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

NCT06459830 | Recruiting

• 1 other identifier: REC/RCR & AHS/23/0272
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bell Palsy

Keywords

Bell's palsy; Facial Asymmetry; Facial Paralysis; Mime therapy; Mobilization

Outcome Measures

Primary Outcomes (3)

• 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.

  3rd week

• 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

  3rd week

• 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

  3rd week

Study Arms (2)

Mime Therapy with Neural Mobilization

EXPERIMENTAL

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

Mime Therapy with placebo Mobilization

PLACEBO COMPARATOR

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

Mime Therapy with Neural Mobilization OTHER

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.

Mime Therapy with Neural Mobilization

Mime Therapy with Placebo Mobilization OTHER

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.

Mime Therapy with placebo Mobilization

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ, Kasur (Baba Bulleh Shah Hospital, District Kasur).

Kasur, Punjab Province, Pakistan

RECRUITING

Related Publications (2)

• 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.

  PMID: 18520590 BACKGROUND

• 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.

  PMID: 30916916 BACKGROUND

MeSH Terms

Conditions

Bell Palsy; Facial Asymmetry; Facial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Paralysis; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Saifa Zia

  Riphah International University (Lahore)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wajiha shahid

CONTACT

03214885079; wajishahid89@gmail.com

Mishal Nadeem

CONTACT

03044277412; dr.mishalnadeem307@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: March 25, 2024
• Primary Completion: November 25, 2024
• Study Completion: December 15, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)