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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04993417
Other study ID # REC/Lhr/20/0209 Aysha
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date June 30, 2021

Study information

Verified date August 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date June 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan Imran Idrees Teaching Hospital Sialkot Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

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. — View Citation

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.

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. Review. — View Citation

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. — View 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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. Epub 2016 May 30. Review. — View Citation

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

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. Review. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Beck Depression Inventory Scale (BDI) 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) 12 Week
Primary 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 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 12 Week
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