NCT06083389

Brief Summary

To evaluate the comparative effectiveness of the Kabat rehabilitation technique with conventional physical therapy along with electrical stimulation in both, for reducing facial disability in patients with Bell's palsy. To assess the prognosis of patients with Bell's palsy, using the assay of serum level of ischemia-modified albumin, high-frequency ultrasonography (HFUS), and electrophysiological studies of the facial nerve.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Status
unknown

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

March 23, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

March 23, 2023

Last Update Submit

October 11, 2023

Conditions

Bell's Palsy

Keywords

rehabilitation facial palsy

Outcome Measures

Primary Outcomes (1)

  • facial nerve ultrasonography

    Thickness of facial nerve measured at the thickest part (measured by millimeters)

    at baseline

Study Arms (2)

traditional technique of facial exercises along with electrical stimulation of facial muscles.

ACTIVE COMPARATOR

facial muscle exercise active exercises will be initiated, which is performed in front of a mirror in sitting position. The patient will be instructed for activities like blowing air in the mouth, nasal flaring, smiling, raising and frowning of the eyebrows, opening and closing of the eye, clenching of the teeth and holding straw in mouth, suck and blow out air, show as if blowing a balloon for 20 minutes each session, for 3 sessions/ week for 6 weeks.

Device: electrotherapy

Kabat technique arm along with stimulation of facial muscles.

ACTIVE COMPARATOR

During the Kabat rehabilitation session, the patients will perform specific diagonal and spiral movements, involving the following three muscle fulcrums: * Upper fulcrum: includes the frontalis, corrugator \& orbicularis oculi muscles. * Intermediate fulcrum: includes the common elevator muscle of the upper lip and nasalis. * Lower fulcrum: includes the risorius, zygomaticus major, the orbicularis oris and buccinator. (Khanzada et al., 2018). The manipulation of these three fulcra will be carried out by utilizing contralateral contraction and the basic proprioceptive stimulation comprising stretching, maximal resistance, manual contact and verbal input. Kabat sessions will be 3 sessions / week for 6 weeks.

Behavioral: kabat technique for rehabilitation of facial palsyDevice: electrotherapy

Interventions

kabat technique for rehabilitation of facial palsyBEHAVIORAL

To evaluate the comparative effectiveness of the Kabat rehabilitation technique with conventional physical therapy along with electrical stimulation in both, for reducing facial disability in patients with Bell's palsy.

Kabat technique arm along with stimulation of facial muscles.
electrotherapyDEVICE

electrical stimulation of facial nerve supplied muscles.3 sessions per week.

Kabat technique arm along with stimulation of facial muscles.traditional technique of facial exercises along with electrical stimulation of facial muscles.

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis acute unilateral Bell's palsy.

You may not qualify if:

  • Any concurrent acute ischemia either cardiovascular or cerebrovascular disease.
  • Diabetic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.

    PMID: 27734980BACKGROUND

MeSH Terms

Conditions

Bell Palsy

Interventions

Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Aya Hassan Elmahdy

CONTACT

+201015722101d_ayaelmahdy@yahoo.com

Shereen Refaat Kamel

CONTACT

+201065800025sh_rr70@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer at faculty of medicine Minia university

Study Record Dates

First Submitted

March 23, 2023

First Posted

October 16, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

October 16, 2023

Record last verified: 2023-10