NCT06340009

Brief Summary

Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 25, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • House-Brackmann Scale (HBS)

    A widely used scale to assess facial nerve dysfunction.Grades facial muscle function from I (normal) to VI (total paralysis). - Higher scores indicate more severe dysfunction.

    week 6

  • Facial Disability Index (FDI)

    A patient-reported outcome measure assessing the impact of facial palsy on daily life.Assesses physical, social, and emotional functioning - Uses a questionnaire. - Higher scores indicate a greater impact on daily life.

    week 6

  • Sunnybrook Facial Grading System

    An assessment tool for evaluating facial muscle function, including static and dynamic aspects.

    week 6

  • Synkinesis Assessment Questionnaire (SAQ)

    An assessment tool specifically designed to evaluate synkinesis- related symptoms. Assesses the presence and severity of synkinesis symptoms during voluntary actions. - Uses a questionnaire. - Higher scores indicate more severe synkinesis-related symptoms.

    week 6

Study Arms (2)

Mime therapy group

EXPERIMENTAL

Mime therapy focuses on improving facial symmetry and muscle control through self-massage, breathing exercises, eye and lip closure exercises, letter and word exercises, and expression exercises in front of mirror

Other: mime therapy

motor imagery group

ACTIVE COMPARATOR

Motor imagery technique involves mental rehearsal of motor activities, activating similar brain regions as actual movements, which enhances neuroplasticity.

Other: motor imagery

Interventions

1. Facial Massage 2. Frowning 3. Close eyes 4. Smile 5. Fish Face 6. Eyebrow raising 7. Breathing exercise 8. Blow cheeks 9. Mouth opening and closing. 10. Moving lips side to side 11. Blow a candle. 12. Nasal flaring 13. Chewing exercise 14. Rinse mouth 15. Speaking vowels 16. Fill mouth with water 17. Fill rubber balloon 18. Sucking water with straw

Mime therapy group

1. Raising your eyebrows 2. Showing angry face 3. Closing and opening eyes 4. Pouting 5. Blowing cheeks 6. Smiling 7. Nasal flaring 8. Blowing candle 9. Deviating lips side to side 10. Chewing something 11. Speaking vowels

motor imagery group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-40 years
  • Both male and female
  • Patients diagnosed with Bell's Palsy
  • Paralysis/paresis of all muscle groups of one side of face

You may not qualify if:

  • Patients diagnosed with facial palsy
  • Patients with impaired cognition
  • Patients diagnosed with other neurological diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muzaffar Hospital

Sargodha, Pakistan

RECRUITING

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Ayesha Afridi, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mulazam Imran, MS-NMPT*

CONTACT

Ayesha Afridi, PhD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

March 22, 2024

Primary Completion

August 22, 2024

Study Completion

August 25, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations