- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06615297
Mimic Muscle Volume, Central Facial Palsy Severity and Dysphagia
September 24, 2024 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
70
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
facial nerve thickness
Time Frame: baseline
|
the thickness of the nerve will be measured by ultrasound
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
depressor labi inferior
Time Frame: baseline
|
the thickness of the muscle will be measured by ultrasound
|
baseline
|
|
depressor anguli oris
Time Frame: baseline
|
the thickness of the muscle will be measured by ultrasound
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
September 13, 2024
First Submitted That Met QC Criteria
September 24, 2024
First Posted (Actual)
September 26, 2024
Study Record Updates
Last Update Posted (Actual)
September 26, 2024
Last Update Submitted That Met QC Criteria
September 24, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.