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Effectiveness of Kabat Exercises along with Mirror Therapy in Bell's palsy

Protocol summary

Study aim
The aim of this study is to explore the effect of Kabat exercises along with mirror therapy in Bell's palsy in improving facial movement and asymmetry
Design
The 32-patient age range of 25–50 years was included in this study. In this randomized clinical trial, the non-probability purposive sampling technique (random allocation to groups by means of the lottery method) was used. Randomization was done into 2 groups (treatment group and control group.
Settings and conduct
Faisal Hospital, Rubina memorial Hospital, Madinah teaching Hospital, Allied hospital Faisalabad, Mujahid Hospital, Shahid Ahmed heera’s Health Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: Both genders, Male and Female, Age of 25–50 years, Acute onset (1-3 weeks), BP diagnosed with HBGS (grades III and IV), Facial asymmetry checked with FDI. Exclusion criteria: Patient having psychological problems, Hypertensive patient, Neurological deficit, Sensory deficit, Stroke, MS.
Intervention groups
In the treatment group intervention, Kabat exercise along with mirror therapy for 12 sessions over 4 weeks, 3 times per week, for 10-15 minutes. In the control group only Kabat exercise was given for 12 sessions over 4 weeks, 3 times/week for 10-15 minutes.
Main outcome variables
Facial movement (like eye closing, blinking, lip closing smile) and asymmetry

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230706058696N1
Registration date: 2023-09-09, 1402/06/18
Registration timing: retrospective

Last update: 2023-09-09, 1402/06/18
Update count: 0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Aqsa Waheed
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 300 6620110
Email address
aqsawaheed48@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-12, 1402/01/23
Expected recruitment end date
2023-06-28, 1402/04/07
Actual recruitment start date
2023-04-26, 1402/02/06
Actual recruitment end date
2023-07-05, 1402/04/14
Trial completion date
2023-07-10, 1402/04/19
Scientific title
Effectiveness of Kabat Exercises along with Mirror Therapy in Bell's palsy
Public title
Effectiveness of Kabat Exercises along with Mirror Therapy in Bell's palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 25–50 years Acute onset (1-3 weeks) Diagnosed with House Brackmann grading index (grades III and IV), Both genders, Male and female,
Exclusion criteria:
Patient having psychological problems Hypertensive patient Having Neurological deficit Having any Sensory deficit Patient having Stroke
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Actual sample size reached: 32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study purposive sampling technique by random allocation to groups by means of lottery method used in this study. In lottery method we make 32 chits, 16 each of both group with the name of a treatments written on it. The chits are placed in a container and ask patient to pick 1 chit from the container.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics / Technical committee
Street address
Faisal Town, West Canal Road
City
Faisaalabad
Postal code
38000
Approval date
2023-03-10, 1401/12/19
Ethics committee reference number
2021-MSPT-052

Health conditions studied

1

Description of health condition studied
bells palsy
ICD-10 code
G51.0
ICD-10 code description
Bell's palsy

2

Description of health condition studied
facial movement
ICD-10 code
R29.810
ICD-10 code description
Facial weakness

3

Description of health condition studied
facial asymmetry
ICD-10 code
Q67.0
ICD-10 code description
facial asymmetry

Primary outcomes

1

Description
facial movements
Timepoint
1st day of treatment , 4th week at the end day of treatment and after 1 month as a follow-up
Method of measurement
House Brackmann Grading Index and Facial Disability Index

2

Description
facial asymmetry
Timepoint
1st day of treatment , 4th week at the end day of treatment and after 1 month as a follow-up
Method of measurement
House Brackmann Grading Index and Facial Disability Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In Group 1, the treatment intervention was Kabat exercise along with mirror therapy for 12 sessions over 4 weeks, 3 times per week for 10-15 minutes.
Category
Rehabilitation

2

Description
Control group: In the control group, only Kabat exercises were given for 12 sessions over 4 weeks, 3 times per week for 10-15 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faisal hospital
Full name of responsible person
Nabeel Zahid , Sarwat Mehmood
Street address
673-A Lower Canal Rd E, Block A People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8719677
Email
aqsawaheed48@yahoo.com

2

Recruitment center
Name of recruitment center
Mujahid hospital
Full name of responsible person
DR Khalid
Street address
Mujahid Hospital, P-103 Z Block Madina Town, Green Belt, Susan Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 8841364
Email
aqsawaheed48@yahoo.com

3

Recruitment center
Name of recruitment center
Rubina Memorial Hospital
Full name of responsible person
DR Dawood
Street address
717-A Satayana Rd, Batala Colony Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8738885
Email
aqsawaheed48@yahoo.com

4

Recruitment center
Name of recruitment center
Dr Shahid Ahmed Heera Clinic
Full name of responsible person
Saqib Imran
Street address
Main Blvd, near Manzar Medical Center & Poly Clinic, D Ground Block D People's Colony No 1, Faisalabad, Punjab
City
Faisalabad
Postal code
38000
Phone
+92 41 8727918
Email
aqsawaheed48@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Sidra Majeed
Street address
The University of Faisalabad
City
faisalabad
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Faisalabad
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 Faisalabad
Full name of responsible person
Dr Sidra Majeed
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisal town west canal road
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8868326
Email
info@tuf.edu.pk
Web page address
https://www.tuf.edu.pk/

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Aqsa Waheed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
New hasseb shaheed calony,house 1, street 1
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 335 6663110
Email
aqsawaheed48@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University f Faialabad
Full name of responsible person
Aqsa Waheed
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
New hasseb shaheed calony,house 1, street 1
City
Faisalabas
Province
Punjab
Postal code
38000
Phone
+92 335 6663110
Email
aqsawaheed48@yahoo.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
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
Not applicable
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
Effectiveness of Kabat exercises along with mirror therapy in Bell's palsy
When the data will become available and for how long
3 months
To whom data/document is available
people working in academic institutions.
Under which criteria data/document could be used
IPD and any other additional documents
From where data/document is obtainable
contact person: Aqsa Waheed Contact no. 92335-6663110
What processes are involved for a request to access data/document
Data will be provided by contacting the above mentioned person.
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