Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
1 other identifier
interventional
36
1 country
2
Brief Summary
The objective of this current study is to determine the combined effects of Low-Level Laser Therapy (LLLT) and the Kabat technique on quality of life, synkinetic movements and functional outcome in patients of Bell's palsy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 17, 2023
CompletedFirst Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedSeptember 8, 2023
August 1, 2023
3 months
August 31, 2023
August 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sunnybrook Facial Grading system
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
6 weeks
Secondary Outcomes (1)
Facial disability index
6 weeks
Study Arms (2)
Kabat Technique along with baseline treatment
OTHERKabat 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.
Kabat Technique and LLLT along with baseline treatment
EXPERIMENTALKabat 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
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Previous surgery of facial reconstruction
- Traumatic Brain Injury
- Any other neurological deficit
- Congenital Deformities
- Recurrent Bell's palsy will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Allied Hospital
Faisalābad, Punjab Province, 38000, Pakistan
Physiofit
Faisalābad, Punjab Province, 38000, Pakistan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatima Tariq, Mphil
Riphah International University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 8, 2023
Study Start
July 17, 2023
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
September 8, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share