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ISRCTN
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ISRCTN17141238
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial (RCT): Conservative voice treatment (CVT) versus electrostimulation therapy (EST) for unilateral vocal cord paresis (UVCP)
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Scientific title
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Acronym
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CVT vs EST in UVCP: RCT
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Serial number at source
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N/A
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Study hypothesis
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Added as of 10/12/2008:
Electrical stimulation therapy is as effective as voice therapy in patients with unilateral recurrent laryngeal nerve paresis.
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Lay summary
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Ethics approval
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The study was approved by the Ethics Committee of the Hannover Medical School.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Vocal cord paresis
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Participants - inclusion criteria
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Patients with unilateral vocal cord paresis
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Participants - exclusion criteria
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Added as of 10/12/2008:
1. Voice therapy or any other therapy prior to T0
2. Paresis onset less than 2 weeks or more than 6 months prior to therapy
3. Age under 18 years
4. Paresis following resection of the recurrent nerve
5. Pareses due to muscle or joint injuries
6. Hearing loss 40 dB in the 500–3000 Hz range
7. Presence of other conditions possibly interfering with the therapy, such as cognitive deficits or other serious diseases
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Anticipated start date
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01/01/2003
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Anticipated end date
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31/12/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Added as of 10/12/2008: 90
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Interventions
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Conservative voice treatment versus electrostimulation therapy
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Added as of 10/12/2008:
Hannover Medical School, Clinical Department of Communication Disorders (Germany)
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Trial website
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Publications
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2008 final results in http://www.ncbi.nlm.nih.gov/pubmed/18642381
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Contact name
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Prof
Martin
Ptok
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Address
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Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str.1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Tel
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+49 (0)511 532 9104
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Email
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Ptok.Martin@MH-Hannover.de
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Sponsor
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Phoniatry and Paedaudiology Clinic, Hannover Medical School (Germany)
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Address
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Martin Ptok
Klinik für Phoniatrie und Pädaudiologie
Medizinische Hochschule Hannover - OE 6510
C.-Neuberg-Str. 1
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City/town
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Hannover
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Zip/Postcode
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30625
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Country
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Germany
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Sponsor website:
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http://www.MH-Hannover.de
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Date applied
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13/09/2004
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Last edited
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10/12/2008
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Date ISRCTN assigned
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11/10/2004
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