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Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions (DysphagCerv)

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ClinicalTrials.gov Identifier: NCT01418105
Recruitment Status : Completed
First Posted : August 16, 2011
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

July 28, 2011
August 16, 2011
October 26, 2016
January 2011
October 2016   (Final data collection date for primary outcome measure)
  • change in swallowing ability and quality of life by swal-quol questionnaire [ Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year ]
  • change of swallowing ability by Okuma's questionnaire [ Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year ]
  • change of cervical scoliosis measured by Cobb method in x-rays [ Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year ]
Same as current
Complete list of historical versions of study NCT01418105 on ClinicalTrials.gov Archive Site
change of cervical oswestry disability index [ Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year ]
this questionnaire will be distributed only to patients with previous cervical spine problems
Same as current
Not Provided
Not Provided
 
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
The research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. Three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. After the bedside examination, VFSS or FEES, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. The results will be collected and evaluated using the statistical programme SPSS.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
  • Prevention
  • Rehabilitation
  • Procedure: Videofluroscopic swallow study (VFSS)
    Barium, radiation
  • Procedure: cervical spine isometric exercises
    patients with cervical scoliosis will execute isometric exercises of the cervical spine
  • Procedure: Fiberoptic endoscopic esophageal study (FEES)
    food for swallowing
  • Active Comparator: Videofluroscopic swallow study (VFSS)
    To investigate the swallowing ability of patients with neurologic problems
    Intervention: Procedure: Videofluroscopic swallow study (VFSS)
  • Active Comparator: cervical spine isometric excercises
    isometric exercises in patients with cervical spine scoliosis
    Intervention: Procedure: cervical spine isometric exercises
  • Active Comparator: Fiberoptic endoscopic esophageal study (FEES)
    To investigate the anatomic structures during swallowing of patients with neurologic problems
    Intervention: Procedure: Fiberoptic endoscopic esophageal study (FEES)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
100
October 2016
October 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • brain lesions and cervical spine disorders

Exclusion Criteria:

  • age
  • peripheral damages
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01418105
85/2010
Yes
Not Provided
Not Provided
Avraam Ploumis, University of Ioannina
University of Ioannina
Not Provided
Not Provided
University of Ioannina
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP