To determine the effects of proprioceptive neuromuscular facilitation, mime therapy and sensory exercises on facial symmetry and function in patients with Bell’s Palsy.
Design
randomized controlled trial
Settings and conduct
Setting: Pediatric Physical Therapy and Neuro Rehabilitation Centre, University of Lahore Teaching Hospital
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Age range of 20-45 years
• Both the genders
• Acute cases Bell’s palsy (1-3 weeks) (Mishra & Sayed, 2021)
Exclusion Criteria:
• Dental metal prosthesis
• Participants with cognitive disorders (Mishra & Sayed, 2021)
• Subject along with surgery for ear & facial nerve palsy (Bhagat & Kakkad, 2021)
Intervention groups
Group A: PNF
• In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching and strengthening exercises will be performed for 10 minutes
Group B: PNF, Mime Therapy and Sensory Exercises
• In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching, Mime therapy will be applied for 10 minutes and sensory exercises will be performed with 5 repetitions each for 10 minutes
3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months)
Main outcome variables
Bell’s Palsy:
Bell’s Palsy is a lower motor neuron lesion, the facial symmetry is assessed by Sunnybrooke Facial Grading System.
Facial Function:
The Facial Clinimetric Evaluation Scale (FaCE) is a validated patient-based facial grading instrument developed in 2001.
General information
Reason for update
Acronym
Proprioceptive neuromuscular facilitation
IRCT registration information
IRCT registration number:IRCT20210816052201N3
Registration date:2024-11-16, 1403/08/26
Registration timing:registered_while_recruiting
Last update:2024-11-16, 1403/08/26
Update count:0
Registration date
2024-11-16, 1403/08/26
Registrant information
Name
Sana Akram
Name of organization / entity
The University of Lahore, Lahore Pakistan
Country
Pakistan
Phone
+92 42 35183083
Email address
sana.akram@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-16, 1403/06/26
Expected recruitment end date
2024-11-22, 1403/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
PNF with mime therapy and sensory exercises in patients with bell's palsy
Public title
Proprioceptive neuromuscular facilitation with mime therapy and sensory exercises in patients with bell's palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 20-45 years
Both the genders
Acute cases Bell’s palsy (1-3 weeks)
Exclusion criteria:
Dental metal prosthesis
Participants with cognitive disorders
Subject with surgery for ear & facial nerve palsy
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-operated random approach will be used to divide the subjects into two groups. Recruitment will be done for patients with Bell’s Palsy between the ages of 20 and 45.
Blinding (investigator's opinion)
Single blinded
Blinding description
This is going to be a single blinded study and the outcome assessor will be blind. Assessor will independently collect the data through outcome measures from the patient of group A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee
Street address
The University of Lahore
City
Lahore
Postal code
54000
Approval date
2024-08-13, 1403/05/23
Ethics committee reference number
REC-UOL-/378/08/24
Health conditions studied
1
Description of health condition studied
Bell’s palsy
ICD-10 code
G51.0
ICD-10 code description
Bell's palsy
Primary outcomes
1
Description
the facial symmetry will be assessed by Sunnybrooke Facial Grading System. The system includes three components: (1) resting symmetry, (2) the symmetry of voluntary movements, and (3) synkinesis. The SFGS has high reliability and repeatability which is good to excellent.
Timepoint
The baseline readings will be taken initially, second reading will be taken in 4th week and the follow up reading will be taken in the 6th week
Method of measurement
Functional disability measured by Facial Clinimetric Evaluation Scale (FaCE) Facial symmetry is assessed by Sunnybrooke Facial Grading System
2
Description
The Facial Clinimetric Evaluation Scale (FaCE) is a validated patient-based facial grading instrument developed in 2001. It measures both impairment and disability in facial paralysis and has the potential to be an invaluable adjunct to physician-graded scales. The FaCE scale is a 15-item (questions),five-point Likert scale that consists of six domains. The domains are facial movement, facial comfort, oral function, eye comfort, lacrimal control and social function. Transformed total and domain scores are calculated using specific formulas and the scores obtained range from 0 to 100
Timepoint
The baseline readings will be taken initially, second reading will be taken in 4th week and the follow up reading will be taken in the 6th week
Method of measurement
Functional disability measured by Facial Clinimetric Evaluation Scale (FaCE) Facial symmetry is assessed by Sunnybrooke Facial Grading System
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:PNF, Mime Therapy and Sensory Exercises. 3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching, Mime therapy will be applied for 10 minutes and sensory exercises will be performed with 5 repetitions each for 10 minutes.
Category
Treatment - Other
2
Description
Control group: PNF 3 sessions of 40 minutes will be given to the patient per week for 18 weeks (1.5 months). The baseline readings will be taken initially, second reading will be taken on 4th week. Follow up reading will be taken on 6th week. In the treatment session EMS will be applied for 10 minutes, PNF will be applied for 15 minutes along with stretching and strengthening exercises will be performed for 10 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Physical Therapy and Neuro Rehabilitation Centre, University of Lahore Teaching Hospital
Full name of responsible person
Dr. Samia Sarmad, PT
Street address
The University of Lahore
City
Lahore
Postal code
54000
Phone
+92 332 4212848
Email
samia735@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Professor Dr. Ashfaq Ahmed
Street address
UNIVERSITY OF LAHORE
City
LAHORE
Postal code
54000
Phone
+92 42 32560865
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore, Lahore Pakistan
Full name of responsible person
Ayesha Ahmad
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore, Defence Road Lahore ,Pakistan.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Fax
Email
ayesha.ahmad@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore, Lahore Pakistan
Full name of responsible person
Sana Akram
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore, Defence Road Lahore ,Pakistan.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Fax
Email
sana.akram@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore, Lahore Pakistan
Full name of responsible person
Sana Akram
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Lahore, Defence Road Lahore ,Pakistan.
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 42 35183083
Fax
Email
sana.akram@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
PNF WITH MIME THERAPY AND SENSORY EXCERCISE INPATIENTS WITH BELL'S PALSY
When the data will become available and for how long
data will be available after completion of treatment session. That will be march 2025
To whom data/document is available
data will be visible to academic institutions
Under which criteria data/document could be used
another author of our study is also available for reviewing request
author: ayeshabutt031@gmail.com
From where data/document is obtainable
kindly contact responsible persons of this study
1st Author: ahmadayesha460@gmail.com
corresponding author: sana.akram@uipt.uol.edu.pk
What processes are involved for a request to access data/document
contact to above mentioned person that will provide you as early as posssible