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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06029855
Other study ID # REC-UOL-406-05-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2023
Est. completion date October 15, 2023

Study information

Verified date September 2023
Source University of Lahore
Contact Ayesha Amjad, MS
Phone +923054645864
Email ayeshaamjad056@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 85
Est. completion date October 15, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: 1. Age group 25-50 years. 2. Both male and female. 3. Unilateral bell's paralysis. 4. Not congenital in origin. 5. Sub-acute and chronic cases. Exclusion Criteria: 1. Other neurological deficits include epilepsy and Alzheimer's disease. 2. Traumatic onset. 3. Surgical reconstruction (nerve or muscle reconstruction). 4. Mental and psychological disorders i.e., schizophrenia, bipolar disorders. 5. Skin diseases (eczema, urticarial) as electrical stimulation may affect the results. 6. Any contraindications for massage like sunburn, bruising, or cuts.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Kabat Therapy
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.
Mime Therapy
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.

Locations

Country Name City State
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. It will be assessed at baseline, at the third week and at six week.
Primary 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. Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
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