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Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients

Primary Purpose

Facial Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Motor imagery technique along with EMS
Mime Therapy along with EMS
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Palsy focused on measuring Facial nerve palsy, Mime therapy, Motor imagery technique

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Imran Idrees Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Mime Therapy along with EMS

Motor imagery technique along with EMS

Arm Description

MT Group: Mime Therapy along with EMS

MIT Group: Motor imagery technique along with EMS

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sunnybrook Facial Grading System (SFGS)
SunnyBrook Facial Grading System is a 13 item evaluating scale. The framework estimates three segments of facial deviation; resting asymmetry, symmetry of voluntary activities and synkinesis. Resting lopsidedness of the eye, cheek and mouth are all things considered scored from 0 to 4 with 4 being the most uneven. Symmetry of the intentional movements; forehead wrinkle, delicate eye conclusion, open mouth grin, growl and lip pucker, are each scored from 0 to 3 with 3 being the most synkinetic, giving an all out scope of 0 to 15

Full Information

First Posted
July 19, 2021
Last Updated
August 5, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04993417
Brief Title
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients
Official Title
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients; A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (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
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.
Detailed Description
Facial palsy is due to the damage in the facial nerve that supplies the muscles of the face. Peripheral facial nerve paralysis can have various causes, such as Bell's palsy, which is the most common cause. Among secondary cause, tumors and the adverse effects of surgery for tumor pathologies such as, acoustic neuroma and facial nerve schwannoma are the most prevalent. The prognosis for FNP is complete recovery in roughly 80% of cases with Bell's palsy, whereas 15% experiences some type of permanent nerve damage, with the remaining 5% enduring severe sequelae. To this end, FNP should be treated in a multidisciplinary setting, in which physical therapy, psychological and medical or surgical interventions are integrated. The current study has compared the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients. The current study was novel in a way that there is no evidence of superiority of any rehabilitative treatment compared with another in the recovery of FNP, which was clearly determined by the current study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Palsy
Keywords
Facial nerve palsy, Mime therapy, Motor imagery technique

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Mime Therapy along with EMS
Arm Type
Experimental
Arm Description
MT Group: Mime Therapy along with EMS
Arm Title
Motor imagery technique along with EMS
Arm Type
Experimental
Arm Description
MIT Group: Motor imagery technique along with EMS
Intervention Type
Other
Intervention Name(s)
Motor imagery technique along with EMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mime Therapy along with EMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
House-Brackmann Scale (HBS)
Description
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.
Time Frame
12th Week
Secondary Outcome Measure Information:
Title
Sunnybrook Facial Grading System (SFGS)
Description
SunnyBrook Facial Grading System is a 13 item evaluating scale. The framework estimates three segments of facial deviation; resting asymmetry, symmetry of voluntary activities and synkinesis. Resting lopsidedness of the eye, cheek and mouth are all things considered scored from 0 to 4 with 4 being the most uneven. Symmetry of the intentional movements; forehead wrinkle, delicate eye conclusion, open mouth grin, growl and lip pucker, are each scored from 0 to 3 with 3 being the most synkinetic, giving an all out scope of 0 to 15
Time Frame
12 Week
Other Pre-specified Outcome Measures:
Title
Beck Depression Inventory Scale (BDI)
Description
The 21-item Beck Depression Inventory comprises of four proclamations that depict expanding powers of depressive symptoms and incorporates substantial and intellectual emotional manifestations, everything is isolated into a scale from 0 to 3, mirroring the patient's feelings in the past fourteen days. An absolute score of each of the 21 things are created; score of 14 or above is demonstrative of depressive indications. Depressive manifestations were sorted as, minimal-moderate (14-19), moderate-severe (20-29) and severe (30-63)
Time Frame
12 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral facial palsy more than 6 months Age 20-60 years House-Brackmann Scale Score ≥3 Both genders Exclusion Criteria: Pregnant women Psychological treatment for any psychiatric disorder Participants with the history of any tumor Diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Ikram, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imran Idrees Teaching Hospital
City
Sialkot
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29110887
Citation
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.
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Citation
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Results Reference
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PubMed Identifier
27939040
Citation
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.
Results Reference
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PubMed Identifier
30172554
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
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Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients

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