| CTRI Number |
CTRI/2025/02/080131 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| 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
|
Improvement by neural mobilisation of facial nerve on face movement in bells palsy |
|
Scientific Title of Study
|
Effect of Neural Mobilization on Facial Function In Patient with Bells Palsy:An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Simran Yasinkhan Pathan |
| Designation |
Masters of Neurophysiotherapy Student |
| Affiliation |
Maharashtra Institute of Physioyherpy Latur |
| Address |
Maharashtra Institute of
Department of neurophysiothrapy, OPD-16, Mahatashtra institute Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
7219757318 |
| Fax |
|
| Email |
simranypathan2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor Of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of
Department of neurophysiothrapy, OPD-16, Mahatashtra institute Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Singh Mandade |
| Designation |
Professor Of Neurophysiotherapy Department |
| Affiliation |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute of
Department of neurophysiothrapy, OPD-16, Mahatashtra institute Physiotherapy, MIMSR medical campus, Ambajogai Road, Latur
Latur
Latur
MAHARASHTRA
413531
India |
| Phone |
797250020 |
| Fax |
|
| Email |
drneha9559@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy, Latur 413531 |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy, Latur |
| Address |
Maharashtra Institute Of Physiotherapy, MIMSR Medical campus, Ambajogai Road, Latur 413531 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Simran Yasinkhan Pathan |
Maharashtra Institute Of Physiotherapy, Latur |
Maharashtra
Institute Of
Physiotherapy,
Medical campus
MIMSR, Ambajogai
Road, Latur
Latur
MAHARASHTRA
Latur
MAHARASHTRA |
7219757318
simranypathan2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comittee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B349||Viral infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Electrical nerve stimulation |
45 contractions for 2 sets |
| Intervention |
facial nerve mobilizaion |
25 times 3 sets 5 days / week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
patient with Acute Bell’s palsy
Patient with Unilateral & Idiopathic Bell’s palsy Age group 15 to 45 years of both gender |
|
| ExclusionCriteria |
| Details |
Patient with UMN facial palsy
non-cooperative patient
patient with open wounds over head and neck
recent dental surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)House brackmanns scale
2)sunny brook facial grading scale
|
preintervention mid at end of 2nd week and postintervnetion at end of 3 rd week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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
|
Patient will be screened as per the inclusion and exclusion criteria.
Aim, objectives & treatment procedure will be explained to the
participants and written consent will be taken. Then patient will be randomly allocated into two groups Group A
(Experimental Group) & Group B (Control Group) by chit method.
Patient will be examined as per data collection sheet. both groups
will be receiving treatment for 5 days /week for 3 weeks GROUP A - Neural mobilization for facial nerve along with
conventional therapy (14 patient)
The therapist used one hand to perform facial nerve
mobilization, while the other hand was used to stabilize the
patient’s head by placing the palm on the unaffected side of
the face. The hand placement on the affected side is such that
the therapist’s index finger circle behind the auricle of the ear
and the thumb is gently placed at the opening of the external
auditory meatus. The circular movement and horizontal traction were 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 set. GROUP B –conventional therapy
EMS (Electrical Muscle stimulation) interrupted Galvanic
current for facial muscles 45 contraction for two set.
Faradic current to facial nerve trunk 10 contraction 2 set
Facial exercise 3 times /day in front of mirror each exercise for
10 times
Patient will be assessed with house brackmann scale and
sunnybrook as outcome at the baseline, at the end of 2
nd
second week & end of 3rd week.
• Patient will be assessed with house brackmann scale and
sunny brook scale as outcome to pre- test and post test result.
|