- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06028191
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
Study Overview
Status
Conditions
Detailed Description
Bell's palsy is an acute condition which occurs by the damage of 7th cranial nerve along its course at the level which is distal to Pons. Basically it is an idiopathic facial condition.
The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes equally. This study aims to see combined effects of Low Level Laser Therapy and Kabat technique in the treatment of Bell's palsy.
Synkinesis, which is described as an involuntary movement in one part of the face produced during voluntary movement in another region of the face, is a problematic Bell's palsy sequel. The mechanism behind the formation of synkinesis is unknown. According to the predominant idea, damaged axons regenerate abnormally, innervating facial muscles that weren't originally innervated. The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes equally.
Kabat Technique is neurorehabilitation technique that uses diagonal and spiral patterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator.
For all BP patients, including those who are unable to take corticosteroids due to diabetes or hypertension, laser therapy offers a non-invasive, painless means of treatment. However, just a few researches have examined the effectiveness of low- dose laser therapy in BP patients.
Low Level Laser Therapy has the potential to promote nerve regeneration, reduce inflammation, and accelerate tissue healing in the affected facial nerve. On the other hand, the Kabat technique focuses on restoring neuromuscular control and improving muscle function. By combining Low Level Laser Therapy and the Kabat technique, a synergistic effect may be achieved, maximizing the potential benefits of both interventions. Therefore, this study aims to determine the specific parameters and protocols for the combined use of Low Level Laser Therapy and the Kabat technique in Bell's palsy
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fatima Tariq, Mphil
- Phone Number: 03344255033
- Email: fatima.tariq@riphah.edu.pk
Study Locations
-
-
Punjab
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Faisalābad, Punjab, Pakistan, 38000
- Recruiting
- Allied Hospital
-
Contact:
- Fatima Tariq, Mphil
- Phone Number: 03344255033
- Email: fatima.tariq@riphah.edu.pk
-
Faisalābad, Punjab, Pakistan, 38000
- Recruiting
- PhysioFit
-
Contact:
- Fatima Tariq, Mphi;
- Phone Number: 03344255033
- Email: fatima.tariq@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-40
- Both genders will be included
- Unilateral Facial paralysis/paresis
- Patients presented within onset of 12 days - 3 weeks (sub-acute Bell's Palsy)
Exclusion Criteria:
- Previous surgery of facial reconstruction
- Traumatic Brain Injury
- Any other neurological deficit
- Congenital Deformities
- Recurrent Bell's palsy will be excluded
Study Plan
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 |
---|---|
Other: Kabat Technique along with baseline treatment
Kabat technique will be performed for 15 min along with baseline treatment will be given to Group A. They will have 45 min-1 hour session thrice a week in duration of six weeks.
|
Group A will receive Kabat Technique along with baseline treatment. Electrical muscle stimulation for 15 min which includes faradic current to the facial nerve trunks given by DL-2 electro pulse stimulator, Effleurage and Kneading for 5 min and resistive exercise for 5 min and facial expression exercises for 5 min, which included eye closure, eyebrow raise, frown, smile, snarl, pucker and pout as baseline treatment. Kabat Technique is neurorehabilitation technique that uses diagonal and spiralpatterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator
Other Names:
|
Experimental: Kabat Technique and LLLT along with baseline treatment
Kabat technique will be performed for 15 min and LLLT will be performed for 10 min to eight points of the effected side for 2 min at each point along with baseline treatment.
They will have 45 min-1 hour session thrice a week in duration of six weeks
|
Group B will receive Kabat Technique and LLLT along with baselinetreatment.
Kabat technique is same as mentioned in group A. Laser treatment will be administered to eight points of the affected side for 2 min at each point at a wavelength of 830 nm, output power of 100 Mw, and frequency of 1 KHz.
Endo laser 422 is the model name and number of device which will be used in this study to administered low level laser therapy.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sunnybrook Facial Grading system
Time Frame: 6 weeks
|
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Facial disability index
Time Frame: 6 weeks
|
it has two components.
The physical function subscale detects problems in drinking, speaking eating, lacrimation, and oral hygiene.
The social/well-being function subscale detects subjective irritation, perception of anxiety, and isolation; problems in sleeping; and limitations in social participation.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fatima Tariq, Mphil, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/23/0229
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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