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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00007722 |
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Date of registration:
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03/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The effect of repetitive peripheral magnetic stimulation in stroke-rehabilitation: A randomized controlled trial
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Scientific title:
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The effect of repetitive peripheral magnetic stimulation in stroke-rehabilitation: A randomized controlled trial |
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Date of first enrolment:
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23/09/2014 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting stopped after recruiting started |
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URL:
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http://drks.de/search/en/trial/DRKS00007722 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Kristin
Pohl |
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Address:
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Hermann-Sachse-Straße 46
07639
Bad Klosterlausnitz
Germany |
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Telephone:
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036601/49418 |
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Email:
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kristin.pohl@moritz-klinik.de |
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Affiliation:
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Moritz Klinik Bad Klosterlausnitz |
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Name:
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Kristin
Pohl |
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Address:
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Hermann-Sachse-Straße 46
07639
Bad Klosterlausnitz
Germany |
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Telephone:
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036601/49418 |
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Email:
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kristin.pohl@moritz-klink.de |
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Affiliation:
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Moritz Klinik |
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Key inclusion & exclusion criteria
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Inclusion criteria: subacute stroke (incident not longer than six months back);
spastic hemiparesis (at least modified ashworth scale 1);
a slight function in the fingers or hand (at least 1 point in the Fugl-Meyer-test in subscore C)
Exclusion criteria: Epilepsy, implantated metal in the stimulation area,
implantated medical devices, dysfunctional speech comprehension, pregnancy,
Age minimum:
None
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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G81.1
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Cerebrovascular diseases
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Spastic hemiplegia
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I60-I69
G81.1
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I60-I69
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Intervention(s)
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Group 1: repetitive peripheral magnetic stimulation (rPMS) (interventiongroup):
daily stimulation (mo-fr) for three weeks;
Muscles of the upper arm and forearm are stimulated with a butterfly coil;
The patient takes a sitting position with raised feet in the wheelchair or on a chair with backrest;
The arm is placed to be stimulated or maintained by the therapist;
magnetic stimulator: Magstim Rapid²;
Instruction: Patients are asked to relax and observe their arm
Group 2: peripheral electrical stimulation (controlgroup):
daily stimulation (mo-fr) for three weeks
Muscles of the upper arm and forearm are stimulated with electrodes;
The patient takes a sitting position with raised feet in the wheelchair or on a chair with backrest;
The arm is placed to be stimulated or maintained by the therapist;
Electrical device: wellcare digi stim
Instruction: Patients are asked to relax and observe their arm
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Primary Outcome(s)
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group difference in Fugl-Meyer-Score three weeks post stimulation
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Secondary Outcome(s)
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group difference in Katz Index of Independence of daily living scale (ADL) score after six months
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Source(s) of Monetary Support
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Moritz Klinik
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Ethics review
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Status: Approved
Approval date: 21/08/2014
Contact:
ethikkommission@med.uni-jena.de
Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
+49-3641-9391191
ethikkommission@med.uni-jena.de
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