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Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy

Primary Purpose

Bell Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kabat Therapy
Mime Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Bell Palsy, Kabat Rehabilitation, Mime Therapy

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Kabat Therapy

Mime Therapy

Arm Description

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.

Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.

Outcomes

Primary Outcome Measures

Change in Synkinesis
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.
Level of Facial Disability
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2023
Last Updated
September 12, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT06029855
Brief Title
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
Official Title
Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell Palsy, Kabat Rehabilitation, Mime Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kabat Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mime Therapy
Arm Type
Experimental
Arm Description
Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.
Intervention Type
Other
Intervention Name(s)
Kabat Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Mime Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Synkinesis
Description
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.
Time Frame
It will be assessed at baseline, at the third week and at six week.
Title
Level of Facial Disability
Description
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.
Time Frame
Change in functional status will be measured at the baseline, at 3rd week and at 6th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Amjad, MS
Phone
+923054645864
Email
ayeshaamjad056@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Jamil, M.Phil
Phone
+923244481031
Email
ayeshabutt031@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq Dr Ahmed, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
5400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Amjad, MS
Phone
+923054645864
Email
ayeshaamjad056@gmail.com
First Name & Middle Initial & Last Name & Degree
Ayesha Jamil, M.Phil
Phone
+923244481031
Email
ayesha.jamil@uipt.uol.edu.pk
First Name & Middle Initial & Last Name & Degree
Ayesha Amjad, MS

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Immediately after publication

Learn more about this trial

Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy

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