Peripheral Facial ParalysisMATPFNCT03284125
Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis
An observational study of Peripheral Facial Paralysis, run by University Hospital, Tours at 1 site in France.
Trial summary
The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Peripheral Facial Paralysis
- What is being tested?
- Swallowing disorders evaluation
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2017to 12 Jun 2018
- Phase
- Observational
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients affected by facial paralysis and treated by lenthening temporalis myoplasty
Who may be able to join
- Chronic peripheral facial paralysis
- Freyss score inferior at 15
- Benefiting of a lengthening temporalis myoplasty
Who cannot join
- Malformative syndrome
- Other swallowing trouble
- Psychiatric trouble
- Opposed at this study
Trial locations and contacts
1 site in 1 country.
About this study
The facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.
This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .
- Conditions
- Peripheral Facial Paralysis
- Being tested
- Swallowing disorders evaluation
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing disorders evaluationOther
Self-administered questionnaires and non-invasive clinics tests
| Study group | Role | What they receive |
|---|---|---|
| Facial paralysis | Patients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery. Receives: Other: Swallowing disorders evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline lips pressure at 6 months
Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after
Measured: Baseline, 3 and 6 months
Secondary outcomes (3)
Drooling Severity and Frequency Scale (DSFS)
The Drooling Score equals the sum of the Severity and Frequency sub-scores. the severity sub scores contains five items ( 1= never, 2= mild drooling, 3= moderate drool, 4= severe drool, 5= profuse drool) The frequency sub score contains four items ( 1= no drooling, 2= occasionally, 3=frequently, 4= constant drooling)
Measured: Baseline, 3 and 6 months
Visual scale of food residue
Patients must eat a melba toast on paretic side and after we evaluate the food residue before surgery and at 3 and 6 months after
Measured: Baseline, 3 and 6 months
Dysphagia handicap index (DHI)
This self-administered questionnaire allows to evaluate 3 types of handicap (physical, functional and social) It contains 30 questions and the maximum score is 120 (0= never, 1= almost never, 2= occasionally, 3= almost always, 4= always)
Measured: Baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start2 Sep 2017
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Facial ParalysisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris LAURE, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284125
- Sponsor's protocol ID
- RIPH3-RNI17/MATPF
- Other IDs
- 2017-A01577-46, 2017-39
- Acronym
- MATPF
- Status last verified
- Apr 2021
- First submitted
- 6 Sep 2017
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lengthening Temporalis Myoplasty and Improvement of Primary Swallowing Disorders in Facial Paralysis
- ClinicalTrials.gov ID
- NCT03284125
- Acronym / sponsor ID
- MATPF / RIPH3-RNI17/MATPF
- Conditions
- Peripheral Facial Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 15 Sep 2017 (actual)
- 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 facial paralysis is a frequent disease causing important functionals swallowing dysfunctions. The purpose of our study was to evaluate the improvement of the swallowing disorders after surgery by lengthening temporalis myoplasty (LTM) in the facial paralysis.
This prospective study has realised on the following of patients affected by facial paralysis treated by LTM. Self-administered questionnaires and clinics tests had realized to analyze three components oh the oral phase of the swallowing ( drooling, mastication and handicap). The evaluations was realized before the surgery and at 3 and 6 months after .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial paralysis | – | Other: Swallowing disorders evaluationPatients affected by facial paralysis treated by LTM The aim is to evaluate the improvement of the swallowing disorders after surgery. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients affected by facial paralysis and treated by lenthening temporalis myoplasty
Key inclusion criteria (3 listed)
- Chronic peripheral facial paralysis
- Freyss score inferior at 15
- Benefiting of a lengthening temporalis myoplasty
Key exclusion criteria (4 listed)
- Malformative syndrome
- Other swallowing trouble
- Psychiatric trouble
- Opposed at this study
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 |
|---|---|---|
| Swallowing disorders evaluationSelf-administered questionnaires and non-invasive clinics tests | Other | Facial paralysis |
Primary outcome
Change from baseline lips pressure at 6 months
Time frame: Baseline, 3 and 6 months
Patients must contracted their lips of the paretic side in a manometer to evaluate the pressure of the lips before surgery and at 3 and 6 months after
3 secondary outcomes
Drooling Severity and Frequency Scale (DSFS)
Time frame: Baseline, 3 and 6 months
Visual scale of food residue
Time frame: Baseline, 3 and 6 months
Dysphagia handicap index (DHI)
Time frame: Baseline, 3 and 6 months
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 28 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Boris LAURE, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Facial Paralysis, run by University Hospital, Tours at 1 site in France.
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 3 inclusion and 4 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 28 Apr 2021. 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 France. 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.
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 from baseline lips pressure at 6 months (time frame: Baseline, 3 and 6 months). 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 28 Apr 2021.