To determine the effects of facial neuromuscular retraining, with and without neural mobilization on facial
symmetry and disability in patients with Bell's Palsy.
Design
Randomized Controlled Trial, Single-blinded study design,the sample size will be 44 participants
Settings and conduct
Trail will be conducted at General Hospital, Lahore
Upon randomization, participants will be briefed on their respective therapy programs. The researcher responsible for outcome assessments will remain unaware of the group allocation throughout the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Unilateral loss of facial weakness.
House Brackman grades 3 and 4
Acute onset 1-3 weeks.
No history of earlier Bell's palsy or diabetes(6)
Exclusion Criteria:
Stroke associated with Bell's palsy
Pregnancy
Any fracture, or tumor
Facial surgery
Skin allergy on the face
Facial nerve palsy
Intervention groups
Group A: will receive Facial Neuromuscular Retraining with Neural Mobilization and conventional treatment
(Experimental group)
Group B: will receive Facial Neuromuscular Retraining with conventional treatment (Controlled group)
Main outcome variables
Facial symmetry
Disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240509061716N1
Registration date:2024-05-23, 1403/03/03
Registration timing:registered_while_recruiting
Last update:2024-05-23, 1403/03/03
Update count:0
Registration date
2024-05-23, 1403/03/03
Registrant information
Name
Samima Saeed
Name of organization / entity
Riphah international university
Country
Pakistan
Phone
+92 42 111 747 424
Email address
samimasaeedakhter@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of facial Neuromuscular Retraining with and without neural Mobilization on facial Symmetry and disability in patients with Bell's palsy
Public title
Effects of facial Neuromuscular Retraining with and without neural Mobilization on facial Symmetry and disability in patients with Bell's palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years
Both genders
Unilateral loss of facial weakness
House Brackman grades 3 and 4
Acute onset 1-3 weeks
No history of earlier bell's palsy or diabetes
Exclusion criteria:
Stroke associated with Bell's palsy
Pregnancy
Any fracture or tumor
Facial surgery
Skin allergy on face
Facial nerve palsy
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
A lottery method of randomization using a fishbowl technique will be used by one of the research team members who is not involved in patient recruitment assessment or data analysis. After baseline assessment, eligible subjects will be arbitrarily allocated into group A (facial neuromuscular
retraining with Neural mobilization) and group B (facial neuromuscular retraining). Upon
randomization, participants will be briefed on their respective therapy programs. The researcher responsible for outcome assessments will remain unaware of the group allocation throughout the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessors and participants will be kept unaware of the group assignments to
maintain blinding.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Riphah international university Lahore, Pakistan
Street address
Address: 25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore, 54660, Pakistan
City
Lahore
Postal code
53700
Approval date
2024-04-29, 1403/02/10
Ethics committee reference number
F22C14G37033
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
Facial symmetry, Disability
Timepoint
Before the intervention and three weeks after the intervention
Method of measurement
Sunnybrook Facial Grading System (SBS), Modified House Brackmann grading system (HBGS), and Facial Disability Index (FDI)
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: e Facial Neuromuscular Retraining with Neural Mobilization and conventional treatment group
Category
Rehabilitation
2
Description
Control group: Facial Neuromuscular Retraining with conventional treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
General Hospital Lahore
Full name of responsible person
Mrs.Umoal Bunin Mushtaq
Street address
Ferozpur Road Near Ismail Nagar , Lahore.
City
Lahore
Postal code
54000
Phone
+92 42 99268801
Email
lahoregeneralhospital@yahoo.com
Web page address
https://lgh.punjab.gov.pk/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Faculty of Rehabilitation and Allied Health Sciences(FRAHS)
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore, 54660, Pakistan
City
Lahore
Postal code
05309
Phone
+92 309 3330153
Email
admissions.lahore@riphah.edu.pk
Web page address
https://riphah.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
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
Riphah International University
Full name of responsible person
Dr. SANA RIAZ
Position
Senior lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore, 54660, Pakistan
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 300 0720826
Email
Sana.rcrs@riphah.edu.pk
Web page address
https://riphah.edu.pk/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. SANA RIAZ
Position
Senior lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore, 54660, Pakistan
City
Lahore
Province
Punjab
Postal code
05309
Phone
+92 309 3330153
Email
Sana.rcrs@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Dr. SANA RIAZ
Position
Senior lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore, 54660, Pakistan
City
Lahore
Province
Punjab
Postal code
05309
Phone
+92 309 3330153
Email
Sana.rcrs@riphah.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available