Comparison of Motor Imagery Technique and Mime Therapy on Facial Expressions in Facial Palsy Patients

August 5, 2021 updated by: Riphah International University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan
        • Imran Idrees Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral facial palsy more than 6 months
  • Age 20-60 years
  • House-Brackmann Scale Score ≥3
  • Both genders

Exclusion Criteria:

  • Pregnant women
  • Psychological treatment for any psychiatric disorder
  • Participants with the history of any tumor
  • Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mime Therapy along with EMS
MT Group: Mime Therapy along with EMS
Other: Mime Therapy along with EMS
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.
Experimental: Motor imagery technique along with EMS
MIT Group: Motor imagery technique along with EMS
Other: Motor imagery technique along with EMS
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12th Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sunnybrook Facial Grading System (SFGS)
Time Frame: 12 Week
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
12 Week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory Scale (BDI)
Time Frame: 12 Week
The 21-item Beck Depression Inventory comprises of four proclamations that depict expanding powers of depressive symptoms and incorporates substantial and intellectual emotional manifestations, everything is isolated into a scale from 0 to 3, mirroring the patient's feelings in the past fourteen days. An absolute score of each of the 21 things are created; score of 14 or above is demonstrative of depressive indications. Depressive manifestations were sorted as, minimal-moderate (14-19), moderate-severe (20-29) and severe (30-63)
12 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/Lhr/20/0209 Aysha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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