Bell PalsyNCT06029855
Kabat Rehabilitation Versus Mime Therapy on Facial Disability and Synkinesis in Patients of Bell's Palsy
A study testing Kabat Therapy and Mime Therapy in people with Bell Palsy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Kabat Therapy and Mime Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2023to 15 Oct 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 25-50 years.
- Both male and female.
- Unilateral bell's paralysis.
- Not congenital in origin.
- Sub-acute and chronic cases.
Who cannot join
- Other neurological deficits include epilepsy and Alzheimer's disease.
- Traumatic onset.
- Surgical reconstruction (nerve or muscle reconstruction).
- Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
- Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
- Any contraindications for massage like sunburn, bruising, or cuts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves.
Read the detailed description
Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern of movement through facilitation, inhibition, and resistance of a group of muscles. It increases the functioning and power of facial muscles while Mime therapy results in immediate improvement of function and integrity of facial muscles. It also mitigates synkinesis in Bell's palsy. Both techniques are easy to apply. They are clinically important techniques that are easily understood by patients.
- Conditions
- Bell Palsy
- Being tested
- Kabat Therapy, Mime Therapy
- Keywords
- Bell Palsy, Kabat Rehabilitation, Mime Therapy
- 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 TherapyOther
The participants of group A will receive Kabat Rehabilitation with routine physical therapy. The protocol will be given to the participants for three sessions/week for six weeks. Each session will be of 30 minutes.
Mime TherapyOther
The participants of group B will receive Mime Therapy in addition to routine physical therapy. The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days. Each session will be of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Kabat Therapy | Active comparator | Kabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance. After 6th week, resting and voluntary symmetries were recorded. Receives: Other: Kabat Therapy |
| Mime Therapy | Experimental | Mime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties. Receives: Other: Mime Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Synkinesis
Synkinesis will be accessed through the "House-Brackmann Scale". It is classified as a universal scale. This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.
Measured: It will be assessed at baseline, at the third week and at six week.
Level of Facial Disability
The level of Facial disability will be measured through the "Facial Disability Index Scale". This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration). It uses a hundred-point scale with a higher score indicating less impairment. 24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.
Measured: Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
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 start1 May 2023
- Primary completion30 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashfaq Dr Ahmed, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06029855
- Sponsor's protocol ID
- REC-UOL-406-05-2023
- Status last verified
- Jan 2025
- First submitted
- 1 Sep 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Amjad A, Jamil A, Fatima N, Javaid HB, Zahid H. Effects of Kabat rehabilitation versus mime therapy on facial disability and synkinesis in patients of Bell's palsy. J Pak Med Assoc. 2024 Nov;74(11):1927-1931. doi: 10.47391/JPMA.11247.
PubMed 39548608
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Kabat Rehabilitation Versus Mime Therapy On Facial Disability And Synkinesis In Patients Of Bell's Palsy
- ClinicalTrials.gov ID
- NCT06029855
- Acronym / sponsor ID
- REC-UOL-406-05-2023
- Conditions
- Bell Palsy
- Keywords
- Bell Palsy, Kabat Rehabilitation, Mime Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- 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.
Bell's palsy, also called idiopathic facial paralysis, is a common cause of unilateral facial paralysis. It is one of the most common neurological disorders of the cranial nerves.
Detailed description
Bell's palsy is an alarming condition of rapid onset, which paralyzes half of the facial muscles. Kabat rehabilitation is a manual resistance technique that promotes a basic pattern of movement through facilitation, inhibition, and resistance of a group of muscles. It increases the functioning and power of facial muscles while Mime therapy results in immediate improvement of function and integrity of facial muscles. It also mitigates synkinesis in Bell's palsy. Both techniques are easy to apply. They are clinically important techniques that are easily understood by patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kabat Therapy | Active comparator | Other: Kabat TherapyKabat exercises primarily assist functional response in defective muscles through the general structure of muscles experiencing resistance. After 6th week, resting and voluntary symmetries were recorded. |
| Mime Therapy | Experimental | Other: Mime TherapyMime therapy utilizes emotional input to access better movement patterns. It is beneficial as it improves circulation and maintains muscle properties. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group 25-50 years.
- Both male and female.
- Unilateral bell's paralysis.
- Not congenital in origin.
- Sub-acute and chronic cases.
Key exclusion criteria (6 listed)
- Other neurological deficits include epilepsy and Alzheimer's disease.
- Traumatic onset.
- Surgical reconstruction (nerve or muscle reconstruction).
- Mental and psychological disorders i.e., schizophrenia, bipolar disorders.
- Skin diseases (eczema, urticarial) as electrical stimulation may affect the results.
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 TherapyThe participants of group A will receive Kabat Rehabilitation with routine physical therapy. The protocol will be given to the participants for three sessions/week for six weeks. Each session will be of 30 minutes. | Other | Kabat Therapy |
| Mime TherapyThe participants of group B will receive Mime Therapy in addition to routine physical therapy. The protocol will be given to the participants once a week for six weeks, while physical therapy will be given on alternate days. Each session will be of 30 minutes. | Other | Mime Therapy |
Primary outcome
Change in Synkinesis
Time frame: It will be assessed at baseline, at the third week and at six week.
Synkinesis will be accessed through the "House-Brackmann Scale". It is classified as a universal scale. This scale analyses the symmetry, synkinesis, stiffness, and global mobility of the face. It is divided into six categories (normal, mild dysfunction, moderate dysfunction, moderately severe dysfunction, severe dysfunction, and total paralysis) and is a 0-6-point scale with 6 representing total paralysis.
Level of Facial Disability
Time frame: Change in functional status will be measured at the baseline, at 3rd week and at 6th week.
The level of Facial disability will be measured through the "Facial Disability Index Scale". This scale has ten items that evaluate the patient's physical and social aspects (mastication, deglutition, communication, labial mobility, emotional alterations, and social integration). It uses a hundred-point scale with a higher score indicating less impairment. 24 Minimum score for physical functioning: 0, Maximum score for physical functioning: 25, Minimum score for social and well-being: 5, Maximum score for social and well-being.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 39548608Amjad A, Jamil A, Fatima N, Javaid HB, Zahid H. Effects of Kabat rehabilitation versus mime therapy on facial disability and synkinesis in patients of Bell's palsy. J Pak Med Assoc. 2024 Nov;74(11):1927-1931. doi: 10.47391/JPMA.11247.
- Individual participant dataSharing planned: Yes
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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.
Ashfaq Dr Ahmed, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kabat Therapy and Mime Therapy in people with Bell Palsy, run by University of Lahore at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Synkinesis (time frame: It will be assessed at baseline, at the third week and at six week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06029855, which also lists 1 linked publication.
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 28 Mar 2025.