NCT06029855

Brief Summary

Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

March 28, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

September 1, 2023

Last Update Submit

March 27, 2025

Conditions

Keywords

Bell PalsyKabat RehabilitationMime Therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Synkinesis

    Synkinesis will be accessed through the "House-Brackmann Scale". It is classified as a universal scale. This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.

    It will be assessed at baseline, at the third week and at six week.

  • Level of Facial Disability

    The level of Facial disability will be measured through the "Facial Disability Index Scale". This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration). It uses a hundred-point scale with a higher score indicating less impairment. 24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.

    Change in functional status will be measured at the baseline, at 3rd week and at 6th week.

Study Arms (2)

Kabat Therapy

ACTIVE COMPARATOR

Kabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance. After 6th week, resting and voluntary symmetries were recorded.

Other: Kabat Therapy

Mime Therapy

EXPERIMENTAL

Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.

Other: Mime Therapy

Interventions

The participants of group A will receive Kabat Rehabilitation with routine physical therapy. The protocol will be given to the participants for three sessions/week for six weeks. Each session will be of 30 minutes.

Kabat Therapy

The participants of group B will receive Mime Therapy in addition to routine physical therapy. The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days. Each session will be of 30 minutes.

Mime Therapy

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group 25-50 years.
  • Both male and female.
  • Unilateral bell's paralysis.
  • Not congenital in origin.
  • Sub-acute and chronic cases.

You may not qualify if:

  • Other neurological deficits include epilepsy and Alzheimer's disease.
  • Traumatic onset.
  • Surgical reconstruction (nerve or muscle reconstruction).
  • Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
  • Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
  • Any contraindications for massage like sunburn, bruising, or cuts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (1)

  • Amjad A, Jamil A, Fatima N, Javaid HB, Zahid H. Effects of Kabat rehabilitation versus mime therapy on facial disability and synkinesis in patients of Bell's palsy. J Pak Med Assoc. 2024 Nov;74(11):1927-1931. doi: 10.47391/JPMA.11247.

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ashfaq Dr Ahmed, PhD

    University of Lahore

    STUDY CHAIR

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

September 1, 2023

First Posted

September 8, 2023

Study Start

May 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 15, 2023

Last Updated

March 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
Immediately after publication

Locations