NCT06615297

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

September 26, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 13, 2024

Last Update Submit

September 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • facial nerve thickness

    the thickness of the nerve will be measured by ultrasound

    baseline

Secondary Outcomes (2)

  • depressor labi inferior

    baseline

  • depressor anguli oris

    baseline

Study Arms (1)

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

Diagnostic Test: ultrasonographic evaluation

Interventions

facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.

central facial paralysis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Facial ParalysisStroke

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 26, 2024

Study Start

October 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

September 26, 2024

Record last verified: 2024-09