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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01418105 |
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Date of registration:
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28/07/2011 |
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Primary sponsor: |
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Public title:
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Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
DysphagCerv |
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Scientific title:
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Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01418105 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
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Countries of recruitment
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Greece
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Contacts
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Name:
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Soultana Papadopoulou, SLT |
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Address:
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Telephone:
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Email:
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soultpap@yahoo.gr |
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Affiliation:
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Name:
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Soultana Papadopoulou |
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Address:
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Telephone:
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Email:
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soultpap@yahoo.gr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- brain lesions and cervical spine disorders
Exclusion Criteria:
- age
- peripheral damages
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prevention
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Rehabilitation
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Intervention(s)
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Procedure: cervical spine isometric exercises
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Procedure: Fiberoptic endoscopic esophageal study (FEES)
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Procedure: Videofluroscopic swallow study (VFSS)
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Primary Outcome(s)
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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]
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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]
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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]
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Secondary Outcome(s)
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change of cervical oswestry disability index
[Time Frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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