Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions

NCT01418105 | Completed Phase 1 DMC

• 1 other identifier: 85/2010
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Prevention; Rehabilitation

Keywords

spine injuries; brain lesions; dysphagia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (1)

• change of cervical oswestry disability index

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

Study Arms (3)

Videofluroscopic swallow study (VFSS)

ACTIVE COMPARATOR

To investigate the swallowing ability of patients with neurologic problems

Procedure: Videofluroscopic swallow study (VFSS)

cervical spine isometric excercises

ACTIVE COMPARATOR

isometric exercises in patients with cervical spine scoliosis

Procedure: cervical spine isometric exercises

Fiberoptic endoscopic esophageal study (FEES)

ACTIVE COMPARATOR

To investigate the anatomic structures during swallowing of patients with neurologic problems

Procedure: Fiberoptic endoscopic esophageal study (FEES)

Interventions

Videofluroscopic swallow study (VFSS) PROCEDURE

Barium, radiation

Videofluroscopic swallow study (VFSS)

cervical spine isometric exercises PROCEDURE

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

cervical spine isometric excercises

Fiberoptic endoscopic esophageal study (FEES) PROCEDURE

food for swallowing

Fiberoptic endoscopic esophageal study (FEES)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• brain lesions and cervical spine disorders

You may not qualify if:

• age
• peripheral damages

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Greece

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of PMR, Orthopaedic Spine Surgeon

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: August 16, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

GR (1)