Bell PalsyNCT06028191
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
A study testing Kabat Technique along with baseline treatment and Kabat Technique and LLLT along with baseline treatment in people with Bell Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Kabat Technique along with baseline treatment and Kabat Technique and LLLT along with baseline treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesPakistan
- Study dates
- 17 Jul 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Previous surgery of facial reconstruction
- Traumatic Brain Injury
- Any other neurological deficit
- Congenital Deformities
- Recurrent Bell's palsy will be excluded
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Allied Hospital
Faisalābad, Punjab Province, 38000
Fatima Tariq, Mphil, 03344255033, fatima.tariq@riphah.edu.pk
- Recruiting
Physiofit
Faisalābad, Punjab Province, 38000
Fatima Tariq, Mphi;, 03344255033, fatima.tariq@riphah.edu.pk
About this study
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
- Conditions
- Bell Palsy
- Being tested
- Kabat Technique along with baseline treatment, Kabat Technique and LLLT along with baseline treatment
- Keywords
- Bell's Palsy, Facial Disability Index, Kabat Technique, Low Level Laser Therapy, Sunnybrook facial grading system
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kabat Technique along with baseline treatmentOther
Also called Group A
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
Kabat Technique and LLLT along with baseline treatmentDevice
Also called Group B
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.
| Study group | Role | What they receive |
|---|---|---|
| Kabat Technique along with baseline treatment | Other | 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. Receives: Other: Kabat Technique along with baseline treatment |
| Kabat Technique and LLLT along with baseline treatment | Experimental | 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 Receives: Device: Kabat Technique and LLLT along with baseline treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunnybrook Facial Grading system
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start17 Jul 2023
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fatima Tariq, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028191
- Sponsor's protocol ID
- REC/RCR & AHS/23/0229
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT06028191
- Acronym / sponsor ID
- REC/RCR & AHS/23/0229
- Conditions
- Bell Palsy
- Keywords
- Bell's Palsy, Facial Disability Index, Kabat Technique, Low Level Laser Therapy, Sunnybrook facial grading system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kabat Technique along with baseline treatment | Other | Other: Kabat Technique along with baseline treatmentKabat 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 | Experimental | Device: Kabat Technique and LLLT along with baseline treatmentKabat 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- Previous surgery of facial reconstruction
- Traumatic Brain Injury
- Any other neurological deficit
- Congenital Deformities
- Recurrent Bell's palsy will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kabat Technique along with baseline treatmentAlso: Group AGroup 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 | Kabat Technique along with baseline treatment |
| Kabat Technique and LLLT along with baseline treatmentAlso: Group BGroup 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. | Device | Kabat Technique and LLLT along with baseline treatment |
Primary outcome
Sunnybrook Facial Grading system
Time frame: 6 weeks
Sunnybrook facial grading system was used to quantify the symmetry of voluntary and resting muscles
1 secondary outcome
Facial disability index
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Bell Palsy
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Combined Effects of Proprioceptive Neuromuscular Facilitation (PNF) and Neural Mobilization on Improving Facial Symmetry in Patients With Bells Palsy
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Electroacupuncture With Two Pulse Patterns for Bell's Palsy Using Surface Electromyography Evaluation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatima Tariq, Mphil principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kabat Technique along with baseline treatment and Kabat Technique and LLLT along with baseline treatment in people with Bell Palsy, run by Riphah International University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatima Tariq, Mphil (03344255033, fatima.tariq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sunnybrook Facial Grading system (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.