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Mirror Therapy on PC in Acute Bell's Palsy.

Primary Purpose

Bell Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
mime therapy using tablet PC mirror application
the control intervention including the mime therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Bell Palsy, mime therapy, mirror therapy

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Acute bell's palsy ( 2-3 weeks)

Exclusion Criteria:

  • 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.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

mime therapy using tablet PC mirror application

the control intervention including the mime therapy

Arm Description

these individuals will receive mime therapy using tablet PC mirror application

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2020
Last Updated
August 12, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04936152
Brief Title
Mirror Therapy on PC in Acute Bell's Palsy.
Official Title
Effects of Mirror Therapy Application of Tablet pc on Acute Bell's Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. .
Detailed Description
Damage or dysfunction of the facial nerve can result in paralysis, abnormal muscle tone, abnormal movement patterns, eye irritations, and decreased facial expression. Medical conditions that can typically result in facial nerve dysfunction are Bell's palsy, herpesvirus, temporal bone fracture, facial or head trauma, acoustic neuroma excision, facial nerve schwannoma, vascular damage, and neoplasms. The facial nerve sustains impairment more often than any other nerve in the body. The term Bells' Palsy is defined as an idiopathic, acute and unilateral paresis or paralysis of the face which may be partial or complete occurring with equal frequencies on right and left sides of the face. The major cause of Bell's Palsy is idiopathic, accounting for 50% of all cases. Other few suggested causes are exposure to cold, middle ear infections, dental and ENT surgeries and traumatic. The problems faced in the acute phase of Bell's palsy include difficulty in closing the affected side-eye, facial deviation to the unaffected side, difficulty in drinking, eating and speaking along with psychological problems and facial appearance is the main concern in any phase of Bell's palsy. Complete recovery of facial function in Bell's palsy occurs in 70% of people within three months (Peitersen 1994) with about 30% of people continuing to suffer facial asymmetry at rest and during movement, as well as synkinesis. Treatment of Bell's palsy is controversial due to the lack of large, randomized, controlled, prospective studies. There are indications that steroids or antiviral agents are beneficial but also studies, which show no beneficial effect. Additional measures include eye protection, physiotherapy, acupuncture, botulinum toxin, or possibly surgery. A Cochrane review done by in February 2011 has concluded that there is only very low-quality evidence that facial exercise reduces sequel in acute cases. A study done in 2009 has concluded that massage done in mime therapy has shown to create new growth and increase the production of collagen and connective tissue in facial muscles and restore facial muscle action. A study done on mime therapy efficacy in patients with long term facial nerve paresis shows that mime therapy improves facial symmetry.A study of 2014 observed the half-mirror biofeedback exercise in combination with three botulinum toxin after facial paralysis. Half-mirror biofeedback rehabilitation designed for facial sequelae shows good results in combination with botulinum toxin therapy. This facial rehabilitation strategy, consisting of three injections of botulinum toxin and half-mirror biofeedback exercises, proceeds over the course of 2 years and offers a long-lasting cure for facial synkinesis and facial symmetry as well as improved facial aesthetics. A study in 2011 on facial biofeedback rehabilitation with a mirror after administration of a single dose of botulinum A toxin on facial synkinesis was examined in patients with chronic facial palsy concluded that Facial biofeedback rehabilitation with a mirror after administration of a single dose of botulinum A toxin can be a long-lasting treatment of established facial synkinesis. A study of, 2013 Mime therapy improves facial symmetry and functions more than conventional therapy and home exercises in people with acute Bell's Palsy. No difference was found between conventional therapy and home exercise program. A study in, 2016 investigate the effects of mirror therapy using a tablet PC for post-stroke central facial paresis. A prospective, randomized controlled study was performed. Twenty-one post-stroke patients were enrolled. All patients performed 15 minutes of orofacial exercise twice daily for 14 days concluded that mirror therapy using a tablet PC might be an effective tool for treating central facial paresis after stroke. The past research records are evident that therapists have worked with mime therapy and mirror therapy. The two protocols have not been complimented for rehabilitation. So the aim of this study is to observe and determine the combined effect of these two treatment protocols to get the results and improve the facial symmetry in acute bell's palsy patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell Palsy, mime therapy, mirror therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mime therapy using tablet PC mirror application
Arm Type
Active Comparator
Arm Description
these individuals will receive mime therapy using tablet PC mirror application
Arm Title
the control intervention including the mime therapy
Arm Type
Experimental
Arm Description
these individuals will receive the control intervention including the mime therapy).
Intervention Type
Other
Intervention Name(s)
mime therapy using tablet PC mirror application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
the control intervention including the mime therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sunnybrook Facial Grading system scale
Description
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.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
House-Brackmann Facial Grading System
Description
The House-Brackmann Facial Nerve Grading System is widely used to characterize the degree of facial paralysis. In this scale, grade I is assigned to normal function, and grade VI represents complete paralysis. Intermediate grades vary according to function at rest and with effort. The tool will be used for assessment
Time Frame
4 weeks
Title
Patients Global Impression of Change
Description
The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. PGIC remains a clinically relevant tool to assess perceived impact of disease management.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Acute bell's palsy ( 2-3 weeks) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Aruba Saeed, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12707657
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
10774308
Citation
Devriese PP. Rehabilitation of facial expression ("mime therapy"). Eur Arch Otorhinolaryngol. 1994 Dec:S42-3. No abstract available.
Results Reference
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PubMed Identifier
24189771
Citation
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.
Results Reference
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PubMed Identifier
16942452
Citation
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.
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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.
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Citation
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.
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Citation
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. Erratum In: Ann Rehabil Med. 2017 Aug;41(4):724.
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Mirror Therapy on PC in Acute Bell's Palsy.

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