| CTRI Number |
CTRI/2017/03/007981 [Registered on: 01/03/2017] Trial Registered Prospectively |
| Last Modified On: |
21/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison between the effectiveness of two physiotherapy techniques for improving facial symmetry and function in patients with Bells palsy |
|
Scientific Title of Study
|
Comparing the effectiveness of Mime therapy and Neuromuscular re-education in improving facial symmetry and function in Bells palsy: a Randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mr DSouza Arnold Fredrick |
| Designation |
Post graduate Student (Master of Physiotherapy) |
| Affiliation |
Father Muller Medical College |
| Address |
Dept. of Physiotherapy,
Father Muller Medical College,
Kankanady, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620872418 |
| Fax |
|
| Email |
arniephysio94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sydney Roshan Rebello |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Dept. of Physiotherapy,
Father Muller Medical College,
Kankanady, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343569219 |
| Fax |
|
| Email |
sydneypt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr DSouza Arnold Fredrick |
| Designation |
Post graduate Student (Master of Physiotherapy) |
| Affiliation |
Father Muller Medical College |
| Address |
Dept. of Physiotherapy,
Father Muller Medical College,
Kankanady, Mangalore 575002
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9620872418 |
| Fax |
|
| Email |
arniephysio94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mr DSouza Arnold Fredrick
Department of Physiotherapy,
Father Muller Medical College,
Kankanady, Mangalore 575002 |
|
|
Primary Sponsor
|
| Name |
Mr DSouza Arnold Fredrick |
| Address |
Dept. of Physiotherapy
Father Muller Medical College
Kankanady Mangalore 575002 |
| Type of Sponsor |
Other [Self Sponsered] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Sydney Roshan Rebello |
Father Muller Medical College Hospital |
Department of Physiotherapy, R Ward, 3rd Floor
Dakshina Kannada
KARNATAKA |
9343569219
sydneypt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Bells palsy, (1) ICD-10 Condition: G510||Bells palsy, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mime therapy |
Patients will receive the following:
Self-massage, breathing and relaxation exercises, facial exercises, eye and lip closure exercises, articulation and facial expression exercises.
Treatment will be for 1 hour per day for 2 weeks. |
| Comparator Agent |
Neuromuscular re-education |
Patients will receive individually-tailored treatment that includes:
Education, relaxation, initiation, facilitation and motor control.
Treatment will be for 1 hour per day for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Bell’s palsy by a qualified medical practitioner |
|
| ExclusionCriteria |
| Details |
Patients with supra-nuclear lesions
Patients with recurrence of facial paralysis
Patients with sensory deficit over the face
Patients contraindicated for electrical stimulation |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sunnybrook Facial Grading System |
Difference in Sunnybrook score after 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facial Clinimetric Evaluation scale |
Difference in Facial Clinimetric Evaluation scale score after 2 weeks |
| House-Brackmann Classification of Facial Function |
Difference in House-Brackmann Classification of Facial Function after 2 weeks |
|
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Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2017 |
| Date of Study Completion (India) |
20/12/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
DSouza AF, Rebello SR. Comparing the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in acute Bells palsy: a pilot randomised clinical trial. Int J Ther Rehabil. 2021;28(3):1-8. doi: 10.12968/ijtr.2019.0121 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Mime therapy and neuromuscular re-education are two approaches for facial rehabilitation that can promote recovery and improve functionality through the use of biofeedback. Both techniques have been proven to be superior to conventional therapy, but there is no literature comparing the two techniques and its effectiveness on patients with Bell’s palsy. Therefore, it is necessary to evaluate both forms of treatments to determine the most effective and safest treatment for Bell’s palsy. RESEARCH QUESTION: Is there a significant difference in the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with Bell’s palsy? HYPOTHESIS (H1): There is a significant difference in the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with Bell’s palsy.
NULL HYPOTHESIS (H0): There is no significant difference in the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in patients with Bell’s palsy. |