to compare the effect of kabat technique vs facial neuromuscular re-education technique to reduce facial disability and synkineis in bell's palsy patients
Design
parallel group, single blinded, randomized control trial
Settings and conduct
OPD physiotherapy department mayo hospital
Participants/Inclusion and exclusion criteria
• INCLUSION CRITERIA:
a) Age: 20-60 years
b) Diagnosed cases of Bell’s palsy
c) Non traumatic origin
d) onset(0-6 months )
• EXCLUSION CRITERIA:
a) Psychiatric patients or non-cooperative patients
b) Patients complaining of other neurological deficits
c) Post-surgical cases
d) Neurotemesis
e) Upper motor neuron lesion
f) Any underlying terminal disease
Intervention groups
group A kabat technique
group B neuromuscular re-education technique
Main outcome variables
syninesis and facial disability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054955N1
Registration date:2023-01-23, 1401/11/03
Registration timing:retrospective
Last update:2023-01-23, 1401/11/03
Update count:0
Registration date
2023-01-23, 1401/11/03
Registrant information
Name
Rabia Rahim
Name of organization / entity
King edward medical university lahore
Country
Pakistan
Phone
+92 321 4558408
Email address
rabiarahim08@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-05, 1401/01/16
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
2022-04-11, 1401/01/22
Actual recruitment end date
2022-07-10, 1401/04/19
Trial completion date
2022-07-10, 1401/04/19
Scientific title
effect of kabat technique vs facial neuromuscular re-education technique to reduce facial disability and synkinesis in bell's palsy patients
Public title
effect of kabat technique vs facial neuromuscular re-education technique to reduce facial disability and synkinesis in bell's palsy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 20-60 years
Diagnosed cases of Bell’s palsy
Non traumatic origin
onset(0-6 months
Exclusion criteria:
a) Psychiatric patients or non-cooperative patients
Patients complaining of other neurological deficit
Post-surgical cases
Neurotemesise
Upper motor neuron lesion
Any underlying terminal disease
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
85
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
it was a single blinded randomized conrol trial.. all he participants who came o physiotherapy department diagnosed with bells palsy were considered . 70 patients were alotted in two groups via lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
in this study participants are blinded for treatment technique. two different techniques were provided to patients and they were blind about that which technique is given to which patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
advanced studies and research board
Street address
Neela Gumbad, New anarkali, Lahore
City
lahore
Postal code
36121
Approval date
2022-04-05, 1401/01/16
Ethics committee reference number
2543/KEMU/2022
Health conditions studied
1
Description of health condition studied
Bells' palsy patients
ICD-10 code
G51
ICD-10 code description
Facial nerve disorders
Primary outcomes
1
Description
facial disability
Timepoint
baseline, after three weeks and after 6 weeks
Method of measurement
facial disability index
2
Description
synkinesis
Timepoint
baseline,after 3 weeks and after 6 weeks
Method of measurement
sunny brook facial grading score
Secondary outcomes
empty
Intervention groups
1
Description
Group A will recieve the Kabat technique . Kabat et al. invented it. It is a manual resistance exercise that stimulates fundamental movement patterns, activates proprioceptors, accelerates the neuromuscular mechanism's response, and either promotes facilitation or inhibits it. It also improves flexibility, strength, and coordination.Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.• For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour.
Category
Treatment - Devices
2
Description
Intervention group: Received neuromuscular re-education techniqueThe patient was placed into one of four treatment-based categories—initiation, facilitation, movement control, and relaxation—based on their impairment on the Sunny Brook Facial Grading Scale (SFGS).Conventional treatment includes:• Galvanic current interrupted by 100 milliseconds, rectangular waveform, three sets, and three contractions in each set • Facial massage by hand: effleurage, kneading, wringing, hacking, tapping, and stroking from finger to thumb are all forms of exercise.• For a total of six weeks, intervention was provided twice per week. One session of treatment lasted between 45 and an hour.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
OPD physiotherapy department Mayo hospital lahore
Full name of responsible person
RABIA RAHIM
Street address
86-B rehman pura muslim town
City
lahore
Postal code
54000
Phone
+92 321 4558408
Email
rabiarahim08@ymail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
king edward medical university
Full name of responsible person
dr muhammad iqbal
Street address
neela gumbad , new anarkali lahore
City
lahore
Postal code
36121
Phone
+92 300 8020301
Email
iqbaldr1069@gmail.com
Grant name
rabia rahim
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
king edward medical university
Proportion provided by this source
20
Public or private sector
Public
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
king edward medical university
Full name of responsible person
Rabia Rahim
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
physiotherapist
Street address
86-B rehman pura lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 321 4558408
Email
rabiarahim08@ymal.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
king edward medical university
Full name of responsible person
dr muhammad iqbal
Position
professor
Latest degree
Medical doctor
Other areas of specialty/work
orthopedic doctor
Street address
neela gumbad , new anarkali lahore
City
lahore
Province
punjab
Postal code
36121
Phone
+92 300 8020301
Email
iqbaldr1069@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
king edward medical university
Full name of responsible person
Rabia Rahim
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
physiotherapist
Street address
86 B rehman pura lahore
City
lahore
Province
punjab
Postal code
36121
Phone
+92 321 4558408
Email
rabiarahim08@ymail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
EFFECT OF KABAT TECHNIQUE AND FACIAL NEUROMUSCULAR RE-EDUCATION TECHNIQUE TO REDUCE FACIAL DISABILITY AND SYNKINESIS IN BELLS PALSY PATIENTS
When the data will become available and for how long
study is completed and become available after its publication
To whom data/document is available
person in academic institute.patient data will not be shown
Under which criteria data/document could be used
under the usage with terms in which journal is accessed / processed for publication it could be used on request
From where data/document is obtainable
from the university office and responsible supervisor and from journal we will process in future
What processes are involved for a request to access data/document
can be on call or mail it will be only used in confidential way for improving reseaerch and benifit of humanity