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Completed

NCT Number: NCT01418105

Dysphagia and Cervical Spine Disorders in Patients With 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.

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Key information

Conditions

Prevention Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Rehabilitation

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Ioannina

Ioannina, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • brain lesions and cervical spine disorders

Exclusion criteria

  • age
  • peripheral damages

Treatment and study plan

Videofluroscopic swallow study (VFSS)

Procedure

Barium, radiation

cervical spine isometric exercises

Procedure

patients with cervical scoliosis will execute isometric exercises of the cervical spine

Fiberoptic endoscopic esophageal study (FEES)

Procedure

food for swallowing

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions

Acronym: DysphagCerv

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Aug 16, 2011
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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