Clinical trial NCT04936152: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bell Palsy
Keywords: Bell Palsy
mime therapy
mirror therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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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.

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.

Primary outcomes:
measure: Sunnybrook Facial Grading system scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: House-Brackmann Facial Grading System
timeFrame: 4 weeks
measure: Patients Global Impression of Change
timeFrame: 4 weeks
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Dr Aruba Saeed, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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