Back to resultsDysphagia and Cervical Spine Disorders in Patients With Brain Lesions (DysphagCerv)
Primary Purpose
Prevention, Rehabilitation
Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Videofluroscopic swallow study (VFSS)
cervical spine isometric exercises
Fiberoptic endoscopic esophageal study (FEES)
Sponsored by
About this trial
This is an interventional health services research trial for Prevention focused on measuring spine injuries, brain lesions, dysphagia
Eligibility Criteria
Inclusion Criteria:
- brain lesions and cervical spine disorders
Exclusion Criteria:
- age
- peripheral damages
Sites / Locations
- University Hospital of Ioannina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Videofluroscopic swallow study (VFSS)
cervical spine isometric excercises
Fiberoptic endoscopic esophageal study (FEES)
Arm Description
To investigate the swallowing ability of patients with neurologic problems
isometric exercises in patients with cervical spine scoliosis
To investigate the anatomic structures during swallowing of patients with neurologic problems
Outcomes
Primary Outcome Measures
change in swallowing ability and quality of life by swal-quol questionnaire
change of swallowing ability by Okuma's questionnaire
change of cervical scoliosis measured by Cobb method in x-rays
Secondary Outcome Measures
change of cervical oswestry disability index
this questionnaire will be distributed only to patients with previous cervical spine problems
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01418105
Brief Title
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
Acronym
DysphagCerv
Official Title
Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention, Rehabilitation
Keywords
spine injuries, brain lesions, dysphagia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Videofluroscopic swallow study (VFSS)
Arm Type
Active Comparator
Arm Description
To investigate the swallowing ability of patients with neurologic problems
Arm Title
cervical spine isometric excercises
Arm Type
Active Comparator
Arm Description
isometric exercises in patients with cervical spine scoliosis
Arm Title
Fiberoptic endoscopic esophageal study (FEES)
Arm Type
Active Comparator
Arm Description
To investigate the anatomic structures during swallowing of patients with neurologic problems
Intervention Type
Procedure
Intervention Name(s)
Videofluroscopic swallow study (VFSS)
Intervention Description
Barium, radiation
Intervention Type
Procedure
Intervention Name(s)
cervical spine isometric exercises
Intervention Description
patients with cervical scoliosis will execute isometric exercises of the cervical spine
Intervention Type
Procedure
Intervention Name(s)
Fiberoptic endoscopic esophageal study (FEES)
Intervention Description
food for swallowing
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
change of cervical oswestry disability index
Description
this questionnaire will be distributed only to patients with previous cervical spine problems
Time Frame
at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
brain lesions and cervical spine disorders
Exclusion Criteria:
age
peripheral damages
Facility Information:
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
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