- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06029855
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
September 12, 2023 updated by: University of Lahore
Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis.
It is one of the most common neurological disorders of the cranial nerves.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial muscles.
Kabat rehabilitation is a manual resistance technique that promotes a basic pattern of movement through facilitation, inhibition, and resistance of a group of muscles.
It increases the functioning and power of facial muscles while Mime therapy results in immediate improvement of function and integrity of facial muscles.
It also mitigates synkinesis in Bell's palsy.
Both techniques are easy to apply.
They are clinically important techniques that are easily understood by patients.
Study Type
Interventional
Enrollment (Estimated)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayesha Jamil, M.Phil
- Phone Number: +923244481031
- Email: ayeshabutt031@gmail.com
Study Contact Backup
- Name: Ayesha Amjad, MS
- Phone Number: +923054645864
- Email: ayeshaamjad056@gmail.com
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 5400
- Recruiting
- The University of Lahore
-
Contact:
- Ayesha Jamil, M.Phil
- Phone Number: +923244481031
- Email: ayesha.jamil@uipt.uol.edu.pk
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Contact:
- Ayesha Amjad, MS
- Phone Number: +923054645864
- Email: ayeshaamjad056@gmail.com
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Principal Investigator:
- Ayesha Amjad, MS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age group 25-50 years.
- Both male and female.
- Unilateral bell's paralysis.
- Not congenital in origin.
- Sub-acute and chronic cases.
Exclusion Criteria:
- Other neurological deficits include epilepsy and Alzheimer's disease.
- Traumatic onset.
- Surgical reconstruction (nerve or muscle reconstruction).
- Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
- Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
- Any contraindications for massage like sunburn, bruising, or cuts.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Kabat Therapy
Kabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance.
After 6th week, resting and voluntary symmetries were recorded.
|
The participants of group A will receive Kabat Rehabilitation with routine physical therapy.
The protocol will be given to the participants for three sessions/week for six weeks.
Each session will be of 30 minutes.
|
Experimental: Mime Therapy
Mime therapy utilizes emotional input to access better movement patterns.
It is beneficial as it improves circulation and maintains muscle properties.
|
The participants of group B will receive Mime Therapy in addition to routine physical therapy.
The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days.
Each session will be of 30 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Synkinesis
Time Frame: It will be assessed at baseline, at the third week and at six week.
|
Synkinesis will be accessed through the "House-Brackmann Scale".
It is classified as a universal scale.
This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face.
It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.
|
It will be assessed at baseline, at the third week and at six week.
|
Level of Facial Disability
Time Frame: Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
|
The level of Facial disability will be measured through the "Facial Disability Index Scale".
This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration).
It uses a hundred-point scale with a higher score indicating less impairment.
24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.
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Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ashfaq Dr Ahmed, PhD, The University of Lahore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
September 30, 2023
Study Completion (Estimated)
October 15, 2023
Study Registration Dates
First Submitted
September 1, 2023
First Submitted That Met QC Criteria
September 1, 2023
First Posted (Actual)
September 8, 2023
Study Record Updates
Last Update Posted (Actual)
September 13, 2023
Last Update Submitted That Met QC Criteria
September 12, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-UOL-406-05-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
Immediately after publication
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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