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

October 24, 2016 updated by: Avraam Ploumis, University of Ioannina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Ioannina, Greece
        • University Hospital of Ioannina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • brain lesions and cervical spine disorders

Exclusion Criteria:

  • age
  • peripheral damages

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ioannina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 28, 2011

First Submitted That Met QC Criteria

August 15, 2011

First Posted (Estimate)

August 16, 2011

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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