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CTRI Number  CTRI/2024/07/071286 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Physiotherapy in Bells palsy based on nerve status 
Scientific Title of Study   Evaluating The Efficacy of Multimodal Physiotherapy In Patients With Idiopathic Facial Palsy Based On Their Electroneurographic Quotient 
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 Gunjan Kumar 
Designation  Associate Professor 
Affiliation  Bihar Neuro 
Address  Department of Neurology Patna Medical College & Hospital
Ajay Bhawan Near Railway Bridge U turn Rukanpura Patna
Patna
BIHAR
800014
India 
Phone  9620299373  
Fax    
Email  drgunjankumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankit Bhargava 
Designation  Dean & Professor 
Affiliation  Jayoti Vidyapeeth Womens University 
Address  Faculty of Physiotherapy Diagnostics
Vedaant Gyan Valley Village-Jharna Mahala Jobner Link Road NH-8 Jaipur Ajmer Express Way
Ajmer
RAJASTHAN
303122
India 
Phone  9590501545  
Fax    
Email  physioankit01@gmail.com  
 
Details of Contact Person
Public Query  
Name  Darshpreet Kaur 
Designation  Chief Physiotherapist 
Affiliation  Bihar Neuro 
Address  Bihar Neuro Department of Physiotherapy 1st Floor
Ajay Bhawan Near Railway bridge U turn Rukanpura Patna
Patna
BIHAR
800014
India 
Phone  9620299373  
Fax    
Email  drdpkaur@gmail.com  
 
Source of Monetary or Material Support  
Bihar Neuro c/o Ajay Bhawan Near Railway bridge U turn Rukanpura Patna-800014 India 
 
Primary Sponsor  
Name  Bihar Neuro 
Address  Ajay Bhawan Near Railway U Turn Rukanpura Patna-800014 Bihar India 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Darshpreet Kaur PT  Bihar Neuro  Depatment of Physiotherapy 1st floor c/o Ajay Bhawan Near Railway bridge U turn Rukanpura Patna-800014Ajay Bhawan Near Railway bridge U turn Rukanpura
Patna
BIHAR 		 9620299373

drdpkaur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BSLEyeCarePatna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G53||Cranial nerve disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Darsh Gunjan’s Bell’s palsy treatment protocol ( Copyrighted Reg. No. L-147405/2024)  Protocol based on baseline evaluation will include: Facial Neuromuscular exercises (for 10 minutes) Facial massage (for 5 minutes with hypoallergic face oil as per patient’s skin type) Facial therapeutic-ultrasound (at evidence based dosage:-frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2, duration 5 min, over mastoid process, painful area identified behind the ear and paralysed muscles delivered through ELECTROSON 900 by Technomed Electronics) LOW LEVEL LASER therapy (at evidence based dosage:- wavelength of 980 nm and frequency of 100 Hz, energy density of 5 J per every point of direct contact with the skin of the face over the superficial nerve courses of the facial nerve, delivered through Tech Laser 302) Advanced Pneumatic Radial shockwave therapy Extracorporeal shockwave therapy (at evidence based dosage:- frequency 2 Hz, Intensity 2 bars, shots: 500, TD-15 delivered through Shockwave pro 1000 by Technomed Electronics) based on degenerative index as calculated from facial nerve conduction study Facial taping (to be removed while sleeping)/ Facial splint Eye care as appropriate Total duration of treatment will be 6-8 weeks 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  - Patients with acute onset due to idiopathic causes 
 
ExclusionCriteria 
Details  - Patient having undergone physiotherapeutic treatment for facial palsy somewhere else.
- Upper motor neuron pathology-induced facial palsy.
- History of recurrent IFP
- History of recent head or neck injury
- No history of ongoing otitis media or ear discharge
- History of ongoing otitis media or ear discharge
- Non co-operative patient

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Facial Nerve Conduction test (ENoG), Blink Reflex analysis and functional outcomes evaluation with House–Brackmann (H-B) grading system and Sunny Brook Scale and 3T MRI brain along with constructive interference
in steady state (CISS) protocol for facial nerve.
 		 Day 0 ; day of admission
Day 10-14 post Bells palsy
Consecutive Day 21 from date of onset till full recovery 
 
Secondary Outcome  
Outcome  TimePoints 
Degeneration index/ Electroneurographic quotient   at the time of
admission, day 10-14 of onset of IFP, then subsequently after every 21 days till 6
months or complete recovery. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drdpkaur@gmail.com].

  6. For how long will this data be available start date provided 31-07-2024 and end date provided 01-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Bell’s palsy is the most common form of acute spontaneous peripheral facial paralysis and can present as unilateral weakness or paralysis of the face. Its spontaneous recovery rate is high, and proper management results in a good prognosis without sequelae . The initial degree of facial paralysis has been regarded as one of the most important prognostic factors for recovery . In clinical practice, the degree of initial facial paralysis is determined by the House-Brackmann (H-B) grade or Sunny brook scale of Facial grading. Facial nerve electrodiagnostics is a well-established and important tool for decision making as it can assist in diagnosis, assess the lesion severity, and aid in decision making. Even though there are evidence regarding efficacy of various physiotherapeutic modalities in management of IFP, still electrical stimulation is the primary treatment physiotherapeutic choice in management of Bell’s Palsy, anecdotal evidence suggests potential negative effects of electrical stimulation in increasing aberrant reinnervation and synkinesis. The objective of the present study is to categorise the extent of nerve damage based on electrophysiological studies and thereafter provide physiotherapeutic treatment based on the degree of damage. 

 
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