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RecruitingNCT06028191Updated Sep 8, 2023

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

An interventional study of Kabat Technique along with baseline treatment and Kabat Technique and LLLT along with baseline treatment in Bell Palsy, sponsored by Riphah International University. Recruiting at 2 sites in Pakistan. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years 1 month ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Bell Palsy

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Keywords

  • Bell's Palsy
  • Facial Disability Index
  • Kabat Technique
  • Low Level Laser Therapy
  • Sunnybrook facial grading system
03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 36 is below the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Previous surgery of facial reconstruction
  • Traumatic Brain Injury
  • Any other neurological deficit
  • Congenital Deformities
  • Recurrent Bell's palsy will be excluded
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • 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.

    Other: Kabat Technique along with baseline treatment

  • 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

    Device: Kabat Technique and LLLT along with baseline treatment

Interventions

  • OtherKabat Technique along with baseline treatment

    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

    Also known as: Group A

  • DeviceKabat Technique and LLLT along with baseline treatment

    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.

    Also known as: Group B

06

What researchers measure

Primary outcomes

  1. Sunnybrook Facial Grading system

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

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: 6 weeks

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06028191
Responsible party
Sponsor
First posted
Sep 8, 2023
Start date
Jul 17, 2023
Primary completion
Oct 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Sep 8, 2023

Study contacts

Fatima Tariq, Mphil
Contact
fatima.tariq@riphah.edu.pk
03344255033
Fatima Tariq, Mphil
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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