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

This study is currently recruiting participants.
Verified May 2013 by University of Ioannina
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina
ClinicalTrials.gov Identifier:
NCT01418105
First received: July 28, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Prevention
Rehabilitation
 Procedure: Videofluroscopic swallow study (VFSS)
Procedure: cervical spine isometric exercises
Procedure: Fiberoptic endoscopic esophageal study (FEES)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
Official Title: Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change of cervical oswestry disability index [ Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year ] [ Designated as safety issue: No ]
    this questionnaire will be distributed only to patients with previous cervical spine problems


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Videofluroscopic swallow study (VFSS)
To investigate the swallowing ability of patients with neurologic problems
 Procedure: Videofluroscopic swallow study (VFSS)
Barium, radiation
Active Comparator: cervical spine isometric excercises
isometric exercises in patients with cervical spine scoliosis
 Procedure: cervical spine isometric exercises
patients with cervical scoliosis will execute isometric exercises of the cervical spine
Active Comparator: Fiberoptic endoscopic esophageal study (FEES)
To investigate the anatomic structures during swallowing of patients with neurologic problems
 Procedure: Fiberoptic endoscopic esophageal study (FEES)
food for swallowing

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • brain lesions and cervical spine disorders

Exclusion Criteria:

  • age
  • peripheral damages
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418105

Contacts
Contact: Soultana Papadopoulou soultpap@yahoo.gr

Locations
Greece
University Hospital of Ioannina Recruiting
Ioannina, Greece
Contact: Soultana Papadopoulou, SLT         soultpap@yahoo.gr    
Principal Investigator: Avraam Ploumis, Assist Professor            
Sub-Investigator: Soultana Papadopoulou, SLP            
Sponsors and Collaborators
University of Ioannina
  More Information

No publications provided

Responsible Party: Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina
ClinicalTrials.gov Identifier: NCT01418105     History of Changes
Other Study ID Numbers: 85/2010
Study First Received: July 28, 2011
Last Updated: May 1, 2013
Health Authority: GREECE: 'National Drug Organisation'

Keywords provided by University of Ioannina:
spine injuries
brain lesions
dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Spinal Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Pharyngeal Diseases
Otorhinolaryngologic Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013