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Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy

Primary Purpose

Bell Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Kabat Technique along with baseline treatment
Kabat Technique and LLLT along with baseline treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy focused on measuring Bell's Palsy, Facial Disability Index, Kabat Technique, Low Level Laser Therapy, Sunnybrook facial grading system

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Allied HospitalRecruiting
  • PhysiofitRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Kabat Technique along with baseline treatment

Kabat Technique and LLLT along with baseline treatment

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Sunnybrook Facial Grading system
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles

Secondary Outcome Measures

Facial disability index
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.

Full Information

First Posted
August 31, 2023
Last Updated
August 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06028191
Brief Title
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
Official Title
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
Keywords
Bell's Palsy, Facial Disability Index, Kabat Technique, Low Level Laser Therapy, Sunnybrook facial grading system

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Kabat Technique along with baseline treatment
Arm Type
Other
Arm Description
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.
Arm Title
Kabat Technique and LLLT along with baseline treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Kabat Technique along with baseline treatment
Other Intervention Name(s)
Group A
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Kabat Technique and LLLT along with baseline treatment
Other Intervention Name(s)
Group B
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sunnybrook Facial Grading system
Description
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Facial disability index
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima Tariq, Mphil
Phone
03344255033
Email
fatima.tariq@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatima Tariq, Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Hospital
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Tariq, Mphil
Phone
03344255033
Email
fatima.tariq@riphah.edu.pk
Facility Name
Physiofit
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatima Tariq, Mphi;
Phone
03344255033
Email
fatima.tariq@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy

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