NCT04936152

Brief Summary

The objective of this study is to compare the effects of mime therapy using mirror therapy application of tablet PC vs mime therapy on acute bell's palsy. Study Design was Randomized control trial with Sample Size was 22. Sampling Technique was Purposive sampling. Randomization was done through a sealed envelope method. Study Setting included Physiotherapy department of DHQ Teaching Hospital, Mirpur Azad Kashmir. Inclusion criteria were Age between 30-60year, Both male \& female and Acute bell's palsy ( 2-3 weeks). Exclusion criteria were Individuals with the other neurological deficits, Visual impairment, History of facial palsy of central type, Surgical intervention for ear and facial nerve palsy and Non-co-operative patients. tools used for assessment was Sunnybrook Facial Grading system scale, House-Brackmann Facial Grading System and Patients Global Impression of Change. Individuals who met the inclusion criteria were included in this study. All participants went through randomization and divided into two groups Experimental group 1 (these individuals will receive mime therapy using tablet PC mirror application)and Experimental group 2 (these individuals will receive the control intervention including the mime therapy). Pre-intervention assessment is made for both groups. Then intervention will apply to both groups. Estimated time of treatment protocol will be 30 minutes session, 4 times/week for 4 weeks in the hospital setting. Subjects will be evaluated at baseline, then 2nd week and 4th-week assessment will be the final. All statistical analyses were performed through SPSS 21. Normality of data was assessed and after checking normality parametric or non-parametric test was applied accordingly. .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 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

August 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 21, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

3 months

First QC Date

December 21, 2020

Last Update Submit

August 12, 2021

Conditions

Keywords

Bell Palsymime therapymirror therapy

Outcome Measures

Primary Outcomes (1)

  • Sunnybrook Facial Grading system scale

    The Sunnybrook facial grading scale is a regionally weighted system that includes evaluation of resting symmetry, degree of voluntary movements and synkinesis to form a composite score from 0 to 100, where 0 is complete paralysis and 100 normal facial functions. The tool will be used for assessment.

    4 weeks

Other Outcomes (2)

  • House-Brackmann Facial Grading System

    4 weeks

  • Patients Global Impression of Change

    4 weeks

Study Arms (2)

mime therapy using tablet PC mirror application

ACTIVE COMPARATOR

these individuals will receive mime therapy using tablet PC mirror application

Other: mime therapy using tablet PC mirror application

the control intervention including the mime therapy

EXPERIMENTAL

these individuals will receive the control intervention including the mime therapy).

Other: the control intervention including the mime therapy

Interventions

After the baseline assessment, The patient in the experimental group will receive mirror therapy and mime therapy. Exercises time period is 30 min/session Mime Therapy Using Tablet PC: Mirror therapy using tablet PC mirror application We will use a tablet PC mirror application that can convert images from right to left. In the mirror group, the mirror application was used during the exercise. Patients watched the tablet PC screen. The mirror application converts the image from right to left. • Mime therapy include Mime therapy will consists of auto massage- effleurage and kneading for 10 to 15minutes on both the sides of the face, stretching exercises of the muscles of the affected side followed by facilitation, specific low intensity exercises to co-ordinate both the halves of the face, active assisted exercises for affected side of the face, exercises of mouth and eye with simultaneous inhibition of synkinesis if present.

mime therapy using tablet PC mirror application

After the baseline assessment, The patient in the experimental group will receive mime therapy Mime therapy include Mime therapy will consists of auto massage- effleurage and kneading for 10 to 15minutes on both the sides of the face, stretching exercises of the muscles of the affected side followed by facilitation, specific low intensity exercises to co-ordinate both the halves of the face, active assisted exercises for affected side of the face, exercises of mouth and eye with simultaneous inhibition of synkinesis if present.

the control intervention including the mime therapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Acute bell's palsy ( 2-3 weeks)

You may not qualify if:

  • Individuals with the other neurological deficits
  • Visual impairment
  • History of facial palsy of central type
  • Surgical intervention for ear and facial nerve palsy.
  • Non co-operative patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (12)

  • Cronin GW, Steenerson RL. The effectiveness of neuromuscular facial retraining combined with electromyography in facial paralysis rehabilitation. Otolaryngol Head Neck Surg. 2003 Apr;128(4):534-8. doi: 10.1016/S0194-59980300005-6.

    PMID: 12707657BACKGROUND
  • Santos MA, Caiaffa Filho HH, Vianna MF, Almeida AG, Lazarini PR. Varicella zoster virus in Bell's palsy: a prospective study. Braz J Otorhinolaryngol. 2010 May-Jun;76(3):370-3. doi: 10.1590/S1808-86942010000300016.

    PMID: 20658018BACKGROUND
  • Devriese PP. Rehabilitation of facial expression ("mime therapy"). Eur Arch Otorhinolaryngol. 1994 Dec:S42-3. No abstract available.

    PMID: 10774308BACKGROUND
  • Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.

    PMID: 24189771BACKGROUND
  • Beurskens CH, Heymans PG. Mime therapy improves facial symmetry in people with long-term facial nerve paresis: a randomised controlled trial. Aust J Physiother. 2006;52(3):177-83. doi: 10.1016/s0004-9514(06)70026-5.

    PMID: 16942452BACKGROUND
  • Finsterer J. Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 Jul;265(7):743-52. doi: 10.1007/s00405-008-0646-4. Epub 2008 Mar 27.

    PMID: 18368417BACKGROUND
  • Teixeira LJ, Soares BG, Vieira VP, Prado GF. Physical therapy for Bell s palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006283. doi: 10.1002/14651858.CD006283.pub2.

    PMID: 18646144BACKGROUND
  • Lee JM, Choi KH, Lim BW, Kim MW, Kim J. Half-mirror biofeedback exercise in combination with three botulinum toxin A injections for long-lasting treatment of facial sequelae after facial paralysis. J Plast Reconstr Aesthet Surg. 2015 Jan;68(1):71-8. doi: 10.1016/j.bjps.2014.08.067. Epub 2014 Sep 18.

    PMID: 25444667BACKGROUND
  • Azuma T, Nakamura K, Takahashi M, Ohyama S, Toda N, Iwasaki H, Kalubi B, Takeda N. Mirror biofeedback rehabilitation after administration of single-dose botulinum toxin for treatment of facial synkinesis. Otolaryngol Head Neck Surg. 2012 Jan;146(1):40-5. doi: 10.1177/0194599811424125. Epub 2011 Sep 30.

    PMID: 21965443BACKGROUND
  • Kang JA, Chun MH, Choi SJ, Chang MC, Yi YG. Effects of Mirror Therapy Using a Tablet PC on Central Facial Paresis in Stroke Patients. Ann Rehabil Med. 2017 Jun;41(3):347-353. doi: 10.5535/arm.2017.41.3.347. Epub 2017 Jun 29.

    PMID: 28758071BACKGROUND
  • Neely JG, Cherian NG, Dickerson CB, Nedzelski JM. Sunnybrook facial grading system: reliability and criteria for grading. Laryngoscope. 2010 May;120(5):1038-45. doi: 10.1002/lary.20868.

    PMID: 20422701BACKGROUND
  • Reitzen SD, Babb JS, Lalwani AK. Significance and reliability of the House-Brackmann grading system for regional facial nerve function. Otolaryngol Head Neck Surg. 2009 Feb;140(2):154-8. doi: 10.1016/j.otohns.2008.11.021.

    PMID: 19201280BACKGROUND

MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dr Aruba Saeed, PHD*

    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

December 21, 2020

First Posted

June 23, 2021

Study Start

August 15, 2020

Primary Completion

November 15, 2020

Study Completion

December 30, 2020

Last Updated

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations