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Enrolling by invitationNCT06775717Updated Jan 15, 2025

Motor Imagery and Mirror Therapy on Synkinesis, Facial Asymmetry, Facial Function and QoF in Bell's Palsy Patients.

An interventional study of Motor Imagery with conventional Treatment and Mirror therapy with conventional Treatment. in Bell Palsy, sponsored by Riphah International University. Enrolling by invitation at 2 sites in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as enrolling by invitation.
  • Registered 3 months after the study started (first participant enrolled Oct 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Bell Palsy

Keywords

  • Facial asymmetry
  • Quality of life
  • Facial function
  • Mirror therapy
  • Motor Imagery
03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's planned enrollment of 42 is close to the median of 42 across 70 interventional studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,193 studies on the registry; 650 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 , 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (estimated)

Study arms

  • Experimental
    Motor Imagery 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.

    Other: Motor Imagery with conventional Treatment · Other: Mirror therapy with conventional Treatment.

  • Active comparator
    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.

    Other: Motor Imagery with conventional Treatment · Other: Mirror therapy with conventional Treatment.

Interventions

  • OtherMotor Imagery with conventional Treatment

    This treatment will be given 5 sessions a week in 4 consecutive weeks.

  • OtherMirror therapy with conventional Treatment.

    This treatment will be given 5 sessions a week in 4 consecutive weeks.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 weeks

  2. 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.

    Time frame: 4 weeks

  3. 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.

    Time frame: 4 weeks

07

Study locations

2 sites
08

References and documents

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 38928530 ↗
  • Patel 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 27997734 ↗
  • Khanzada 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 24189771 ↗
  • Singh 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Feb 2025, 4 months after the start.

Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's planned 4 months is below that.

Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2025
First posted
Jan 15, 2025
StartActual
Oct 1, 2024
Primary completionEst.
Feb 1, 2025
CompletionEst.
May 1, 2025
Last update
Jan 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06775717
Responsible party
Sponsor
First posted
Jan 15, 2025
Start date
Oct 1, 2024
Primary completion
Feb 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jan 15, 2025

Study contacts

Sabiha Arshad
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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