Protocol summary

Study aim
To see the effectiveness of neural mobilization and PNF stretching in Bell's palsy patients. To see which one is more effective treatment for the Bell's palsy.
Design
A Randomized Clinical Trial Study
Settings and conduct
Govt. Allied Hospital Faisalabad; Punjab (Pakistan)
Participants/Inclusion and exclusion criteria
Following are the inclusion criteria :- Patients with idiopathic bell’s palsy. Patients with unilateral bell’s palsy. People who are ranging from 15 years to 45 years of age. Patient who are at grade 2 (mild dysfunction) and grade 3 (moderate dysfunction) according to House Brakmann scale. Patients who are not taking medical treatment for it (For Example NSAIDS or steroids). ANd below are for exclusion criteria:- Patients taking any other treatment for the bell's palsy. Those who refuse for the consent. Those who have any head injury, trauma, psychological disorders or recent surgery. Those who have any other serious co morbidity like malignancy, tumor, neurogenic shock. Patients who have autoimmune disorders. Patients who are taking medications like NSAIDS or Steroids. Patients having traumatic injury. Patients who had recent surgery related to dental, ear, nose or throat.
Intervention groups
Group A = PNF technique/intervention (proprioceptive Neuromuscular Facilitation) Group B= Neural Mobilization/ intervention
Main outcome variables
There are two main outcome varriables used for it. That is House Brackmann Scale (HBS) and Facial Disability Index Scale (FDI)

General information

Reason for update
Acronym
PNF
IRCT registration information
IRCT registration number: IRCT20230721058872N1
Registration date: 2023-09-24, 1402/07/02
Registration timing: retrospective

Last update: 2023-09-24, 1402/07/02
Update count: 0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Maidah Bashir
Name of organization / entity
The University Of Faisalabad
Country
Pakistan
Phone
+92 41 87509715
Email address
maidahbashir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-26, 1402/01/06
Expected recruitment end date
2023-07-26, 1402/05/04
Actual recruitment start date
2023-03-26, 1402/01/06
Actual recruitment end date
2023-03-26, 1402/01/06
Trial completion date
2023-03-28, 1402/01/08
Scientific title
COMPARATIVE EFFECTS OF NEURAL MOBILIZATION AND PROPRIORECEPTIVE NEUROMUSCULAR FACILITATION IN PATIENTS WITH BELL'S PALSY
Public title
Effects of Neural Mobilization and PNF for Bell's palsy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with idiopathic bell’s palsy. Patient who are at grade 2 (mild dysfunction) and grade 3 (moderate dysfunction) according to House Brakmann scale. Patients with unilateral bell’s palsy. People who are ranging from 15 years to 45 years of age. Patients who are not taking medical treatment for it (For Example NSAIDS or steroids).
Exclusion criteria:
Patients taking any other treatment for the bell's palsy. Those who refuse for the consent Those who have any head injury, trauma, psychological disorders or recent surgery Those who have any other serious co morbidity like malignancy, tumor and neurogenic shock. Patients who have autoimmune disorders. Patients who had recent surgery related to dental, ear, nose or throat.
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 36
More than 1 sample in each individual
Number of samples in each individual: 18
N/A
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Tools used in randomization such as table of random numbers. (eg: chit draw by lottary method)
Blinding (investigator's opinion)
Single blinded
Blinding description
single blinded at subject/participant level
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The University Of Faisalabad.
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab (Pakistan)
City
Faisalabad
Postal code
38000
Approval date
2023-03-24, 1402/01/04
Ethics committee reference number
58872

Health conditions studied

1

Description of health condition studied
Bell's Palsy
ICD-10 code
G51
ICD-10 code description
Facial nerve disorders

Primary outcomes

1

Description
House Brackmann Scale (HBS) & Facial Disability Index Scale (FDI)
Timepoint
Primary Outcome measure was taken at baseline of treatment at 1st week, before giving intervention and than measure at end of three weeks after giving treatment.
Method of measurement
primary outcome measurement was taken by analaysis of grade 2, 3 and grade 4 by using House Brackmann scale and Facial Disability Scale by using two dimensions of it that are physical impairement and pschological impairment of Bell's Palsy

Secondary outcomes

1

Description
House Brackmann Scale (HBS) and Facial Disability Index Scale (FDI)
Timepoint
3 Weeks
Method of measurement
At end of treatment session of 3 weeks we analysed grades by House Brackmann Scale (HBS) and physcial and social/psychological impairement by Facial Disability Index Scale (FDI)

Intervention groups

1

Description
Intervention group: PNF
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
The University Of Faisalabad. (Govt, Allied Hospital. Faisalabad)
Full name of responsible person
Dr. Marium Zafar; PT
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab /Dr. Tusi Rd, Faisalabad, Punjab.
City
Faisalabad
Postal code
38000
Phone
+92 300 4561972
Email
marium.zafar@tuf.edu.pk
Web page address
https://tuf.edu.pk/n/departments-details/department-of-rehabilitation-sciences

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Maidah Bashir
Street address
House No 126, Chambeli Block; The Four Seasons Housing Society - Faisalabad.
City
Faisalabad
Postal code
38000
Phone
+92 322 7810920
Email
maidahbashir@gmail.com
Web page address
https://tuf.edu.pk/n/contact
Grant name
nill
Grant code / Reference number
nill
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
N/A
Proportion provided by this source
1
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
Maidah Bashir
Full name of responsible person
The University Of Faisalabad
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No 126, Chambeli Block; The Four Seasons Housing Society - Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+93 22 781 0920
Email
maidahbashir@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad.
Full name of responsible person
Dr. Marium Zafar; PT
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
University Avenue, Faisal Town Canal Road, Faisalabad, Punjab /Dr. Tusi Rd, Faisalabad, Punjab.
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 300 4561972
Email
marium.zafar@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad.
Full name of responsible person
Maidah Bashir
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House No 126, Chambeli Block; The Four Seasons Housing Society - Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 322 7810920
Email
maidahbashir@gmail.com
Web page address
https://www.linkedin.com/in/maidah-bashir-6a22621a1/?trk=people_directory&originalSubdomain=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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comaprative Effects of Neural Mobilization and PNF stretching in patients with Bell's Palsy
When the data will become available and for how long
(staring in september 2023)- (staring 12 months after publication)
To whom data/document is available
academics institutions
Under which criteria data/document could be used
under the RCT studies
From where data/document is obtainable
https://www.linkedin.com/in/maidah-bashir-6a22621a1/
What processes are involved for a request to access data/document
https://www.linkedin.com/in/maidah-bashir-6a22621a1/
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