| CTRI Number |
CTRI/2024/08/072818 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| 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
|
Effectiveness of Kabat rehabilitation along with Motor imagery |
|
Scientific Title of Study
|
Effectiveness of Kabat rehabilitation along with Motor imagery on the recovery of facial muscle functions in patients with acute 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 |
Dhruv Parmar |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Drs Kiran and Pallavi Patel Global University |
| Address |
Drs Kiran and Pallavi Patel Global University Krishna Edu campus Vadodara Mumbai highway NH 8 varnama vadodara 391243
Vadodara
GUJARAT
391243
India |
| Phone |
9054187850 |
| Fax |
|
| Email |
dhruvparmar461@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragna Landge |
| Designation |
Associate professor |
| Affiliation |
Drs Kiran and Pallavi Patel Global University |
| Address |
Drs Kiran and Pallavi Patel Global University Krishna Edu campus Vadodara Mumbai highway NH 8 varnama vadodara 391243
Vadodara
GUJARAT
391243
India |
| Phone |
7861805233 |
| Fax |
|
| Email |
pragnalandge.kspr@kpgu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pragna Landge |
| Designation |
Associate professor |
| Affiliation |
Drs Kiran and Pallavi Patel Global University |
| Address |
Drs Kiran and Pallavi Patel Global University Krishna Edu campus Vadodara Mumbai highway NH 8 varnama vadodara 391243
Vadodara
GUJARAT
391243
India |
| Phone |
7861805233 |
| Fax |
|
| Email |
pragnalandge.kspr@kpgu.ac.in |
|
|
Source of Monetary or Material Support
|
| Matrusri Davalba Hospital Krishna Edu campus Vadodara Mumbai highway NH 8 varnama vadodara Gujarat India 391243 |
|
|
Primary Sponsor
|
| Name |
Dhruv Parmar |
| Address |
Drs Kiran and Pallavi Patel Global University Krishna Edu campus Vadodara Mumbai highway NH 8 varnama vadodara 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 Dharmesh Contractor |
Matrusri Davalba Hospital |
Matrusri Davalba Hospital Krishna Edu campus vadodara mumbai highway NH8 varnama vadodara 391243
Vadodara
GUJARAT |
9879963156
dharmeshcontractor.kspr@kpgu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for 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 therapy |
Patient will be made sit upright in front of the mirror and they will be performing
traditional facial muscle exercises (eyebrow raising, frowning, nose flaring, blowing,
chewing, drinking water with straw and pronouncing vowels). |
| Intervention |
Kabat rehabilitation along with Motor imagery |
Kabat
rehabilitation is a manual resistance technique that works by stimulating fundamental
patterns of movement, it either facilitates or inhibits the movement. It has been noted to enhance coordination, strength, flexibility, and function of the facial muscles.
According to Kabat, contraction into a weaker muscle is directed by the energy
produced by prevention of motion in a stronger synergist. The therapist can alter the
normal timing by two ways: a) by preventing all the motions of a pattern excluding the
one that is to be emphasized. b) by resisting an isometric or maintained contraction of
the strong muscles in a pattern while exercising the weaker muscles.
The mental representation of movement in the absence of physical movement is
called Motor imagery. The beneficial effects of Motor imagery practice on learning and
motor function in healthy individuals, athletes, and those with neurological illnesses are available.
Motor imagery is adjunct therapy which is used along with Electrical
stimulation, Mirror therapy, facial
expression exercise along with Electrical Stimulation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-60 years.
2. Patient diagnosed with Bell’s palsy and referred to physiotherapist.
3. Patients within one week of onset.
4. Patients must be in good mental condition to follow direction and cooperate throughout the session.
5. House Brackman grade score should be ≥ 3.
|
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of facial/bell’s palsy.
2. Patient with upper motor neuron facial palsy.
3. Tumor of the central nervous system.
4. Patient with history of trauma/fracture of skull bone.
5. Patient undergone recent facial surgery.
6. Patient with skin allergy problem, especially on face.
7. Patient with known case of psychiatric disorder.
|
|
|
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 |
| Sunnybrook Facial Grading Scale |
baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facial disability index |
baseline and after 4 weeks |
| lip mobility index |
baseline and after 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="0"
Months="5"
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
|
- All individuals with unilateral Bell’s palsy who have been referred for the study by an ENT, a physician, or a neurosurgeon will be screened in accordance with the inclusion criteria. The study’s protocol will be explained to willing participants, and their signed consent to participate in the study will be obtained. Patients will be allocated randomly in 1:1 ratio to either Group A: n =15 [Kabat rehabilitation along with Motor imagery] or Group B: n=15 Conventional physical therapy. Outcome measures will be noted at the base line and after 4 weeks of intervention. Outcome measure includes House Brackman Scale, Sunny brook Facial Grading Scale, Face Disability Index, modify lip mobility index Treatment duration for both the groups will be 30-40 minutes, 3 days /week for 4 weeks
- Conventional electrotherapy will be given to both the groups in which patient will be in supine position. Then, Electrical stimulation for interrupted galvanic
current will be given. The process of stimulating includes placing one electrode behind 7th cervical vertebra and other electrode will be placed at facial motor points. Dosage of
stimulation for the facial muscles will be 3 sets of 30 contractions.
- Group A
- patient will first perform the Motor imagery technique. first ask the patient to lie down on the plinth and close the eyes, then ask the patient to relax all body part, then ask the patient to take a deep breath and exhale slowly. then patient will be instructed to perform motor imagery
- after this Kabat rehabilitation will be given, the patient will be in supine lying position and therapist will perform PNF technique
- Group B
- Patient will be made sit upright in front of the mirror and they will be performing traditional facial muscle exercises
- Descriptive Statistical Analysis will be obtained using Frequency, Percentage, Mean, SD, CI, Median and IQR. Paired t-test will be used for the comparison of Pre and post data within the group. Unpaired t-test will be used for the comparison of data between group A and Group B. All the statistical analysis will be performed by using IBM SPSS version 29.0.0
|