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Comparative effects of rhythmic Initiation and rhythmic stabilization in patient with bell's palsy

Protocol summary

Study aim
This study will guide the researchers to do more work on rhythmic initiation and rhythmic stabilization. It will guide the researchers to explore the effects of rhythmic initiation and rhythmic stabilization and decreases the facial weakness and increases the muscular movement. It will help them to identify the treatment techniques to improve the facial muscles, symmetry and its movement.
Design
Randomized clinical trials with 32 participants of bells palsy and included by random allocation. Parallel group with blinded outcome assessment
Settings and conduct
Mujahid hospital, Shahid Ahmed heera's health clinic, Allied hospital, Rubina Memorial, Faisal Hospital.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Both gender, Age of 20-40 years, Acute onset 1-3 weeks, Bell’s palsy diagnosed with House Brackmann grading index Grade3,4, Steroids intake, Facial asymmetry with facial disability index. Exclusion Criteria: Patient having psychological problems, Patient having Neurological deficits, Patient having Stroke, Patient having Multiple Sclerosis, Facial palsy , Patient having Bilateral facial paralysis.
Intervention groups
Patient was divided into two groups, group A and group B. In group A, Rhythmic initiation along with kabat patterns was applied on patient 12 sessions over 4 weeks, 3 times/weeks, 10-15 min and other group is group B, Rhythmic stabilization along with kabat patterns was applied on patient 12 sessions over 4 weeks, 3 times /weeks, 10-15min. Pre and post assessment were taken before and after intervention, then compare the readings to check the effect of both techniques and its effects of neuroplasticity on bell’s palsy. After 1 month follow up was taken.
Main outcome variables
Facial asymmetry and muscular weakness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230708058712N1
Registration date: 2023-09-18, 1402/06/27
Registration timing: registered_while_recruiting

Last update: 2023-09-18, 1402/06/27
Update count: 0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Maheen Fatima
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8712728
Email address
maheenfatima208@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-15, 1402/06/24
Expected recruitment end date
2023-10-15, 1402/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of rhythmic Initiation and rhythmic stabilization in patient with bell's palsy
Public title
Comparative effects of rhythmic Initiation and rhythmic stabilization in patient with bell's palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acute onset 1-3 weeks Steroids intake Both gender 20-40 years included Bells palsy diagnosed with house brackman grading index Facial asymmetry diagnosed with facial disability index
Exclusion criteria:
Patient having psychological problems Patient having neurological deficits Stroke patient Multiple sclerosis Facial palsy Patient having Bilateral bells palsy
Age
From 20 years old to 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
According to inclusion and exclusion criteria, all enrolled participants would be allocated into two groups randomly by lottery method. The randomization process in this study will follow a simple randomization method at the individual level. Unit of randomization would be individual participants, that means each individual participants would be assigned into two groups that are rhythmic Initiation and rhythmic stabilization groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The current study will be single blinded, as the outcome acessor should be kept blinded which reduces the risk of biasnes. Outcome acessor should have no information about the recruitment of participants. As they would not know which participants belongs to group A and group B, which reduces the risk of biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Randomized clinical trials and purposive sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics review committee
Street address
University Avenue, Faisal town Canal road, Faisalabad.
City
Faisalabad
Postal code
38000
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
TUF/Addl Reg/SB/388

Health conditions studied

1

Description of health condition studied
Bells palsy is the lower motor neuron lesion which is the injury of CN 7 that is facial nerve. It is caused by viral infection and symptoms like drooping of eyelid, paralysis of one side of face, excessive tearing, difficulty in eating and slurred speech.
ICD-10 code
G51. 0
ICD-10 code description
Bells palsy

Primary outcomes

1

Description
Muscular weakness and facial asymmetry
Timepoint
Before the intervention, 4th week post treatment and 1 month follow up
Method of measurement
House brackmann grading index measure the muscular weakness and facial disability index measure the facial asymmetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: group A receive rhythmic initiation with kabat patterns and other intervention group: group B receive rhythmic stabilization with kabat patterns
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Madina teaching hospital, Allied hospital, Mujahid hospital, Faisal hospital, Rubina Memorial, Shahi
Full name of responsible person
Maheen Fatima
Street address
Jarhanwala Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
Email
maheenfatima208@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Nisar Fatima
Street address
Faisal town Canal road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 331 8711448
Email
nisar.fatima@gmail.com
Grant name
No
Grant code / Reference number
No
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self funding
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Nisar Fatima
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0098 41 8868326
Email
nisar.fatima@tuf.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Dr Nisar Fatima
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Sargodha road, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
0098 41 8868326
Email
nisar.fatima@tuf.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Maheen Fatima
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
P-167 Al Najaf colony Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 8712728
Fax
Email
maheenfatima208@gmail.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
Yes - There is a plan to make this available
Title and more details about the data/document
Comparative effects of rhythmic initiation and rhythmic stabilization in patient with Bell's palsy
When the data will become available and for how long
January 2023 to April 2023
To whom data/document is available
People who suffered the bells palsy received the treatment
Under which criteria data/document could be used
Aged 20-40 years of both gender
From where data/document is obtainable
Clinic and hospital
What processes are involved for a request to access data/document
Through questionnaire which was done during intervention
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