PreventionPhase 1DysphagCervNCT01418105
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions
A Phase 1 study testing Videofluroscopic swallow study (VFSS), cervical spine isometric exercises and Fiberoptic endoscopic esophageal study (FEES) in people with Prevention and Rehabilitation, run by University of Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention, Rehabilitation
- What is being tested?
- Videofluroscopic swallow study (VFSS), cervical spine isometric exercises and Fiberoptic endoscopic esophageal study (FEES)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2011to Oct 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- brain lesions and cervical spine disorders
Who cannot join
- age
- peripheral damages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
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
- Being tested
- Videofluroscopic swallow study (VFSS), cervical spine isometric exercises, Fiberoptic endoscopic esophageal study (FEES)
- Keywords
- spine injuries, brain lesions, dysphagia
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluroscopic swallow study (VFSS)Procedure or surgery
Barium, radiation
cervical spine isometric exercisesProcedure or surgery
patients with cervical scoliosis will execute isometric exercises of the cervical spine
Fiberoptic endoscopic esophageal study (FEES)Procedure or surgery
food for swallowing
| Study group | Role | What they receive |
|---|---|---|
| Videofluroscopic swallow study (VFSS) | Active comparator | To investigate the swallowing ability of patients with neurologic problems Receives: Procedure: Videofluroscopic swallow study (VFSS) |
| cervical spine isometric excercises | Active comparator | isometric exercises in patients with cervical spine scoliosis Receives: Procedure: cervical spine isometric exercises |
| Fiberoptic endoscopic esophageal study (FEES) | Active comparator | To investigate the anatomic structures during swallowing of patients with neurologic problems Receives: Procedure: Fiberoptic endoscopic esophageal study (FEES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in swallowing ability and quality of life by swal-quol questionnaire
Measured: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
change of swallowing ability by Okuma's questionnaire
Measured: 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
Measured: 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
this questionnaire will be distributed only to patients with previous cervical spine problems
Measured: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraam Ploumis, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418105
- Sponsor's protocol ID
- 85/2010
- Acronym
- DysphagCerv
- Status last verified
- Oct 2016
- First submitted
- 28 Jul 2011
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia and Cervical Spine Disorders in Patients With Neurologic Deficits Due to Brain Lesions
- ClinicalTrials.gov ID
- NCT01418105
- Acronym / sponsor ID
- DysphagCerv / 85/2010
- Conditions
- Prevention, Rehabilitation
- Keywords
- spine injuries, brain lesions, dysphagia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Videofluroscopic swallow study (VFSS) | Active comparator | Procedure: Videofluroscopic swallow study (VFSS)To investigate the swallowing ability of patients with neurologic problems |
| cervical spine isometric excercises | Active comparator | Procedure: cervical spine isometric exercisesisometric exercises in patients with cervical spine scoliosis |
| Fiberoptic endoscopic esophageal study (FEES) | Active comparator | Procedure: Fiberoptic endoscopic esophageal study (FEES)To investigate the anatomic structures during swallowing of patients with neurologic problems |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- brain lesions and cervical spine disorders
Key exclusion criteria (2 listed)
- age
- peripheral damages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videofluroscopic swallow study (VFSS)Barium, radiation | Procedure or surgery | Videofluroscopic swallow study (VFSS) |
| cervical spine isometric exercisespatients with cervical scoliosis will execute isometric exercises of the cervical spine | Procedure or surgery | cervical spine isometric excercises |
| Fiberoptic endoscopic esophageal study (FEES)food for swallowing | Procedure or surgery | Fiberoptic endoscopic esophageal study (FEES) |
Primary outcome
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
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
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
1 secondary outcome
change of cervical oswestry disability index
Time frame: at the time of admittance to the rehabilitation department (baseline), at six weeks, at one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Videofluroscopic swallow study (VFSS), cervical spine isometric exercises and Fiberoptic endoscopic esophageal study (FEES) in people with Prevention and Rehabilitation, run by University of Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.