| CTRI Number |
CTRI/2024/08/072356 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of motor imagery and mirror book therapy on facial symmetry and facial functions in patients with Bells Palsy |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of motor imagery and mirror book therapy on facial symmetry and facial functions in patients with Bells Palsy A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragna Landge |
| Designation |
Phd Scholar Associate Professor |
| Affiliation |
Krishna School of Physiotherapy and Rehabilitation |
| Address |
Krishna School of Physiotherapy and Rehabilitation Drs Kiran and Pallavi Patel Global University Krishna Edu campus Vadodara Mumbai NH 8 Varnama Vadodara
Vadodara
GUJARAT
391243
India |
| Phone |
9428427498 |
| Fax |
|
| Email |
pragnalandge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhwanit Shah |
| Designation |
Senior Lecturer |
| Affiliation |
Government Physiotherapy College |
| Address |
Government Physiotherapy College New Civil Hospital Majuragate ring road Surat
Surat
GUJARAT
395001
India |
| Phone |
9033220634 |
| Fax |
|
| Email |
drdhwanit2608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dhwanit Shah |
| Designation |
Senior Lecturer |
| Affiliation |
Government Physiotherapy College |
| Address |
Government Physiotherapy College New Civil Hospital Majuragate ring road Surat
Surat
GUJARAT
395001
India |
| Phone |
9033220634 |
| Fax |
|
| Email |
drdhwanit2608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna School Of Physiotherapy and Rehabilitation Krishna Edu campus Vadodara Mumbai National Highway 8 Varnama Vadodara Pincode 391243 |
|
|
Primary Sponsor
|
| Name |
Pragna Landge |
| Address |
Krishna Edu campus Vdodara Mumbai National highway 8 varnama Vadodara pincode 391243 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pragna Landge |
Matrusri Davalba Hospital |
First floor Physiotherapy OPD vadodara mumbai National highway 8 Varnama Vadodara
Vadodara
GUJARAT |
9428427498
pragnalandge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical and Health research KPGU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G510||Bells palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment |
Mirror feedback exercises will be performed in the front of mirror. Exercises like smiling, frowning, flaring nose, ballon blowing |
| Intervention |
Mirror Book Therapy |
The patients will perform the mirror book exercises. The patient will sit upright maintaining good and proper posture.
The mirror will be kept at the patient eye level. The mirror should be opened to a right angle with the nose touching the outer edge of mirror.
The patient will look into the mirror with both eyes open and only the unaffected half of the face reflecting back. The patient should see the unaffected side of the face twice reflecting, giving the appearance of full-face reflection.
After that the patients will be requested to perform the facial movement as per the therapist commands.
|
| Intervention |
Motor imagery technique |
The patients will perform the motor imagery technique. For that the therapist will tell the patient to relax the face close the eyes and concentrate and imagine doing sufficient complete and symmetrical movements of face. Activate lightly and selectively each different muscle region.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with unilateral bells palsy and referred for physiotherapy
Patient having sufficient physical and mental ability to understand instructions and cooperate throughout the session
|
|
| ExclusionCriteria |
| Details |
Patient with previous history of peripheral facial paralysis
Patient with facial palsy supranuclear lesion or any known cause of infection
Patient with history of trauma fracture of skull bone
Patient undergone recent facial surgery
Patient with skin allergy problem, especially on face
Pharmacological and psychological treatment for psychiatric disorders
Central nervous system tumour
Congenital or syndromic problems
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sunny Brook facial grading system
Facial disability index |
Baseline and at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
House brackmann score
Lip mobility index |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/08/2024 |
| Date of Study Completion (India) |
10/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/05/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study demonstrates the effectiveness of Motor Imagery and Mirror Book Therapy in improving facial symmetry and facial muscle functions in patients suffering from Bell’s Palsy. Mirror Book therapy was found to be more effective as compared to Motor Imagery and conventional physiotherapy in improving voluntary control of the facial muscles and psychosocial well-being of the patients. However, post intervention significant improvements were observed in SFGS domains: resting symmetry, voluntary movement symmetry and the reduction of synkinesis for the patient’s receiving Motor Imagery and Mirror Book Therapy. This indicates that both the technique has the potential to improve the neuromuscular control. Additionally, the results of FDI score indicates the role of these neurocognitive methods in their contribution for the psychological reinforcement that can reduce the facial disability and improve the quality of life as compared to conventional physiotherapy. Overall, the study adds to the understanding of the importance of both these neurocognitive methods for their incorporation in the facial Palsy rehabilitation protocol. |