Bell PalsyNCT06308250
Comparative Effects of Mime Therapy and Action Observation Therapy in Bell's Palsy
A study testing MIME THERAPY and ACTION OBSERVATION THERAPY in people with Bell Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- MIME THERAPY and ACTION OBSERVATION THERAPY
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 10 Jul 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bell's Palsy with acute onset of 1-3 weeks.
- Unilateral loss of facial weakness.
- Patients with intact taste sensation.
- Bell's Palsy of House Brackmann grade 3 and 4.
- Idiopathic Bell's Palsy.
Who cannot join
- History of facial palsy recurrence.
- Stroke associated Bells palsy.
- History of pregnancy
- Subjects with any disability, fracture, or tumor.
- History of facial surgery.
- Subject having skin allergy on face.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54660
About this study
Official title: Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy
The aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.
Read the detailed description
This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.
Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.
- Conditions
- Bell Palsy
- Being tested
- MIME THERAPY, ACTION OBSERVATION THERAPY
- Keywords
- Bell Palsy, Breathing exercise, Comparative, MIME Protocol, Randomized clinical trial
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIME THERAPYOther
Mime therapy consist of:
Self massage: patients will be taught to massage their face and neck daily for about 10 minutes which includes effleurage and kneading of both sides of face.
Breathing exercises: patient will be taught to recognize tension and feel the difference between tension and relaxation in facial musculature for 5 minutes. Expiration exercises will be used to induce relaxation.
Articulation: vowels such as a,e,i,o,u and consonants such as p and b will be used to teach position of the lips for 5 minutes.
Facial expression exercises: forehead wrinkle, smiling, eye closure, frowning, disgust, surprise, anger, sadness will be performed for 10 minutes
ACTION OBSERVATION THERAPYOther
Function of each of the muscle is observed for 3 minutes and then executed for 2 minutes.
Frontalis (Raising eyebrows and forehead wrinkling). Corrugator Supercili (Moving the eyebrow down and inward toward the nose and inner eye).
Orbicularis oculi (Closing the eyelids). Buccinator (Blowing air in and out of the mouth). Zygomaticus major (Smiling). Orbicularis oris (Lip pursing or puckering).
| Study group | Role | What they receive |
|---|---|---|
| GROUP A ( MIME THERAPY) | Experimental | Group A will receive mime therapy of 30 minutes with short resting intervals. Treatment will be given 5 times per week for 6 weeks. Mime therapy consist of:
1. Self massage of 10 minutes,
2. Breathing and relaxation exercises of 5 minutes,
3. Articulation of 5 minutes and
4. Facial expression exercises of 10 minutes. Receives: Other: MIME THERAPY |
| GROUP B (ACTION OBSERVATION THERAPY) | Experimental | Group B will receive action observation therapy of 30 minutes with short resting interval. The treatment will be given 5 times per week for 6 weeks.
During the presentation of a video clip, patients sit relaxed in front of the computer screen while observing it.
After observing a motor act for 3 min (observation phase) patients are required to imitate what they observed for 2 min (execution phase). Receives: Other: ACTION OBSERVATION THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunny Brook Facial Grading System
The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as [4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis] with 100 representing normal facial symmetry.
Measured: 6th week
Facial Disability Index
it is used to assess the quality of life in patients with bell's palsy. It also helps to measure the difficulties of the face in activities of daily living. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The individual subscales are scored out of a total of 100 where the highest score is the best result.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start25 Feb 2024
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhmmad Kashif, PhD-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308250
- Sponsor's protocol ID
- REC/RCR&AHS/23/0294
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 17 Jul 2024
- 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 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Mime Therapy and Action Observation Therapy on Facial Symmetry and Quality of Life in Bell's Palsy
- ClinicalTrials.gov ID
- NCT06308250
- Acronym / sponsor ID
- REC/RCR&AHS/23/0294
- Conditions
- Bell Palsy
- Keywords
- Bell Palsy, Breathing exercise, Comparative, MIME Protocol, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 13 Mar 2024 (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 aim of this study is to determine comparative effects of mime therapy and action observation therapy on facial symmetry and quality of life in Bell's palsy. Bell's palsy is characterized as an abrupt paralysis of the peripheral facial nerve, typically without a known cause. Mime Therapy is a performing technique that helps patients regain the ability to use their face muscles. Action observation therapy is novel rehabilitation approach exploiting this mirror mechanism.
Detailed description
This randomized clinical trial will be conducted at Sir Ganga Ram Hospital in 7 months. 62 participants with Bell's palsy will be included as per sample size calculation through convenience sampling technique. Participants which meet inclusion criteria will be randomly allocated using online randomization tool into two groups. Group A will receive Mime therapy for 30 minutes with short resting interval and Group B will receive action observation therapy for 30 minutes. Each group will receive treatment session of 5 days per week for 6 weeks.
Facial symmetry will be measured using the 13-item Sunny Brook facial Grading System, Facial disability index will be used to assess the quality of life and The House-Brackmann Facial Nerve Grading System will be used to characterize the degree of facial paralysis. The data will be analyzed using SPSS version 24 for Windows software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A ( MIME THERAPY) | Experimental | Other: MIME THERAPYGroup A will receive mime therapy of 30 minutes with short resting intervals. Treatment will be given 5 times per week for 6 weeks. Mime therapy consist of: 1. Self massage of 10 minutes, 2. Breathing and relaxation exercises of 5 minutes, 3. Articulation of 5 minutes and 4. Facial expression exercises of 10 minutes. |
| GROUP B (ACTION OBSERVATION THERAPY) | Experimental | Other: ACTION OBSERVATION THERAPYGroup B will receive action observation therapy of 30 minutes with short resting interval. The treatment will be given 5 times per week for 6 weeks. During the presentation of a video clip, patients sit relaxed in front of the computer screen while observing it. After observing a motor act for 3 min (observation phase) patients are required to imitate what they observed for 2 min (execution phase). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Bell's Palsy with acute onset of 1-3 weeks.
- Unilateral loss of facial weakness.
- Patients with intact taste sensation.
- Bell's Palsy of House Brackmann grade 3 and 4.
- Idiopathic Bell's Palsy.
Key exclusion criteria (6 listed)
- History of facial palsy recurrence.
- Stroke associated Bells palsy.
- History of pregnancy
- Subjects with any disability, fracture, or tumor.
- History of facial surgery.
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 |
|---|---|---|
| MIME THERAPYMime therapy consist of: Self massage: patients will be taught to massage their face and neck daily for about 10 minutes which includes effleurage and kneading of both sides of face. Breathing exercises: patient will be taught to recognize tension and feel the difference between tension and relaxation in facial musculature for 5 minutes. Expiration exercises will be used to induce relaxation. Articulation: vowels such as a,e,i,o,u and consonants such as p and b will be used to teach position of the lips for 5 minutes. Facial expression exercises: forehead wrinkle, smiling, eye closure, frowning, disgust, surprise, anger, sadness will be performed for 10 minutes | Other | GROUP A ( MIME THERAPY) |
| ACTION OBSERVATION THERAPYFunction of each of the muscle is observed for 3 minutes and then executed for 2 minutes. Frontalis (Raising eyebrows and forehead wrinkling). Corrugator Supercili (Moving the eyebrow down and inward toward the nose and inner eye). Orbicularis oculi (Closing the eyelids). Buccinator (Blowing air in and out of the mouth). Zygomaticus major (Smiling). Orbicularis oris (Lip pursing or puckering). | Other | GROUP B (ACTION OBSERVATION THERAPY) |
Primary outcome
Sunny Brook Facial Grading System
Time frame: 6th week
The system includes three components: resting symmetry, the symmetry of voluntary movements, and synkinesis. A composite facial symmetry score is calculated as [4 × symmetry of voluntary movement - 5 × resting asymmetry + 1 × synkinesis] with 100 representing normal facial symmetry.
Facial Disability Index
Time frame: 6th week
it is used to assess the quality of life in patients with bell's palsy. It also helps to measure the difficulties of the face in activities of daily living. It represents the relationship between impairments, disability, and psychosocial status and also focuses on the disability of individuals with disorders of the facial motor system. The individual subscales are scored out of a total of 100 where the highest score is the best result.
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 17 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Muhmmad Kashif, PhD-PT study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIME THERAPY and ACTION OBSERVATION THERAPY in people with Bell Palsy, run by Riphah International University 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 17 Jul 2024. 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?
Sunny Brook Facial Grading System (time frame: 6th 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?
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 17 Jul 2024.