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Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions

NCT ID: NCT01418105

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-10-31

Brief Summary

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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

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Conditions

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Prevention Rehabilitation

Keywords

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spine injuries brain lesions dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Videofluroscopic swallow study (VFSS)

To investigate the swallowing ability of patients with neurologic problems

Group Type ACTIVE_COMPARATOR

Videofluroscopic swallow study (VFSS)

Intervention Type PROCEDURE

Barium, radiation

cervical spine isometric excercises

isometric exercises in patients with cervical spine scoliosis

Group Type ACTIVE_COMPARATOR

cervical spine isometric exercises

Intervention Type PROCEDURE

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

Fiberoptic endoscopic esophageal study (FEES)

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

Group Type ACTIVE_COMPARATOR

Fiberoptic endoscopic esophageal study (FEES)

Intervention Type PROCEDURE

food for swallowing

Interventions

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Videofluroscopic swallow study (VFSS)

Barium, radiation

Intervention Type PROCEDURE

cervical spine isometric exercises

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

Intervention Type PROCEDURE

Fiberoptic endoscopic esophageal study (FEES)

food for swallowing

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* brain lesions and cervical spine disorders

Exclusion Criteria

* age
* peripheral damages
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Ioannina

Ioannina, , Greece

Site Status

Countries

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Greece

Other Identifiers

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85/2010

Identifier Type: -

Identifier Source: org_study_id