Trial document





This trial has been registered retrospectively.
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  DRKS00017480

Trial Description

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Title

PhagoStim. Dysphagia Treatment with Neuromuscular Electrostimulation – A randomized Trial

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study was to compare the effect of electric stimulation combined with regular swallowing therapy and regular swallowing therapy in combination with sham stimulation in patients with dysphagia.

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Brief Summary in Scientific Language

The aim of this study was to compare the effect of neuromuscular electrostimulation (NMES) in addition to Traditional Dysphagia Treatment (TDT) with sham stimulation and TDT in patients with mild to severe dysphagia (level 1-5) during the post-acute phase.
Twelve patients were enrolled in a prospective randomized pilot study. 1 Group of patients underwent NMES and TDT and 1 other Group of patients received sham stimulation and TDT. All subjects received treatment sessions over a period of four weeks, 5 days per week, twice per day for 20 min. Sessions consisted of TDT in combination with NMES or sham stimulation.

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Organizational Data

  •   DRKS00017480
  •   2019/06/18
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  •   yes
  •   Approved
  •   6068-2012, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

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Health Condition or Problem studied

  •   R13 -  Dysphagia
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Interventions/Observational Groups

  •   neuromuscular electrical Stimulation + traditional dysphagia therapy
  •   sham stimulation + traditional dysphagia therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Baseline and post-trial measurements were done by Fiberoptic endoscopic evaluation of swallowing (FEES) in combination with Dysphagia Outcome and Severity Scale (DOSS) (primary outcome measure).

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Secondary Outcome

Secretion Scale by Murray,
Glottic closure by Murray,
Penetration and Aspiration Scale (PAS) and throat clearance abilities.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/01/23
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

male and female patients with dysphagia after stroke, post-acute phase

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Exclusion Criteria

Non-consent, pregnancy, diseases of the upper esophageal sphincter, tumors, pacemakers, cranial stimulators as well as metal implants in the head and neck represented as exclusion criteria.

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Addresses

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    • Medizinische Hochschule Hannover
    • Mr.  Prof. Dr. med. Dr. med. h.c.  Martin  Prok 
    • Carl-neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Simone  Miller 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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    • Medizinische Hochschule Hannover
    • Ms.  Dr.  Simone  Miller 
    • Carl-Neuberg-Straße 1
    • 30625  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • AIF Projekt GmbH
    • Tschaikowskistraße 49
    • 13156  Berlin
    • Germany
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    •   +4930481633
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    • Personal teilw. durch teilnehmende Einrichtungen KRH Geriatrie Langenhagen
    • Rohdehof 3
    • 30853  Langenhagen
    • Germany
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    •   +49 511 7300 499
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    • Personal teilw. durch teilnehmende Einrichtungen: Klinik Niedersachsen
    • Hauptstraße 59
    • 31542  Bad Nenndorf
    • Germany
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    • Personal teilw. durch teilnehmende Einrichtungen: Medizinische Hochschule Hannover
    • C.-Neuberg Str. 1
    • 30625  hannover
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/04/02
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Trial Publications, Results and other Documents

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