NCT04993417

Brief Summary

This project was a Randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. Duration was of 6 months, convenient sampling was done, subjects following eligibility criteria from Imran Idrees Teaching hospital and Idrees Hospital Sialkot, were randomly allocated in two groups via computer generated method, baseline assessment was done, MIT Group received motor imagery technique, 45 min session (3 times a week for 3 months) plus the EMS (10-15 min), while the MT Group received mime therapy 30-45 min session (3 times a week for 3 months) plus the EMS (10-15 min). Outcome measures were collected for both groups at before treatment (T0) and at the end of the treatment i-e after 3 months (T1). The outcome measures were severity of paresis, facial symmetry and intensity of depression measured by using House-Brackmann Scale, Sunnybrook Facial Grading System and Beck Depression Inventory Scale, respectively. Data was analyzed by using SPSS version 24.0.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

July 19, 2021

Last Update Submit

August 5, 2021

Conditions

Keywords

Facial nerve palsyMime therapyMotor imagery technique

Outcome Measures

Primary Outcomes (1)

  • House-Brackmann Scale (HBS)

    House-Brackmann Facial Grading System comprises of six evaluations, where grade 1 addresses normal function and grade VI addresses complete loss of motion. It is quite possibly the most generally utilized scales and has been appeared to have great between rater reliability anyway its affectability to change in facial symmetry is low.

    12th Week

Secondary Outcomes (1)

  • Sunnybrook Facial Grading System (SFGS)

    12 Week

Other Outcomes (1)

  • Beck Depression Inventory Scale (BDI)

    12 Week

Study Arms (2)

Mime Therapy along with EMS

EXPERIMENTAL

MT Group: Mime Therapy along with EMS

Other: Mime Therapy along with EMS

Motor imagery technique along with EMS

EXPERIMENTAL

MIT Group: Motor imagery technique along with EMS

Other: Motor imagery technique along with EMS

Interventions

All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. The patients were mentioned to play out the emotional facial appearances for non-verbal correspondence i-e pleasure, misery, interest, appall, dread, irritation and shock. Patients were then requestedto envision himself winking, for instance, envisioning himself in a wonderful and natural social setting, at that point the patient cognitively addresses, with his eyes shut, the movement of decaying the recognized central issues, without creating any specific movement.

Motor imagery technique along with EMS

All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. Mime treatment incorporates self kneading of face and neck, breathing and relaxation works out, activities to synchronize the two sides and diminish synkinesis and for eye and lip closure per the myofascial way to deal with recovery, letter and word practices and expressive activities.

Mime Therapy along with EMS

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral facial palsy more than 6 months
  • Age 20-60 years
  • House-Brackmann Scale Score ≥3
  • Both genders

You may not qualify if:

  • Pregnant women
  • Psychological treatment for any psychiatric disorder
  • Participants with the history of any tumor
  • Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Idrees Teaching Hospital

Sialkot, Punjab Province, Pakistan

Location

Related Publications (12)

  • Garro A, Nigrovic LE. Managing Peripheral Facial Palsy. Ann Emerg Med. 2018 May;71(5):618-624. doi: 10.1016/j.annemergmed.2017.08.039. Epub 2017 Oct 27. No abstract available.

    PMID: 29110887BACKGROUND
  • Robinson MW, Baiungo J. Facial Rehabilitation: Evaluation and Treatment Strategies for the Patient with Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1151-1167. doi: 10.1016/j.otc.2018.07.011. Epub 2018 Sep 24.

    PMID: 30262166BACKGROUND
  • Codari M, Pucciarelli V, Stangoni F, Zago M, Tarabbia F, Biglioli F, Sforza C. Facial thirds-based evaluation of facial asymmetry using stereophotogrammetric devices: Application to facial palsy subjects. J Craniomaxillofac Surg. 2017 Jan;45(1):76-81. doi: 10.1016/j.jcms.2016.11.003. Epub 2016 Nov 17.

    PMID: 27939040BACKGROUND
  • Dusseldorp JR, van Veen MM, Mohan S, Hadlock TA. Outcome Tracking in Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1033-1050. doi: 10.1016/j.otc.2018.07.003. Epub 2018 Aug 29.

    PMID: 30172554BACKGROUND
  • Greene JJ, Guarin DL, Tavares J, Fortier E, Robinson M, Dusseldorp J, Quatela O, Jowett N, Hadlock T. The spectrum of facial palsy: The MEEI facial palsy photo and video standard set. Laryngoscope. 2020 Jan;130(1):32-37. doi: 10.1002/lary.27986. Epub 2019 Apr 25.

    PMID: 31021433BACKGROUND
  • Monsanto RD, Bittencourt AG, Bobato Neto NJ, Beilke SC, Lorenzetti FT, Salomone R. Treatment and Prognosis of Facial Palsy on Ramsay Hunt Syndrome: Results Based on a Review of the Literature. Int Arch Otorhinolaryngol. 2016 Oct;20(4):394-400. doi: 10.1055/s-0036-1584267. Epub 2016 May 30.

    PMID: 27746846BACKGROUND
  • Joseph SS, Joseph AW, Smith JI, Niziol LM, Musch DC, Nelson CC. Evaluation of Patients with Facial Palsy and Ophthalmic Sequelae: A 23-Year Retrospective Review. Ophthalmic Epidemiol. 2017 Oct;24(5):341-345. doi: 10.1080/09286586.2017.1294186. Epub 2017 Mar 20.

    PMID: 28319442BACKGROUND
  • Faris C, Tessler O, Heiser A, Hadlock T, Jowett N. Evaluation of Societal Health Utility of Facial Palsy and Facial Reanimation. JAMA Facial Plast Surg. 2018 Dec 1;20(6):480-487. doi: 10.1001/jamafacial.2018.0866.

    PMID: 30178066BACKGROUND
  • D'Souza AF, Rebello SRJIJoT, Rehabilitation. Comparing the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in acute Bell's palsy: a pilot randomised clinical trial. 2021;28(3):1-8.

    BACKGROUND
  • Park Y-K, Lee CI, Lee JH, Lee H-J, Lee Y-k, Seo J-C, et al. A Facial Chuna Manual Therapy for Peripheral Facial Nerve Palsy. 2019;36(4):197-203

    BACKGROUND
  • Markey JD, Loyo M. Latest advances in the management of facial synkinesis. Curr Opin Otolaryngol Head Neck Surg. 2017 Aug;25(4):265-272. doi: 10.1097/MOO.0000000000000376.

    PMID: 28604403BACKGROUND
  • Jo YK, Lee YJ, Jeon JH, Kim YIJJoHM. Review on Clinical Studies of Facial Palsy Sequelae Treatment. 2019;28(1):1-12.

    BACKGROUND

MeSH Terms

Conditions

Facial ParalysisBell Palsy

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsFacial Nerve DiseasesCranial Nerve Diseases

Study Officials

  • Mehwish Ikram, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

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

July 19, 2021

First Posted

August 6, 2021

Study Start

November 30, 2020

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations