Facial PalsyNCT04993417
Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients
A study testing Motor imagery technique along with EMS and Mime Therapy along with EMS in people with Facial Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This project was a Randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Facial Palsy
- What is being tested?
- Motor imagery technique along with EMS and Mime Therapy along with EMS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2020to 30 Jun 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral facial palsy more than 6 months
- Age 20-60 years
- House-Brackmann Scale Score ≥3
- Both genders
Who cannot join
- Pregnant women
- Psychological treatment for any psychiatric disorder
- Participants with the history of any tumor
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients; A Randomized Clinical Trial
This project was a Randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. Duration was of 6 months, convenient sampling was done, subjects following eligibility criteria from Imran Idrees Teaching hospital and Idrees Hospital Sialkot, were randomly allocated in two groups via computer generated method, baseline assessment was done, MIT Group received motor imagery technique, 45 min session (3 times a week for 3 months) plus the EMS (10-15 min), while the MT Group received mime therapy 30-45 min session (3 times a week for 3 months) plus the EMS (10-15 min). Outcome measures were collected for both groups at before treatment (T0) and at the end of the treatment i-e after 3 months (T1). The outcome measures were severity of paresis, facial symmetry and intensity of depression measured by using House-Brackmann Scale, Sunnybrook Facial Grading System and Beck Depression Inventory Scale, respectively. Data was analyzed by using SPSS version 24.0.
Read the detailed description
Facial palsy is due to the damage in the facial nerve that supplies the muscles of the face. Peripheral facial nerve paralysis can have various causes, such as Bell's palsy, which is the most common cause. Among secondary cause, tumors and the adverse effects of surgery for tumor pathologies such as, acoustic neuroma and facial nerve schwannoma are the most prevalent. The prognosis for FNP is complete recovery in roughly 80% of cases with Bell's palsy, whereas 15% experiences some type of permanent nerve damage, with the remaining 5% enduring severe sequelae. To this end, FNP should be treated in a multidisciplinary setting, in which physical therapy, psychological and medical or surgical interventions are integrated. The current study has compared the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients. The current study was novel in a way that there is no evidence of superiority of any rehabilitative treatment compared with another in the recovery of FNP, which was clearly determined by the current study.
- Conditions
- Facial Palsy
- Being tested
- Motor imagery technique along with EMS, Mime Therapy along with EMS
- Keywords
- Facial nerve palsy, Mime therapy, Motor imagery technique
- Medical subject headings
- Facial Paralysis, Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imagery technique along with EMSOther
All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. The patients were mentioned to play out the emotional facial appearances for non-verbal correspondence i-e pleasure, misery, interest, appall, dread, irritation and shock. Patients were then requestedto envision himself winking, for instance, envisioning himself in a wonderful and natural social setting, at that point the patient cognitively addresses, with his eyes shut, the movement of decaying the recognized central issues, without creating any specific movement.
Mime Therapy along with EMSOther
All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. Mime treatment incorporates self kneading of face and neck, breathing and relaxation works out, activities to synchronize the two sides and diminish synkinesis and for eye and lip closure per the myofascial way to deal with recovery, letter and word practices and expressive activities.
| Study group | Role | What they receive |
|---|---|---|
| Mime Therapy along with EMS | Experimental | MT Group: Mime Therapy along with EMS Receives: Other: Mime Therapy along with EMS |
| Motor imagery technique along with EMS | Experimental | MIT Group: Motor imagery technique along with EMS Receives: Other: Motor imagery technique along with EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
House-Brackmann Scale (HBS)
House-Brackmann Facial Grading System comprises of six evaluations, where grade 1 addresses normal function and grade VI addresses complete loss of motion. It is quite possibly the most generally utilized scales and has been appeared to have great between rater reliability anyway its affectability to change in facial symmetry is low.
Measured: 12th Week
Secondary outcomes (1)
Sunnybrook Facial Grading System (SFGS)
SunnyBrook Facial Grading System is a 13 item evaluating scale. The framework estimates three segments of facial deviation; resting asymmetry, symmetry of voluntary activities and synkinesis. Resting lopsidedness of the eye, cheek and mouth are all things considered scored from 0 to 4 with 4 being the most uneven. Symmetry of the intentional movements; forehead wrinkle, delicate eye conclusion, open mouth grin, growl and lip pucker, are each scored from 0 to 3 with 3 being the most synkinetic, giving an all out scope of 0 to 15
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start30 Nov 2020
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Facial 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 (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehwish Ikram, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993417
- Sponsor's protocol ID
- REC/Lhr/20/0209 Aysha
- Status last verified
- Aug 2021
- First submitted
- 19 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garro A, Nigrovic LE. Managing Peripheral Facial Palsy. Ann Emerg Med. 2018 May;71(5):618-624. doi: 10.1016/j.annemergmed.2017.08.039. Epub 2017 Oct 27. No abstract available.
PubMed 29110887Robinson MW, Baiungo J. Facial Rehabilitation: Evaluation and Treatment Strategies for the Patient with Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1151-1167. doi: 10.1016/j.otc.2018.07.011. Epub 2018 Sep 24.
PubMed 30262166Codari M, Pucciarelli V, Stangoni F, Zago M, Tarabbia F, Biglioli F, Sforza C. Facial thirds-based evaluation of facial asymmetry using stereophotogrammetric devices: Application to facial palsy subjects. J Craniomaxillofac Surg. 2017 Jan;45(1):76-81. doi: 10.1016/j.jcms.2016.11.003. Epub 2016 Nov 17.
PubMed 27939040Dusseldorp JR, van Veen MM, Mohan S, Hadlock TA. Outcome Tracking in Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1033-1050. doi: 10.1016/j.otc.2018.07.003. Epub 2018 Aug 29.
PubMed 30172554Greene JJ, Guarin DL, Tavares J, Fortier E, Robinson M, Dusseldorp J, Quatela O, Jowett N, Hadlock T. The spectrum of facial palsy: The MEEI facial palsy photo and video standard set. Laryngoscope. 2020 Jan;130(1):32-37. doi: 10.1002/lary.27986. Epub 2019 Apr 25.
PubMed 31021433Monsanto RD, Bittencourt AG, Bobato Neto NJ, Beilke SC, Lorenzetti FT, Salomone R. Treatment and Prognosis of Facial Palsy on Ramsay Hunt Syndrome: Results Based on a Review of the Literature. Int Arch Otorhinolaryngol. 2016 Oct;20(4):394-400. doi: 10.1055/s-0036-1584267. Epub 2016 May 30.
PubMed 27746846Joseph SS, Joseph AW, Smith JI, Niziol LM, Musch DC, Nelson CC. Evaluation of Patients with Facial Palsy and Ophthalmic Sequelae: A 23-Year Retrospective Review. Ophthalmic Epidemiol. 2017 Oct;24(5):341-345. doi: 10.1080/09286586.2017.1294186. Epub 2017 Mar 20.
PubMed 28319442Faris C, Tessler O, Heiser A, Hadlock T, Jowett N. Evaluation of Societal Health Utility of Facial Palsy and Facial Reanimation. JAMA Facial Plast Surg. 2018 Dec 1;20(6):480-487. doi: 10.1001/jamafacial.2018.0866.
PubMed 30178066D'Souza AF, Rebello SRJIJoT, Rehabilitation. Comparing the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in acute Bell's palsy: a pilot randomised clinical trial. 2021;28(3):1-8.
Park Y-K, Lee CI, Lee JH, Lee H-J, Lee Y-k, Seo J-C, et al. A Facial Chuna Manual Therapy for Peripheral Facial Nerve Palsy. 2019;36(4):197-203
Markey JD, Loyo M. Latest advances in the management of facial synkinesis. Curr Opin Otolaryngol Head Neck Surg. 2017 Aug;25(4):265-272. doi: 10.1097/MOO.0000000000000376.
PubMed 28604403Jo YK, Lee YJ, Jeon JH, Kim YIJJoHM. Review on Clinical Studies of Facial Palsy Sequelae Treatment. 2019;28(1):1-12.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04993417
- Acronym / sponsor ID
- REC/Lhr/20/0209 Aysha
- Conditions
- Facial Palsy
- Keywords
- Facial nerve palsy, Mime therapy, Motor imagery technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Aug 2021 (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.
This project was a Randomized clinical trial conducted to compare the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients so that we can have best treatment option for patients of facial palsy. Duration was of 6 months, convenient sampling was done, subjects following eligibility criteria from Imran Idrees Teaching hospital and Idrees Hospital Sialkot, were randomly allocated in two groups via computer generated method, baseline assessment was done, MIT Group received motor imagery technique, 45 min session (3 times a week for 3 months) plus the EMS (10-15 min), while the MT Group received mime therapy 30-45 min session (3 times a week for 3 months) plus the EMS (10-15 min). Outcome measures were collected for both groups at before treatment (T0) and at the end of the treatment i-e after 3 months (T1). The outcome measures were severity of paresis, facial symmetry and intensity of depression measured by using House-Brackmann Scale, Sunnybrook Facial Grading System and Beck Depression Inventory Scale, respectively. Data was analyzed by using SPSS version 24.0.
Detailed description
Facial palsy is due to the damage in the facial nerve that supplies the muscles of the face. Peripheral facial nerve paralysis can have various causes, such as Bell's palsy, which is the most common cause. Among secondary cause, tumors and the adverse effects of surgery for tumor pathologies such as, acoustic neuroma and facial nerve schwannoma are the most prevalent. The prognosis for FNP is complete recovery in roughly 80% of cases with Bell's palsy, whereas 15% experiences some type of permanent nerve damage, with the remaining 5% enduring severe sequelae. To this end, FNP should be treated in a multidisciplinary setting, in which physical therapy, psychological and medical or surgical interventions are integrated. The current study has compared the effects of motor imagery technique and mime therapy on facial expressions in facial palsy patients. The current study was novel in a way that there is no evidence of superiority of any rehabilitative treatment compared with another in the recovery of FNP, which was clearly determined by the current study.
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 along with EMS | Experimental | Other: Mime Therapy along with EMSMT Group: Mime Therapy along with EMS |
| Motor imagery technique along with EMS | Experimental | Other: Motor imagery technique along with EMSMIT Group: Motor imagery technique along with EMS |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Unilateral facial palsy more than 6 months
- Age 20-60 years
- House-Brackmann Scale Score ≥3
- Both genders
Key exclusion criteria (4 listed)
- Pregnant women
- Psychological treatment for any psychiatric disorder
- Participants with the history of any tumor
- Diabetes
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 technique along with EMSAll the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. The patients were mentioned to play out the emotional facial appearances for non-verbal correspondence i-e pleasure, misery, interest, appall, dread, irritation and shock. Patients were then requestedto envision himself winking, for instance, envisioning himself in a wonderful and natural social setting, at that point the patient cognitively addresses, with his eyes shut, the movement of decaying the recognized central issues, without creating any specific movement. | Other | Motor imagery technique along with EMS |
| Mime Therapy along with EMSAll the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. Mime treatment incorporates self kneading of face and neck, breathing and relaxation works out, activities to synchronize the two sides and diminish synkinesis and for eye and lip closure per the myofascial way to deal with recovery, letter and word practices and expressive activities. | Other | Mime Therapy along with EMS |
Primary outcome
House-Brackmann Scale (HBS)
Time frame: 12th Week
House-Brackmann Facial Grading System comprises of six evaluations, where grade 1 addresses normal function and grade VI addresses complete loss of motion. It is quite possibly the most generally utilized scales and has been appeared to have great between rater reliability anyway its affectability to change in facial symmetry is low.
1 secondary outcome
Sunnybrook Facial Grading System (SFGS)
Time frame: 12 Week
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 6 Aug 2021.
- Background: PubMed 29110887Garro A, Nigrovic LE. Managing Peripheral Facial Palsy. Ann Emerg Med. 2018 May;71(5):618-624. doi: 10.1016/j.annemergmed.2017.08.039. Epub 2017 Oct 27. No abstract available.
- Background: PubMed 30262166Robinson MW, Baiungo J. Facial Rehabilitation: Evaluation and Treatment Strategies for the Patient with Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1151-1167. doi: 10.1016/j.otc.2018.07.011. Epub 2018 Sep 24.
- Background: PubMed 27939040Codari M, Pucciarelli V, Stangoni F, Zago M, Tarabbia F, Biglioli F, Sforza C. Facial thirds-based evaluation of facial asymmetry using stereophotogrammetric devices: Application to facial palsy subjects. J Craniomaxillofac Surg. 2017 Jan;45(1):76-81. doi: 10.1016/j.jcms.2016.11.003. Epub 2016 Nov 17.
- Background: PubMed 30172554Dusseldorp JR, van Veen MM, Mohan S, Hadlock TA. Outcome Tracking in Facial Palsy. Otolaryngol Clin North Am. 2018 Dec;51(6):1033-1050. doi: 10.1016/j.otc.2018.07.003. Epub 2018 Aug 29.
- Background: PubMed 31021433Greene JJ, Guarin DL, Tavares J, Fortier E, Robinson M, Dusseldorp J, Quatela O, Jowett N, Hadlock T. The spectrum of facial palsy: The MEEI facial palsy photo and video standard set. Laryngoscope. 2020 Jan;130(1):32-37. doi: 10.1002/lary.27986. Epub 2019 Apr 25.
- Background: PubMed 27746846Monsanto RD, Bittencourt AG, Bobato Neto NJ, Beilke SC, Lorenzetti FT, Salomone R. Treatment and Prognosis of Facial Palsy on Ramsay Hunt Syndrome: Results Based on a Review of the Literature. Int Arch Otorhinolaryngol. 2016 Oct;20(4):394-400. doi: 10.1055/s-0036-1584267. Epub 2016 May 30.
- Background: PubMed 28319442Joseph SS, Joseph AW, Smith JI, Niziol LM, Musch DC, Nelson CC. Evaluation of Patients with Facial Palsy and Ophthalmic Sequelae: A 23-Year Retrospective Review. Ophthalmic Epidemiol. 2017 Oct;24(5):341-345. doi: 10.1080/09286586.2017.1294186. Epub 2017 Mar 20.
- Background: PubMed 30178066Faris C, Tessler O, Heiser A, Hadlock T, Jowett N. Evaluation of Societal Health Utility of Facial Palsy and Facial Reanimation. JAMA Facial Plast Surg. 2018 Dec 1;20(6):480-487. doi: 10.1001/jamafacial.2018.0866.
- BackgroundD'Souza AF, Rebello SRJIJoT, Rehabilitation. Comparing the effectiveness of mime therapy and neuromuscular re-education in improving facial symmetry and function in acute Bell's palsy: a pilot randomised clinical trial. 2021;28(3):1-8.
- BackgroundPark Y-K, Lee CI, Lee JH, Lee H-J, Lee Y-k, Seo J-C, et al. A Facial Chuna Manual Therapy for Peripheral Facial Nerve Palsy. 2019;36(4):197-203
- Background: PubMed 28604403Markey JD, Loyo M. Latest advances in the management of facial synkinesis. Curr Opin Otolaryngol Head Neck Surg. 2017 Aug;25(4):265-272. doi: 10.1097/MOO.0000000000000376.
- BackgroundJo YK, Lee YJ, Jeon JH, Kim YIJJoHM. Review on Clinical Studies of Facial Palsy Sequelae Treatment. 2019;28(1):1-12.
- 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.
Mehwish Ikram, MS 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 Motor imagery technique along with EMS and Mime Therapy along with EMS in people with Facial 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 4 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 6 Aug 2021. 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?
House-Brackmann Scale (HBS) (time frame: 12th Week). 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 NCT04993417, which also lists 12 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 6 Aug 2021.