Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions

Rehabilitation Clinical Trial

— DysphagCerv  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418105
• Other study ID #: 85/2010
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2011
• Last updated: October 24, 2016
• Start date: January 2011
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: GREECE: 'National Drug Organisation'
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• brain lesions and cervical spine disorders

Exclusion Criteria:

• age

• peripheral damages

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Deglutition Disorders
• Prevention
• Rehabilitation
• Spinal Diseases

Intervention

Procedure:
• Videofluroscopic swallow study (VFSS)
Barium, radiation
• cervical spine isometric exercises
patients with cervical scoliosis will execute isometric exercises of the cervical spine
• Fiberoptic endoscopic esophageal study (FEES)
food for swallowing

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in swallowing ability and quality of life by swal-quol questionnaire		at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year	No
Primary	change of swallowing ability by Okuma's questionnaire		at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year	No
Primary	change of cervical scoliosis measured by Cobb method in x-rays		at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year	No
Secondary	change of cervical oswestry disability index	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	No