NCT06028191

Brief Summary

The objective of this current study is to determine the combined effects of Low-Level Laser Therapy (LLLT) and the Kabat technique on quality of life, synkinetic movements and functional outcome in patients of Bell's palsy

Trial Health

43
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 Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 17, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 8, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 31, 2023

Last Update Submit

August 31, 2023

Conditions

Keywords

Bell's PalsyFacial Disability IndexKabat TechniqueLow Level Laser TherapySunnybrook facial grading system

Outcome Measures

Primary Outcomes (1)

  • Sunnybrook Facial Grading system

    Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles

    6 weeks

Secondary Outcomes (1)

  • Facial disability index

    6 weeks

Study Arms (2)

Kabat Technique along with baseline treatment

OTHER

Kabat technique will be performed for 15 min along with baseline treatment will be given to Group A. They will have 45 min-1 hour session thrice a week in duration of six weeks.

Other: Kabat Technique along with baseline treatment

Kabat Technique and LLLT along with baseline treatment

EXPERIMENTAL

Kabat technique will be performed for 15 min and LLLT will be performed for 10 min to eight points of the effected side for 2 min at each point along with baseline treatment. They will have 45 min-1 hour session thrice a week in duration of six weeks

Device: Kabat Technique and LLLT along with baseline treatment

Interventions

Group A will receive Kabat Technique along with baseline treatment. Electrical muscle stimulation for 15 min which includes faradic current to the facial nerve trunks given by DL-2 electro pulse stimulator, Effleurage and Kneading for 5 min and resistive exercise for 5 min and facial expression exercises for 5 min, which included eye closure, eyebrow raise, frown, smile, snarl, pucker and pout as baseline treatment. Kabat Technique is neurorehabilitation technique that uses diagonal and spiralpatterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator

Also known as: Group A
Kabat Technique along with baseline treatment

Group B will receive Kabat Technique and LLLT along with baselinetreatment. Kabat technique is same as mentioned in group A. Laser treatment will be administered to eight points of the affected side for 2 min at each point at a wavelength of 830 nm, output power of 100 Mw, and frequency of 1 KHz. Endo laser 422 is the model name and number of device which will be used in this study to administered low level laser therapy.

Also known as: Group B
Kabat Technique and LLLT along with baseline treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40
  • Both genders will be included
  • Unilateral Facial paralysis/paresis
  • Patients presented within onset of 12 days - 3 weeks (sub-acute Bell's Palsy)

You may not qualify if:

  • Previous surgery of facial reconstruction
  • Traumatic Brain Injury
  • Any other neurological deficit
  • Congenital Deformities
  • Recurrent Bell's palsy will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Allied Hospital

Faisalābad, Punjab Province, 38000, Pakistan

RECRUITING

Physiofit

Faisalābad, Punjab Province, 38000, 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

  • Fatima Tariq, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatima Tariq, Mphil

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

August 31, 2023

First Posted

September 8, 2023

Study Start

July 17, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

September 8, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations