Bell PalsyNCT06775717
Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.
A study testing Motor Imagery with conventional Treatment and Mirror therapy with conventional Treatment. in people with Bell Palsy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Motor Imagery with conventional Treatment and Mirror therapy with conventional Treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Oct 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and above.
- Both genders male and female will be included.
- Patients diagnosed with Bell's palsy with relevant diagnostic criteria, including history. (tick bite, erythema migraine, pain), neurological examination including inspection of ear and infection of HIV, Herpes virus.
- Patient having asymmetry in face (Sunnybrook Facial Grading Scale SFGS, use to check asymmetry in both sides of face).
- Appearance of synkinesis on affected side (Synkinesis Assessment Scale)
- Onset of symptoms must be first week.
- Patient having sufficient, physical, and mental ability to understand instructions and cooperate throughout the session.
Who cannot join
- Patients diagnosed with other than Bell's palsy (e.g., facial nerve trauma) (25).
- Patients with severe co-morbidities (e.g., uncontrolled hypertension, diabetes, cardiovascular diseases).
- Patients with significant cognitive impairment or communication difficulties who have undergone previous facial nerve surgery or interventions.
- Patients with severe psychiatric conditions affecting compliance or participation and on psychiatric medications.
- Patients with central nervous system tumor.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Bashir Hospital.
Sialkot, Punjab Province
Sulehri Children Hospital
Sialkot, Punjab Province
About this study
Official title: Comparative Effects of Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and Quality of Life in Bell's Palsy Patients.
Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being.
Participant will be assigned two groups, A and B. All the groups will receive interventions for five days a week for 8 weeks and treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements, data will be collected on SPSS.
Read the detailed description
Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. These symptoms significantly impact facial symmetry and quality of life. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being. The primary objective of this study is to compare the effects of the Mirror therapy and Motor Imagery on facial symmetry, synkinesis and quality of life in patients with Bell's palsy. This randomized clinical trial will be carried in 10 months after the approval of synopsis. Total number of 36 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated randomization method. Group A and Group participants will receive Motor Imagery and Mirror therapy, respectively. All the groups will receive interventions for five days a week for 8 weeks. Total treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements. The data will be analyze using SPSS version 28 for windows. Assessment will be carried out at baseline and four weeks, after discontinuation of treatment.
- Conditions
- Bell Palsy
- Being tested
- Motor Imagery with conventional Treatment, Mirror therapy with conventional Treatment.
- Keywords
- Facial asymmetry, Quality of life, Facial function, Mirror therapy, Motor Imagery
- Medical subject headings
- Bell Palsy, Facial Asymmetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Imagery with conventional TreatmentOther
This treatment will be given 5 sessions a week in 4 consecutive weeks.
Mirror therapy with conventional Treatment.Other
This treatment will be given 5 sessions a week in 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Motor Imagery with conventional Treatment. | Experimental | 21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 weeks. Receives: Other: Motor Imagery with conventional Treatment; Other: Mirror therapy with conventional Treatment. |
| Mirror therapy with conventional Treatment. | Active comparator | 21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 consecutive weeks. Receives: Other: Motor Imagery with conventional Treatment; Other: Mirror therapy with conventional Treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Facial Clinometric Scale:
The FaCE scale is a fascial palsy-related self-assessment QoL questionnaire comprising 15 questions based on a 5-point Likert-scale that evaluates the intensity and frequency of physical and psychosocial impairments in 6 domains of facial function: facial movement, facial comfort, eye comfort, oral function, lacrimal control and social function.
Measured: 4 weeks
Sunnybrook Facial Grading Scale:
Sunnybrook scale is considered the current standard in evaluating outcomes and synkinesis due to its comprehensive scope, ease of use, and rapid results interpretation (27). The Sunnybrook facial grading scale, unlike others, systematically focuses on each subunit of facial movement (eyebrows, eyelids, nasal base, upper lip, and lower lip), while subjects are instructed to make six simple facial expressions.
Measured: 4 weeks
Synkinesis Assessment Scale:
The phenomenon known as synkinesis occurs when there is intentional movement in one or more ipsilateral facial regions but involuntary movement in another area of the face.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Oct 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775717
- Sponsor's protocol ID
- REC\RCR & AHS\24\0252
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castaldo M, Sellitto G, Ruotolo I, Berardi A, Galeoto G. The Use of Mirror Therapy in Peripheral Seventh Nerve Palsy: A Systematic Review. Brain Sci. 2024 May 23;14(6):530. doi: 10.3390/brainsci14060530.
PubMed 38928530Patel H, Landge P, Barot J. A Comparative Study to Analyse the Effect of Motor Imagery and Mirror Book Therapy Versus Mime Therapy for the Recovery in Patients with Acute Bell's Palsy. Int J Sci Res. 2023;12(12):2047-55.
Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.
PubMed 27997734Khanzada K, Ijaz Gondal M, Qamar M, Basharat A, Ahmad W, Ali S. Comparison of efficacy of Kabat rehabilitation and facial exercises along with nerve stimulation in patients with Bell's palsy. BLDE Univ J Heal Sci. 2018;3(1):31.
Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.
PubMed 24189771Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
PubMed 36397921
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and Quality of Life in Bell's Palsy Patients.
- ClinicalTrials.gov ID
- NCT06775717
- Acronym / sponsor ID
- REC\RCR & AHS\24\0252
- Conditions
- Bell Palsy
- Keywords
- Facial asymmetry, Quality of life, Facial function, Mirror therapy, Motor Imagery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 15 Jan 2025 (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 is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being.
Participant will be assigned two groups, A and B. All the groups will receive interventions for five days a week for 8 weeks and treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements, data will be collected on SPSS.
Detailed description
Bell's palsy is a condition that causes sudden weakness in the muscles on one side of the face. The weakness makes half of the face appear to droop, difficulty in closing eyes and synkinesis. These symptoms significantly impact facial symmetry and quality of life. Mirror therapy and Motor imagery have shown promise in improving motor function and overall well-being. The primary objective of this study is to compare the effects of the Mirror therapy and Motor Imagery on facial symmetry, synkinesis and quality of life in patients with Bell's palsy. This randomized clinical trial will be carried in 10 months after the approval of synopsis. Total number of 36 participants meeting the inclusion criteria will be included in this study through a non-probability convenience sampling technique. Participants will be randomly assigned into 2 groups using computer generated randomization method. Group A and Group participants will receive Motor Imagery and Mirror therapy, respectively. All the groups will receive interventions for five days a week for 8 weeks. Total treatment time will be 35 minutes. The outcome measuring scales used will be facial Clinometric Scale (FaCE), Synkinesis Assessment Scale and Sunnybrook facial grading system to assess facial symmetry, synkinesis and facial movements. The data will be analyze using SPSS version 28 for windows. Assessment will be carried out at baseline and four weeks, after discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor Imagery with conventional Treatment. | Experimental | Other: Motor Imagery with conventional Treatment, Other: Mirror therapy with conventional Treatment.21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 weeks. |
| Mirror therapy with conventional Treatment. | Active comparator | Other: Motor Imagery with conventional Treatment, Other: Mirror therapy with conventional Treatment.21 patients will get the mirror therapy. Duration of sessions will be 35 minutes, with 5 sessions a week in 4 consecutive weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years and above.
- Both genders male and female will be included.
- Patients diagnosed with Bell's palsy with relevant diagnostic criteria, including history. (tick bite, erythema migraine, pain), neurological examination including inspection of ear and infection of HIV, Herpes virus.
- Patient having asymmetry in face (Sunnybrook Facial Grading Scale SFGS, use to check asymmetry in both sides of face).
- Appearance of synkinesis on affected side (Synkinesis Assessment Scale)
Key exclusion criteria (5 listed)
- Patients diagnosed with other than Bell's palsy (e.g., facial nerve trauma) (25).
- Patients with severe co-morbidities (e.g., uncontrolled hypertension, diabetes, cardiovascular diseases).
- Patients with significant cognitive impairment or communication difficulties who have undergone previous facial nerve surgery or interventions.
- Patients with severe psychiatric conditions affecting compliance or participation and on psychiatric medications.
- Patients with central nervous system tumor.
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 |
|---|---|---|
| Motor Imagery with conventional TreatmentThis treatment will be given 5 sessions a week in 4 consecutive weeks. | Other | Mirror therapy with conventional Treatment., Motor Imagery with conventional Treatment. |
| Mirror therapy with conventional Treatment.This treatment will be given 5 sessions a week in 4 consecutive weeks. | Other | Mirror therapy with conventional Treatment., Motor Imagery with conventional Treatment. |
Primary outcome
The Facial Clinometric Scale:
Time frame: 4 weeks
The FaCE scale is a fascial palsy-related self-assessment QoL questionnaire comprising 15 questions based on a 5-point Likert-scale that evaluates the intensity and frequency of physical and psychosocial impairments in 6 domains of facial function: facial movement, facial comfort, eye comfort, oral function, lacrimal control and social function.
Sunnybrook Facial Grading Scale:
Time frame: 4 weeks
Sunnybrook scale is considered the current standard in evaluating outcomes and synkinesis due to its comprehensive scope, ease of use, and rapid results interpretation (27). The Sunnybrook facial grading scale, unlike others, systematically focuses on each subunit of facial movement (eyebrows, eyelids, nasal base, upper lip, and lower lip), while subjects are instructed to make six simple facial expressions.
Synkinesis Assessment Scale:
Time frame: 4 weeks
The phenomenon known as synkinesis occurs when there is intentional movement in one or more ipsilateral facial regions but involuntary movement in another area of the face.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 38928530Castaldo M, Sellitto G, Ruotolo I, Berardi A, Galeoto G. The Use of Mirror Therapy in Peripheral Seventh Nerve Palsy: A Systematic Review. Brain Sci. 2024 May 23;14(6):530. doi: 10.3390/brainsci14060530.
- BackgroundPatel H, Landge P, Barot J. A Comparative Study to Analyse the Effect of Motor Imagery and Mirror Book Therapy Versus Mime Therapy for the Recovery in Patients with Acute Bell's Palsy. Int J Sci Res. 2023;12(12):2047-55.
- Background: PubMed 27997734Roh TS, Jung BK, Yun I, Lew DH, Kim YS. Effect of botulinum toxin A on vasoconstriction and sympathetic neurotransmitters in a murine random pattern skin flap model. Wound Repair Regen. 2017 Jan;25(1):75-85. doi: 10.1111/wrr.12501. Epub 2017 Jan 5.
- BackgroundKhanzada K, Ijaz Gondal M, Qamar M, Basharat A, Ahmad W, Ali S. Comparison of efficacy of Kabat rehabilitation and facial exercises along with nerve stimulation in patients with Bell's palsy. BLDE Univ J Heal Sci. 2018;3(1):31.
- Background: PubMed 24189771Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.
- Background: PubMed 36397921Singh A, Deshmukh P. Bell's Palsy: A Review. Cureus. 2022 Oct 11;14(10):e30186. doi: 10.7759/cureus.30186. eCollection 2022 Oct.
- 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.
Sabiha Arshad 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 Motor Imagery with conventional Treatment and Mirror therapy with conventional 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 7 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: enrolling by invitation, as of the sponsor's last update on 15 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
The Facial Clinometric Scale: (time frame: 4 weeks). The study lists 3 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 NCT06775717, which also lists 6 linked publications.
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 15 Jan 2025.