Facial Paralysis, CentralNCT06615297
Mimic Muscle Volume, Central Facial Palsy Severity and Dysphagia
An observational study of Facial Paralysis, Central and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
Trial summary
70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralysis, Central, Stroke
- What is being tested?
- ultrasonographic evaluation
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included
Who may be able to join
- Diagnosis of stroke and presence of unilateral central facial paralysis,
- Agreeing to participate in the study,
- Cognitive competence to understand the test instructions,
- Presence of communication skills to respond to the test instructions.
Who cannot join
- Presence of previous facial paralysis or a neurological disease other than stroke that will cause central paralysis,
- bilateral involvement
- illiteracy, refusal to participate in the study,
- jaw joint problem,
- surgical intervention in the facial area that will affect ultrasound measurements,
- infected open wound.
About this study
Official title: Demonstration of the Relationship Between Mimic Muscle Volume and Central Facial Palsy Severity and Dysphagia
70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.
Read the detailed description
70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included and their demographic data such as age, gender, marital status, education level, body mass index, stroke etiologies will be questioned and used with the House-Brackmann scale. Involvement levels, facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. The data obtained will be correlated with total dysphagia score and facial disability index.
- Conditions
- Facial Paralysis, Central, Stroke
- Being tested
- ultrasonographic evaluation
- Medical subject headings
- Facial Paralysis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic evaluationDiagnostic test
facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| central facial paralysis | 70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included Receives: Diagnostic Test: ultrasonographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial nerve thickness
the thickness of the nerve will be measured by ultrasound
Measured: baseline
Secondary outcomes (2)
depressor labi inferior
the thickness of the muscle will be measured by ultrasound
Measured: baseline
depressor anguli oris
the thickness of the muscle will be measured by ultrasound
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Paralysis, CentralStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615297
- Sponsor's protocol ID
- 2024-40
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration of the Relationship Between Mimic Muscle Volume and Central Facial Palsy Severity and Dysphagia
- ClinicalTrials.gov ID
- NCT06615297
- Acronym / sponsor ID
- 2024-40
- Conditions
- Facial Paralysis, Central, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.
Detailed description
70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included and their demographic data such as age, gender, marital status, education level, body mass index, stroke etiologies will be questioned and used with the House-Brackmann scale. Involvement levels, facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. The data obtained will be correlated with total dysphagia score and facial disability index.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| central facial paralysis | – | Diagnostic Test: ultrasonographic evaluation70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included
Key inclusion criteria (4 listed)
- Diagnosis of stroke and presence of unilateral central facial paralysis,
- Agreeing to participate in the study,
- Cognitive competence to understand the test instructions,
- Presence of communication skills to respond to the test instructions.
Key exclusion criteria (6 listed)
- Presence of previous facial paralysis or a neurological disease other than stroke that will cause central paralysis,
- bilateral involvement
- illiteracy, refusal to participate in the study,
- jaw joint problem,
- surgical intervention in the facial area that will affect ultrasound measurements,
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 |
|---|---|---|
| ultrasonographic evaluationfacial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. | Diagnostic test | central facial paralysis |
Primary outcome
facial nerve thickness
Time frame: baseline
the thickness of the nerve will be measured by ultrasound
2 secondary outcomes
depressor labi inferior
Time frame: baseline
depressor anguli oris
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Facial Paralysis, Central and Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
facial nerve thickness (time frame: baseline). 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 Sep 2024.