| CTRI Number |
CTRI/2025/07/091353 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Taping in Patient with Bells Palsy |
|
Scientific Title of Study
|
Effect of Neuromuscular Taping in Patients with Bell’s 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 |
Sarita Pandey |
| Designation |
Post Graduate Student |
| Affiliation |
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Ambala HARYANA 133207 India |
| Phone |
07988605675 |
| Fax |
|
| Email |
pandeysarita390@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kanika |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Ambala HARYANA 133207 India |
| Phone |
8826903418 |
| Fax |
|
| Email |
kanika.k160@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kanika |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 Ambala HARYANA 133207 India |
| Phone |
8826903418 |
| Fax |
|
| Email |
kanika.k160@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sarita Pandey |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Neuro OPD, Ground Floor, Room no.1 Mullana- Ambala, Haryana, 133207 |
| 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 Kanika |
Neurophysiiotherapy OPD |
Neurophysiotherapy OPD, Ground Floor, Room no.1 Maharishi Markandeshwar Deemed to be University, Mullana, Ambala, Haryana Ambala HARYANA |
08826903418
kanika.k160@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC- 3456 |
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 |
| Intervention |
Neuromuscular Taping |
Neuromuscular Taping for consecutive 1week and Conventional Physical Therapy for two times a day for 1 week |
| Comparator Agent |
Sham NMT for 6 consecutive days and conventional physical therapy for two times a day for 1 week |
Patients in control group will receive Sham NMT taping + Conventional exercise (same as EG).
Sham NMT will be applied on the Frontalis, Orbicularis, Risorius, Buccinator, Levator Angulli Oris, Levator Labii Superior muscle done in an inappropriate manner by not covering the whole muscle and is applied from insertion to origin. Conventional exercise includes Facial soft tissue manipulation followed by MIME exercises. Effleurage and kneading soft tissue manipulation will be applied over the entire face and neck of the affected side. Mime exercise will be performed in front of mirror including (1) passive raising an eyebrow; (2) passively eyebrows to be bought closer to each other; (3) passive opening and closing the eyes; (4) passive mouth blowing movement; and (5) passive smiling each for 10 repetitions, two times a day for 1 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female, aged 18-60 years
Referred cases of Bell’s Palsy
Acute onset within 48hrs
House Brackmann grade (III)
|
|
| ExclusionCriteria |
| Details |
Patients having cognitive impairment.
Recurrent Facial palsy
Hypertension, Diabetes
Patients with bell’s palsy who had undergone any surgical procedure for head and neck in the last 6 months
Any allergy to tape
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
House Brackmann Scale
|
Baseline, 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Facial Disability index scale (FDI)
Facial Clinimetric Evaluation (FaCE)
|
baseline to post-intervention, 1 week |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Background: Bell’s palsy, a type of peripheral facial palsy affects the superior and inferior hemiface.It results from the dysfunction of the facial nerve (cranial nerve VII), which is responsible for the innervation of the mimetic muscles of the face. Bell’s Palsy (BP) is the most common cause of facial nerve palsy accounting for 49-51% of all cases, with an estimated annual prevalence of 20-32.2 per 100,000 people. Its incidence is higher in the ages of 15-45 years and there is a recurrence rate of 8-12%. Neuromuscular Taping (NMT) is a technique of applying elastic adhesive tape to the skin without any tension over the target area which will create wrinkles in skin causing dilation effect on the underlying body tissue, thereby inducing pain relief, facilitation of lymphatic flow and increased vascularityand musculoskeletal systems by employing decompressive stimulation. Purpose: To determine the effectiveness of Neuromuscular Taping on Facial Disability in Patients with Bell’s Palsy. Methods: Patients of Bell’s palsy will be recruited based on inclusion and exclusion criteria. Using sequentially numbered, opaque, sealed envelopes, the participants will be randomly allocated into two groups. After obtaining the informed consent from each participant, treatment will be given. Experimental group (EG) will receive treatment with neuromuscular taping and conventional exercises, and control group (CG) will receive sham neuromuscular taping and conventional exercises for consecutive 6 days for one week. Outcome measures, such as House- Brackmann grade, Facial clinimetric scale and Facial index scale will be used. Results: The obtained data will be analysed using appropriate statistical test based on the normality of the obtained data. |