Bell PalsyNCT06340009
MIME THERAPY vs MOTOR IMAGERY TECHNIQUE in Bell's Palsy
A study testing mime therapy and motor imagery in people with Bell Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. 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 motor imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Mar 2024to 25 Aug 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
- Age 20-40 years
- Both male and female
- Patients diagnosed with Bell's Palsy
- Paralysis/paresis of all muscle groups of one side of face
Who cannot join
- Patients diagnosed with facial palsy
- Patients with impaired cognition
- Patients diagnosed with other neurological diseases
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Muzaffar Hospital
Sargodha
Mulazam Imran, MS-NMPT*
About this study
Official title: Comparison of Mime Therapy and Motor Imagery Technique on Facial Disability in Bell's Palsy.
Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.
Read the detailed description
While rehabilitation protocols have shown promise in enhancing facial muscle control, reducing disability, and preventing long-term complications, there remains a critical gap in the literature regarding the comparative effectiveness of various rehabilitation techniques. Currently, there is limited empirical evidence to guide healthcare professionals in selecting the most suitable rehabilitation approach for individual patients. The purpose of this study is to address this gap in knowledge by comparing two specific rehabilitation techniques: Mime therapy and Motor imagery technique. Understanding which of these rehabilitation techniques is more effective can significantly influence clinical practice and patient care. By conducting a systematic comparison, this study aims to provide evidence-based recommendations to healthcare professionals in selection of appropriate rehabilitation protocol for Bell's palsy patients.
- Conditions
- Bell Palsy
- Being tested
- mime therapy, motor imagery
- 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
- Facial Massage
- Frowning
- Close eyes
- Smile
- Fish Face
- Eyebrow raising
- Breathing exercise
- Blow cheeks
- Mouth opening and closing.
- Moving lips side to side
- Blow a candle.
- Nasal flaring
- Chewing exercise
- Rinse mouth
- Speaking vowels
- Fill mouth with water
- Fill rubber balloon
- Sucking water with straw
motor imageryOther
- Raising your eyebrows
- Showing angry face
- Closing and opening eyes
- Pouting
- Blowing cheeks
- Smiling
- Nasal flaring
- Blowing candle
- Deviating lips side to side
- Chewing something
- Speaking vowels
| Study group | Role | What they receive |
|---|---|---|
| Mime therapy group | Experimental | Mime therapy focuses on improving facial symmetry and muscle control through self-massage, breathing exercises, eye and lip closure exercises, letter and word exercises, and expression exercises in front of mirror Receives: Other: mime therapy |
| motor imagery group | Active comparator | Motor imagery technique involves mental rehearsal of motor activities, activating similar brain regions as actual movements, which enhances neuroplasticity. Receives: Other: motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann Scale (HBS)
A widely used scale to assess facial nerve dysfunction.Grades facial muscle function from I (normal) to VI (total paralysis). - Higher scores indicate more severe dysfunction.
Measured: week 6
Facial Disability Index (FDI)
A patient-reported outcome measure assessing the impact of facial palsy on daily life.Assesses physical, social, and emotional functioning - Uses a questionnaire. - Higher scores indicate a greater impact on daily life.
Measured: week 6
Sunnybrook Facial Grading System
An assessment tool for evaluating facial muscle function, including static and dynamic aspects.
Measured: week 6
Synkinesis Assessment Questionnaire (SAQ)
An assessment tool specifically designed to evaluate synkinesis- related symptoms. Assesses the presence and severity of synkinesis symptoms during voluntary actions. - Uses a questionnaire. - Higher scores indicate more severe synkinesis-related symptoms.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start22 Mar 2024
- Primary completion22 Aug 2024 (estimated)
- Study completion25 Aug 2024 (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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340009
- Sponsor's protocol ID
- REC/01743
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 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 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mime Therapy and Motor Imagery Technique on Facial Disability in Bell's Palsy.
- ClinicalTrials.gov ID
- NCT06340009
- Acronym / sponsor ID
- REC/01743
- Conditions
- Bell Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 22 Aug 2024 (estimated)
- Study completion
- 25 Aug 2024 (estimated)
- First posted
- 1 Apr 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.
Bell's palsy, characterized by unilateral paralysis/paresis of facial muscles, is a condition with a significant impact on individuals' lives. It was first identified by scientist Sir Charles Bell, and its sudden onset can lead to social, psychological, and emotional distress. Left untreated, Bell's palsy can have long-lasting effects on a patient's quality of life, including loss of facial muscle control, emotional stress, and communication difficulties. Rehabilitation protocols encompass various physical therapy techniques, among which Mime therapy and Motor imagery technique have shown promise.
Detailed description
While rehabilitation protocols have shown promise in enhancing facial muscle control, reducing disability, and preventing long-term complications, there remains a critical gap in the literature regarding the comparative effectiveness of various rehabilitation techniques. Currently, there is limited empirical evidence to guide healthcare professionals in selecting the most suitable rehabilitation approach for individual patients. The purpose of this study is to address this gap in knowledge by comparing two specific rehabilitation techniques: Mime therapy and Motor imagery technique. Understanding which of these rehabilitation techniques is more effective can significantly influence clinical practice and patient care. By conducting a systematic comparison, this study aims to provide evidence-based recommendations to healthcare professionals in selection of appropriate rehabilitation protocol for Bell's palsy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mime therapy group | Experimental | Other: mime therapyMime therapy focuses on improving facial symmetry and muscle control through self-massage, breathing exercises, eye and lip closure exercises, letter and word exercises, and expression exercises in front of mirror |
| motor imagery group | Active comparator | Other: motor imageryMotor imagery technique involves mental rehearsal of motor activities, activating similar brain regions as actual movements, which enhances neuroplasticity. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 20-40 years
- Both male and female
- Patients diagnosed with Bell's Palsy
- Paralysis/paresis of all muscle groups of one side of face
Key exclusion criteria (3 listed)
- Patients diagnosed with facial palsy
- Patients with impaired cognition
- Patients diagnosed with other neurological diseases
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 therapy1. Facial Massage 2. Frowning 3. Close eyes 4. Smile 5. Fish Face 6. Eyebrow raising 7. Breathing exercise 8. Blow cheeks 9. Mouth opening and closing. 10. Moving lips side to side 11. Blow a candle. 12. Nasal flaring 13. Chewing exercise 14. Rinse mouth 15. Speaking vowels 16. Fill mouth with water 17. Fill rubber balloon 18. Sucking water with straw | Other | Mime therapy group |
| motor imagery1. Raising your eyebrows 2. Showing angry face 3. Closing and opening eyes 4. Pouting 5. Blowing cheeks 6. Smiling 7. Nasal flaring 8. Blowing candle 9. Deviating lips side to side 10. Chewing something 11. Speaking vowels | Other | motor imagery group |
Primary outcome
House-Brackmann Scale (HBS)
Time frame: week 6
A widely used scale to assess facial nerve dysfunction.Grades facial muscle function from I (normal) to VI (total paralysis). - Higher scores indicate more severe dysfunction.
Facial Disability Index (FDI)
Time frame: week 6
A patient-reported outcome measure assessing the impact of facial palsy on daily life.Assesses physical, social, and emotional functioning - Uses a questionnaire. - Higher scores indicate a greater impact on daily life.
Sunnybrook Facial Grading System
Time frame: week 6
An assessment tool for evaluating facial muscle function, including static and dynamic aspects.
Synkinesis Assessment Questionnaire (SAQ)
Time frame: week 6
An assessment tool specifically designed to evaluate synkinesis- related symptoms. Assesses the presence and severity of synkinesis symptoms during voluntary actions. - Uses a questionnaire. - Higher scores indicate more severe synkinesis-related symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 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.
Ayesha Afridi, PhD* principal investigator
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 motor imagery 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 4 inclusion and 3 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 1 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mulazam Imran, MS-NMPT* (03236791525, mulazimimran04@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House-Brackmann Scale (HBS) (time frame: week 6). The study lists 4 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 1 Apr 2024.