or thorax (eg, clips, intracranial shunt, artificial heart valve, pacemaker), medication pump (eg, insulin pump), metal splinters in eye or head, pregnancy/breastfeeding, severe neurodegenerative disease, severe neuroinflammatory disease, history of seizures/epilepsy, physical addiction to alcohol, medication or drugs (excluded: nicotine), insufficient compliance, present or past malignant tumour involving the central nervous system, severe psychiatric disease, clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the corticospinal tract in the hemisphere ipsilateral to the hemiparesis, pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the corticospinal tract, excluding microvascular changes (eg, clinically asymptomatic lacunae <1 cm), known brain lesion (surgical, traumatic), evidence for enhanced cerebral pressure, severe cardiac dysfunction, life expectancy <12 months, National Institutes of Health Stroke Scale Score (NIHSS) >20, blood glucose imbalances resistant to treatment (<50 mg/dL or >300 mg/dL), elevated blood pressure resistant to treatment (>185/110 mm Hg), systemic thrombolysis using alteplase or thrombectomy
within the last 24 hours before enrolment in study, medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalisation or long-term during hospitalisation.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
neuronavigated TMS:<br>M1 (M. tibialis anterior and M. interosseus dorsalis manus) ipsilesionel and contralesionel: alterations in RMT und MEP response patterns in acute and chronic stroke patients.<br><br>Online-rTMS-Intereference:<br>changes in finger and feet tapping parameters after stimulation of M1 foot and hand representation ipsilesional and contralesional<br><br>Additional comparison to/between (young and elderly) healthy control subjects.
Secondary Outcome Measures
NameTimeMethod
Correlation of the extend of electrophysiological alterations and leg function in stroke patients and in healthy control subjects. Additionally, longitudinal observations in chronic stroke patients.<br><br>Stance- and Gait-analysis: <br>Romberg standing test <br>Chair Rising Test <br>Repetition Test<br>Heel Rise Test<br>Gait analysis: fast walking<br><br>clinical scores:<br>Handedness Questionnaire <br>modified Rankin Scale (mRS) <br>Rivermead Mobility Index <br>NIH Stroke Scale (NIHSS)<br>Fugl-Meyer Upper Extremity (FM-UE), Fugl-Meyer Lower Extremity (FM-LE) <br>Short Physical Performance Battery<br>Action Research Arm Test (ARAT) <br>Vigorimeter grip-force , <br>plantarflexion - force <br>finger tapping speed, feet tapping speed <br>Timed-Up-and-Go test (TUG)<br>10 m walk test<br><br>MRT-imaging:<br>structural imaging <br>BOLD fMRT Resting-State-measurement<br>BOLD fMRT during simple motoric task<br>
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