Proprioceptive neuromuscular facilitation in adjunct to mirror therapy on clinical recovery ,synkinesis and quality of life in patients with Bell's palsy
1) To determine the effects of Proprioceptive Neuromuscular facilitation with and without Mirror Therapy on clinical recovery in Bell’s palsy patients
2) To determine the effects of Proprioceptive Neuromuscular facilitation with and without Mirror Therapy on synkinesis in Bell’s palsy patients
3) To determine the effects of Proprioceptive Neuromuscular facilitation with and without Mirror Therapy on quality of life in Bell’s palsy patients
Design
Two arm parallel group randomized trail with blinded assessor and outcome assessment of 60 participants
Settings and conduct
Data will be conducted from department of Physical Therapy, Sir Ganga Ram Hospital, Lahore. This is a single blinded study in which outcome evaluation assessor will be unaware of treatment which assigned to groups. Data will be assessed by assessor at baseline, at the end of 3rd week, at the end of 6th and at the end of 9th week.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Aged between 25-50 years
• Both Male and females
• Patients with unilateral Bells’ Palsy diagnosed by neurologist
• Patients with moderate to severe Bell’s palsy (House-Brackmann Scale facial nerve grading 3 and 4)
• Patients with unilateral bell’s palsy
Exclusion Criteria:
• Patients with Autoimmune/ hematologic disease
• Patients with Inflammatory disease(e.g. Rheumatoid arthritis)
• Patients with any neurodegenerative disease
• Patients with cognitive impairments
Intervention groups
All the screened and willing participants will be randomly allocated to two groups where Group A will receive proprioceptive neuromuscular facilitation with mirror therapy and Group B will receive proprioceptive neuromuscular facilitation without mirror therapy by lottery method.
Main outcome variables
House Brackman scale(HBS), Synkinesis Assessment Questionnaire, and Facial clinimetric Evaluation Scale(FaCE)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241001063232N1
Registration date:2024-10-20, 1403/07/29
Registration timing:retrospective
Last update:2024-10-20, 1403/07/29
Update count:0
Registration date
2024-10-20, 1403/07/29
Registrant information
Name
Sadia Ghafoor
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 300 9477922
Email address
sgrana14@outlook.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-15, 1402/11/26
Expected recruitment end date
2024-10-01, 1403/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Proprioceptive neuromuscular facilitation in adjunct to mirror therapy on clinical recovery ,synkinesis and quality of life in patients with Bell's palsy
Public title
Proprioceptive neuromuscular facilitation in adjunct to mirror therapy on clinical recovery ,synkinesis and quality of life in patients with Bell's palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 25-50 years
Both Male and females
Patients with unilateral Bells’ Palsy diagnosed by neurologist
Patients with moderate to severe Bell’s palsy (House-Brackmann Scale facial nerve grading 3 and 4)
Patients with unilateral bell’s palsy
Exclusion criteria:
Patients with Autoimmune/ hematologic disease
Patients with Inflammatory disease(e.g. Rheumatoid arthritis)
Patients with any neurodegenerative disease
Patients with cognitive impairments
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization will be used by one of the research team members who will be blinded and not involve in patients recruitment or assessment or data analysis. Participants are randomly allocated into two groups through lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
This is single blinded study in which accessor will be unaware of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of University of Lahore
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Approval date
2024-03-07, 1402/12/17
Ethics committee reference number
REC-UOL-671-03-2024
Health conditions studied
1
Description of health condition studied
Bell palsy is an idiopathic peripheral nerve disorder involving the facial nerve (ie, cranial nerve VII) and manifesting as acute, ipsilateral facial muscle weakness. It affects individuals across multiple ages and both sexes, with an annual incidence ranging from 11.5 to 53.3 per 100,000 persons across multiple populations.
ICD-10 code
G51.0
ICD-10 code description
Bell's palsy
Primary outcomes
1
Description
The House-Brackmann Scale (HBS) is one of several analysis tools that have been developed to quantify facial function and provide reproducible information in measuring the global degree of paresis and paralysis.
Timepoint
9th weeks
Method of measurement
It is a widely accepted system and is simple, sensitive, accurate, and reliable, grading facial function in 6 stages, from normal (HB I) to total paralysis (HB VI).
2
Description
The Synkinesis Assessment Questionnaire comprises nine questions and is a valid and reliable measurement for synkinesis. It correlates well with the synkinesis aspect of FGS.
Timepoint
9th week
Method of measurement
Chuang et al. introduced a four-category classification: I) Good smile with mild synkinesis, II) Acceptable smile with moderate to severe synkinesis, III) Unacceptable smile with severe synkinesis, and IV) Poor smile with mild synkinesis.
3
Description
The Facial Clinimetric Evaluation Scale (FaCE) is a patient-based instrument that measures facial impairment and disability in evaluating quality-of-life issues that are caused by facial disability.
Timepoint
9th weeks
Method of measurement
This questionnaire consists of 15 questions on a 5-point Likert Scale and comprises 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. Total and domain scores range from 0 (worst) to 100 (best). This scale has been used in several studies on patient satisfaction following treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants randomly allocated in Group A will be received the PNF with mirror therapy (MT). After electrical muscle stimulation proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch as shown in figure 1 using mirror. Participants will be sit upright, maintaining good posture. Keep mirror at eye level. With both eyes open, look into mirror with only on unaffected side. Patients will be observed the mirror reflection for one to two minutes, then trying to visualize the mirror image as the affected side. Once the subject will be engaged with mirror side then proprioceptive exercises will be performed.
Category
Treatment - Other
2
Description
Intervention group: In group B patients will be received PNF without mirror therapy (MT). After electrical muscle stimulation, proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sir Ganga Ram Hospital
Full name of responsible person
Momna Asghar
Street address
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
City
Lahore
Postal code
55150
Phone
+92 304 7487995
Email
momna.asghar@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Sadia Ghafoor
Street address
1 km Defence Road near Bhuptian Chowk Lahore Punjab
City
Lahore
Postal code
55150
Phone
+92 300 9477922
Email
Sgrana14@outlook.com
Grant name
No
Grant code / Reference number
none
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
University of Lahore
Full name of responsible person
Sadia Ghafoor
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-kn Defence Road near Bhuptian Chowk Lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 304 787995
Email
sgrana14@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Sadia Ghafoor
Position
Punjab
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence road near Bhuptian Chowk Lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 304 787995
Email
sgrana14@outlook.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Sadia Ghafoor
Position
Concultant
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1 km Defence road Bhubtian chowk Lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 304 787995
Email
sgrana14@outlook.com
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and data related to final outcome will be shared by maintaining the confidentially
When the data will become available and for how long
Data will be available after the publication of findings till six months
To whom data/document is available
Sadia Ghafoor
Under which criteria data/document could be used
For research purpose
From where data/document is obtainable
To the corresponding author of the study , Sadia Ghafoor and can contact on +92 304 787995 , sgrana1@outlook.com
What processes are involved for a request to access data/document
Open access and there is the traditional public data release where anyone can get access to the data