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RecruitingNCT06459830Updated Jun 14, 2024

Mime Therapy With and Without Neural Mobilization in Bell's Palsy.

An interventional study of Mime Therapy with Neural Mobilization and Mime Therapy with Placebo Mobilization in Bell Palsy, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

To determine the Effects of Mime Therapy with and without Neural Mobilization on Facial symmetry, Synkinesis and Functional abilities in Patients with Bell's Palsy.

It has been proven that Mime therapy is effective on activating muscles through articulation exercises, facial expression exercises, breathing exercises and facial massages which can alleviate synkinesis, enhance facial symmetry and promote facial functional abilities. On the other hand, facial neural mobilization has recently reported as a safe and effective adjunctive therapy for patients with Bell's palsy due to the facilitation of nerve gliding in the canal impacts by reducing nerve adherence dispersion of noxious inflammatory agents and increasing neural blood supply. So, by incorporating the Neural mobilization with Mime therapy, therapist may enhance overall facial symmetry, reduce the strain on the facial muscles and alleviate synkinesis. So, it may prove to be an upgraded treatment option for clinicians.

Read the detailed description

A randomized controlled trail conducted in 2023, to evaluate the effect of facial neural mobilization over conventional therapy in improving facial symmetry in patients with acute Bell's palsy. The intervention included 10 days of drug therapy including 3 weeks of conventional therapy to the experimental and the control group. However, the experimental group received additional nerve mobilization technique aimed at mobilizing the facial nerve at the origin of external auditory meatus. Facial neural mobilization is likely to be an effective adjunctive intervention in addition to conventional therapy in improving facial symmetry in acute Bell's palsy.

Randomized clinical trial in 2021 aims to compare the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with acute Bell's palsy. Both mime therapy and neuromuscular re-education showed highly significant improvements within each group for both outcomes; they showed no difference between each group for the Sunnybrook Facial Grading System (P=0.212) and Facial Clinimetric Evaluation Scale (P=0.97). Both techniques are equally effective in the recovery of facial symmetry and function in acute Bell's palsy.

Another Author conducted a comparative interventional study in 2020 to compare the effects of Electromyography Biofeedback (EMG BFB) and Mime Therapy on electrophysiological parameters in subjects with Bell's palsy. A group of 31 subjects were selected for the study. Conventional physiotherapy with an EMG BFB and Mime therapy has an equal positive effect on electrophysiological parameters in subjects with Bell's palsy.

Many existing studies highlight the impact of Mime therapy on bell's palsy and related outcomes such as facial symmetry, synkinesis and functional abilities. Also, neural mobilization is reported as a safe and effective adjunctive therapy for patients with Bell's palsy. However, up to the researcher's knowledge, there is no research specifically on combined effects of Mime therapy and neural mobilization in patients with bell's palsy. So, this study aims to bridge this gap by investigating these effects. Moreover, it may help the clinicians to have an upgraded approach to treat these patients.

02

Conditions studied

  • Bell Palsy

Keywords

  • Bell's palsy
  • Facial Asymmetry
  • Facial Paralysis
  • Mime therapy
  • Mobilization
03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 32 is below the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Idiopathic bell's palsy. Age between 20 to 40 years. Both genders Sub-acute Bell's palsy lasting 3-6 months. Unilateral loss of facial weakness Intact taste sensation. House Brackman grade 4 and 5 (moderate to severe Bell's palsy)

Exclusion criteria

Exclusion Criteria:

Facial palsy recurrence. Patients with Diabetes, Hypertension, and any Auto-immune disorder. Chronic bell's palsy patients Patients with upper motor neuron lesions. Other cranial nerves problem. Pregnancy. Dental metal prosthesis. Facial surgery Skin allergy on face. Patients with Ear infection. Patients with Ear implants. Any neuro-degenerative disorder. Patients with Herpes zoster, Otitis media and Ramsay Hunt syndrome

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Mime Therapy with Neural Mobilization

    This group will receive mime therapy and neural mobilization session with resting intervals. 1. Self- facial massages for 10 minutes. 2. Breathing and relaxation exercises . 3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. 4. Exercises to assist with eye and lip closure. 5. Articulation Exercises. 6. Facial expression exercises Facial Nerve Mobilization The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets. All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.

    Other: Mime Therapy with Neural Mobilization

  • Placebo comparator
    Mime Therapy with placebo Mobilization

    Control group will receive mime therapy session with short resting intervals. 1. Self- facial massages for 10 minutes. 2. Breathing and relaxation exercises. 3. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. 4. Exercises to assist with eye and lip closure. 5. Articulation Exercises. 6. Facial expression exercises. Placebo Neural Mobilization Technique: Placebo Mobilization followed all the procedures of real facial mobilization without applying horizontal and circular auricular traction. The purpose of this placebo facial nerve mobilization is not to deprived the control group from therapy. All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.

    Other: Mime Therapy with Placebo Mobilization

Interventions

  • OtherMime Therapy with Neural Mobilization

    Experimental group will receive mime therapy and neural mobilization session with small resting intervals. Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins. Facial Neural Mobilization: Facial mobilization technique will apply when the patient in supine position with head on the table in neural rotation. The circular movement and horizontal traction will be applied 25 times in three sets with a 5-second rest period in between a single manipulation and a 30- second rest period in between the sets. All the participates in the experimental group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.

  • OtherMime Therapy with Placebo Mobilization

    Control group will receive mime therapy and placebo nerve mobilization session with small resting intervals. Self- facial massages for 10 minutes. Breathing and relaxation exercises for 5 mins. Exercises to enhance coordination between both sides of the face and to reduce synkinesis. Exercises to assist with eye and lip closure for 5 mins. Articulation Exercises for 5 mins. Facial expression exercises for 10 mins. Placebo Nerve Mobilization Technique: The placebo nerve mobilization followed all the procedures of real nerve mobilization without applying horizontal and circular auricular traction. The purpose of this placebo nerve mobilization is not to deprived the control group from therapy and equalize the time duration of treatment protocol. All the participates in the control group will receive 15 treatment sessions. Each session will held for 60 minutes per day, 5 days per week, for total duration of 3 weeks.

06

What researchers measure

Primary outcomes

  1. Sunny brook facial grading system

    Facial symmetry was measured using the 13-item SFGS. The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as \[4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis\] with 100 representing normal facial symmetry. The SFGS is as reliable when applied by novice users as by expert users. Researchers are using this method more frequently because it has been demonstrated to be repeatable, to have minimal inter-observer and intra-observer variability, and to be responsive to changes over time and as a consequence to treatments. The SFGS has high reliability and repeatability which is good to excellent ranging from 0.766 to 0.860.

    Time frame: 3rd week

  2. Facial disability index

    The FDI helps to measure the difficulties of the face in activities of daily living such as eating, drinking, and communicating. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The reliability and internal consistency of the FDI (Cronbach's alpha coefficient) was 0.83 for the complete scale. Intra-class correlation was 0.79 (95% CI: 0.71-0.85) and 0.85 (95% CI: 0.78-0.89) for the physical and social well-being subscale

    Time frame: 3rd week

  3. Kinovea Movement Analysis software

    An objective analysis of the human movement can help both clinical assessment and sports performance. Kinovea is a free 2D motion analysis software that can be used to measure kinematic parameters. The Kinovea software is a valid and reliable tool that can measure accurately at distances up to 5 m from the object and at an angle range of 90°-45°. Nevertheless, for optimum results an angle of 90° is suggested and trustworthy instrument because of strong intra rater reliability(0.98-0.99) and inter rater reliability (0.95-0.98). During recording, patients were asked to perform three movements as follows: first, raise the eyebrows (frontalis); second, smile with pursed lips (zygomatic); and third, pout the lips (orbicularis oris). The symmetry ratio was calculated while comparing each side of face

    Time frame: 3rd week

07

Study locations

1 of 1 sites recruiting
  • DHQ, Kasur (Baba Bulleh Shah Hospital, District Kasur).
    Kasur, Punjab, Pakistan
    Recruiting
    • Heena Habib · Contact03334387127
08

References and documents

Publications

  • Cardoso JR, Teixeira EC, Moreira MD, Favero FM, Fontes SV, Bulle de Oliveira AS. Effects of exercises on Bell's palsy: systematic review of randomized controlled trials. Otol Neurotol. 2008 Jun;29(4):557-60. doi: 10.1097/MAO.0b013e31816c7bf1. PubMed 18520590 ↗
  • Paolucci T, Cardarola A, Colonnelli P, Ferracuti G, Gonnella R, Murgia M, Santilli V, Paoloni M, Bernetti A, Agostini F, Mangone M. Give me a kiss! An integrative rehabilitative training program with motor imagery and mirror therapy for recovery of facial palsy. Eur J Phys Rehabil Med. 2020 Feb;56(1):58-67. doi: 10.23736/S1973-9087.19.05757-5. Epub 2019 Mar 27. PubMed 30916916 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06459830
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Mar 25, 2024
Primary completion
Nov 25, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
Jun 14, 2024

Study contacts

wajiha shahid
Contact
wajishahid89@gmail.com
03214885079
Mishal Nadeem
Contact
dr.mishalnadeem307@gmail.com
03044277412
Saifa Zia
principal investigator · Riphah International University (Lahore)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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