Effectiveness of ES and MT VS ES and PNF Technique Among... | NCT05855928

Studies
Effectiveness of ES and MT VS ES and PNF Technique Among Bells Palsy Patients

NCT05855928

Sponsor

Superior University

Status

Unknown status

Last Update Posted

May 12, 2023Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Bell Palsy

Interventions

Mime Therapy
PNF Technique

Countries

Pakistan

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Mar 18, 2023

First Submission Date that Met QC Criteria

May 2, 2023

First Posted Date

May 12, 2023Actual

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 2, 2023

Last Update Posted Date

May 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength & restoring lost motor function in the patients of Bell's palsy

Detailed Description

Not provided

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

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electrical Stimulation and Mime Therapy	Other		Diagnostic Test: Mime Therapy
Electrical Stimulation and PNF Technique	Experimental		Diagnostic Test: PNF Technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mime Therapy	Diagnostic Test	electrical stimulation with the MIME therapy and protocol	Electrical Stimulation and Mime Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Facial disability index(FDI) Scale	Physical function, Difficulties	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Acute, unilateral, lower motor neuron bells palsy patient with house-backmann scale 4
- Acute onset 1-3 weeks
- Age group 20-40 years
- Who were are willing to be a part of the study
- Patients with the Bell's palsy (Facial paralysis , idiopathic facial paralysis and the herpetic facial paralysis)

Exclusion Criteria:

• Patient who had the autoimmune disorder, tumors, recent head injury
- The subject long with the surgery for ear and the fascial nerve palsy
- Metal dental implants, and pregnant women
- The patient with any peripheral vascular diseases
- Central fascial palsy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Javeria khalid, DPT	Contact	+923074464878		javeriakhalid14@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Superior University CRC	Recruiting	Lahore	Punjab Province		Pakistan

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
D020330	Bell Palsy

Ancestor Terms

ID	Term
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided