| CTRI Number |
CTRI/2025/07/091685 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare two interventions, mirror book therapy and mirror exercises, for improving facial function and quality of life in people with Bells palsy |
|
Scientific Title of Study
|
To compare the effect of mirror book therapy and mirror exercises on facial function and health related quality of life in patients with Bells palsy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8901874043 |
| Fax |
|
| Email |
pooja041103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Mehra |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Mehra |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Physiotherapy Department, Teaching Staff Room, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak, Haryana, India, 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, PGIMS, Rohtak |
| Address |
Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak, Haryana, India, 124001 |
| Type of Sponsor |
Government medical college |
|
|
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 Suman Mehra |
Pt. B. D. Sharma University of Health Sciences, PGIMS |
Neurology Department, Ward No 32, Lala Shyam Lal Super Speciality Block and Physiotherapy Department, College of Physiotherapy, Pt. B. D. Sharma University of Health Sciences, PGIMS, Rohtak, Haryana
Rohtak
HARYANA |
8814063412
sumanmehra2017@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G09||Sequelae of inflammatory diseasesof central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIRROR BOOK THERAPY |
Patient will be seated in front of mirror book and perform facial exercises so that only non-affected side of face is reflected back twice in mirror book while holding the contractions for 3 seconds with 3-5 seconds rest in between.
Dosimetry: 5-10 repetitions each, for 3 days a week for 4 weeks |
| Comparator Agent |
MIRROR EXERCISES |
Patient will be seated in front of simple mirror and will do the facial exercises so that both sides of face is visible in the mirror while holding the contractions for 3 seconds with 3-5 seconds rest in between. Dosimetry: 5-10 repetitions each, for 3 days a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of unilateral Bells palsy within 1-3 weeks of onset
2.Patients with moderate to severe facial paralysis with Housebrackmann facial nerve grade III-V
3.Patients with ability to understand and follow commands
|
|
| ExclusionCriteria |
| Details |
1.Patients with previous history of peripheral facial paralysis
2.Facial palsy due to supranuclear lesion or known cause of infections, tumor
3.Patients with skin allergy problems on face
4.Patients with history of trauma to skull bone
5.Patients who undergone facial surgery
6.Patients with psychiatric disorders
7.Metal implants around the head and neck area
8.Sensory loss, ulcer or wound over the face
9.Patients with total facial paralysis with Housebrackmann facial nerve grade VI
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sunnybrook Facial Grading System
and Facial Disability Index |
At baseline (day 0), post intervention (week 4).
Follow up will be done at 4- week post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facial Clinimetric Evaluation Scale |
At baseline (day 0), post intervention (week 4).
Follow up will be done at 4- week post intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study aims to compare the effectiveness of mirror book therapy and mirror exercises on facial function in patients with Bell’s palsy. The study will recruit 30 patients who will be randomly assigned to either the mirror book therapy group or the mirror exercise group. Both groups will receive treatment for 4 weeks, and outcomes will be assessed using standardized measures. The study will evaluate the impact of these therapies on facial function, facial disability, and quality of life. |