Outcome of Facial Palsy Following Rehabilitation | NCT04215562

Studies
Outcome of Facial Palsy Following Rehabilitation

NCT04215562

Sponsor

University of Alexandria

Status

Unknown status

Last Update Posted

May 26, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Facial Paralysis

Interventions

rehabilitation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Mar 1, 2023Estimated

First Submitted Date

Dec 29, 2019

First Submission Date that Met QC Criteria

Dec 29, 2019

First Posted Date

Jan 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2022

Last Update Posted Date

May 26, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yousra Hisham Abdel Fattah, Lecturer of Physical Medicine, Rheumatology and Rehabilitation, University of AlexandriaPrincipal Investigator

Lead Sponsor

University of AlexandriaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Retrospective case series,the aim of this study is to assess the outcome and rate of complications in patients with facial palsy following rehabilitation, a retrospective study.

Detailed Description

Data from all patients presenting to the outpatient clinics of the Physical Medicine, Rheumatology and Rehabilitation Department. Faculty of Medicine, Alexandria University in the past 3 years will be collected. The outcome and complications from rehabilitation of facial palsy will be recorded.

Primary Outcome: complications of Facial palsy following rehabilitation. Confidentiality of all records will be ensured.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients with peripheral facial palsy	Other	collection of data from records on the outcome of rehabilitation therapy on patients with peripheral facial palsy and types of complications associated with this therapy type	Combination Product: rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rehabilitation	Combination Product	electro-therapy, heat therapy, massage and exercise therapy	patients with peripheral facial palsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prognosis or outcome of therapy	have patients recovered fully, partially or did not recover	3-6 months
complications	types of complications developed during rehabilitation	3-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients with primary idiopathic peripheral facial palsy

Exclusion Criteria:

all patients with secondary causes of facial palsy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yousra Hisham A Fattah	Alexandria University Faculty of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University, Faculty of Medicine		Alexandria		00123	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005158	Facial Paralysis

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010243	Paralysis
D009461	Neurologic Manifestations

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided