Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
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ClinicalTrials.gov Identifier: NCT06029855 |
Recruitment Status :
Recruiting
First Posted : September 8, 2023
Last Update Posted : September 13, 2023
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Condition or disease | Intervention/treatment | Phase |
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Bell Palsy | Other: Kabat Therapy Other: Mime Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy |
Actual Study Start Date : | May 1, 2023 |
Estimated Primary Completion Date : | September 30, 2023 |
Estimated Study Completion Date : | October 15, 2023 |
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.
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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. |
Experimental: Mime Therapy
Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties.
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Other: 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. |
- 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.
- 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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Ages Eligible for Study: | 25 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06029855
Contact: Ayesha Amjad, MS | +923054645864 | ayeshaamjad056@gmail.com | |
Contact: Ayesha Jamil, M.Phil | +923244481031 | ayeshabutt031@gmail.com |
Pakistan | |
The University of Lahore | Recruiting |
Lahore, Punjab, Pakistan, 5400 | |
Contact: Ayesha Amjad, MS +923054645864 ayeshaamjad056@gmail.com | |
Contact: Ayesha Jamil, M.Phil +923244481031 ayesha.jamil@uipt.uol.edu.pk | |
Principal Investigator: Ayesha Amjad, MS |
Study Chair: | Ashfaq Dr Ahmed, PhD | The University of Lahore |
Responsible Party: | University of Lahore |
ClinicalTrials.gov Identifier: | NCT06029855 |
Other Study ID Numbers: |
REC-UOL-406-05-2023 |
First Posted: | September 8, 2023 Key Record Dates |
Last Update Posted: | September 13, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol |
Time Frame: | Immediately after publication |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bell Palsy Kabat Rehabilitation Mime Therapy |
Bell Palsy Facial Paralysis Paralysis Synkinesis Neurologic Manifestations Nervous System Diseases Herpesviridae Infections DNA Virus Infections |
Virus Diseases Infections Mouth Diseases Stomatognathic Diseases Facial Nerve Diseases Cranial Nerve Diseases Dyskinesias |