Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions

Phase 1

Completed

• Conditions: Rehabilitation; Prevention
• Interventions: Procedure: Fiberoptic endoscopic esophageal study (FEES); Procedure: Videofluroscopic swallow study (VFSS); Procedure: cervical spine isometric exercises

• Registration Number: NCT01418105
• Lead Sponsor: University of Ioannina

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-15
• Study First Posted: 2011-08-16
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• brain lesions and cervical spine disorders

Exclusion Criteria

• age
• peripheral damages

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fiberoptic endoscopic esophageal study (FEES)	Fiberoptic endoscopic esophageal study (FEES)	To investigate the anatomic structures during swallowing of patients with neurologic problems
Videofluroscopic swallow study (VFSS)	Videofluroscopic swallow study (VFSS)	To investigate the swallowing ability of patients with neurologic problems
cervical spine isometric excercises	cervical spine isometric exercises	isometric exercises in patients with cervical spine scoliosis

Primary Outcome Measures

Name	Time	Method
change of swallowing ability by Okuma's questionnaire	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	at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
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

Secondary Outcome Measures

Name	Time	Method
change of cervical oswestry disability index	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

Trial Locations

Locations (1)

University Hospital of Ioannina; 🇬🇷 Ioannina, Greece