- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04993417
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients
August 5, 2021 updated by: Riphah International University
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients; A Randomized Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Sialkot, Punjab, Pakistan
- Imran Idrees Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mime Therapy along with EMS
MT Group: Mime Therapy 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.
|
Experimental: Motor imagery technique along with EMS
MIT Group: 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
House-Brackmann Scale (HBS)
Time Frame: 12th Week
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sunnybrook Facial Grading System (SFGS)
Time Frame: 12 Week
|
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
|
12 Week
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory Scale (BDI)
Time Frame: 12 Week
|
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)
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12 Week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- Jo YK, Lee YJ, Jeon JH, Kim YIJJoHM. Review on Clinical Studies of Facial Palsy Sequelae Treatment. 2019;28(1):1-12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2020
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
July 19, 2021
First Submitted That Met QC Criteria
August 5, 2021
First Posted (Actual)
August 6, 2021
Study Record Updates
Last Update Posted (Actual)
August 6, 2021
Last Update Submitted That Met QC Criteria
August 5, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/20/0209 Aysha
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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