Bell PalsyNCT07028138
Effectiveness of Electrical Stimulation With Mime Therapy Versus Electrical Stimulation With Proprioceptive Neuromuscular Facilitation on Improving Facial Asymmetry and Quality of Life in Patients With Bell's Palsy
A study testing electrical stimulation with mime therapy in people with Bell Palsy, run by Shalamar Institute of Health Sciences.
Trial summary
To compare the effect of electrical stimulation with mime therapy versus electrical stimulation with proprioceptive neuromuscular facilitation on improving facial asymmetry and quality of life in patients with Bell's palsy. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- electrical stimulation with mime therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2025to 29 Dec 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Idiopathic Bell's Palsy Subacute and acute Bell's Palsy
Who cannot join
- UMNL facial palsy patient Non-compliant patient Patient with any psychiatric issues Patients with Dental implants Patients with any Skin condition Patients with Stroke related Bell's Palsy
About this study
To compare the effect of electrical stimulation with mime therapy versus electrical stimulation with proprioceptive neuromuscular facilitation on improving facial asymmetry and quality of life in patients with Bell's palsy.
Read the detailed description
- Introduction: (Background, Preliminary Literature Review and Significance of the Study): One paragraph related to global work on the subject, one paragraph related to local (Pakistan) work and one paragraph related to institutional work with a total of 5 to 8 references. Last paragraph should indicate the importance of work and what information/gaps are missing on topic/subject and how this study will contribute to knowledge .
Bell palsy is a sudden paralysis or weakness of the facial muscles that becomes worse over 48 hours. Bell palsy is caused by damage to the facial nerve (the 7th cranial nerve) (1). Facial nerve, which regulates facial expression muscles and transmits taste sensation from the anterior two-thirds of the tongue, becomes swollen and compressed-usually secondary to reactivation of latent herpes simplex virus type 1 (HSV-1)-in the tight bony facial canal. Thus, individuals can suddenly develop drooping of one side of the face, difficulty in blinking, hyperacusis, difficulty in moving the mouth, facial motion and expression, which makes it more difficult to communicate and tends to lower an individual's quality of life (2). Mime therapy is an advanced rehabilitation method that integrates the techniques of mime with special facial exercises to improve facial symmetry, muscle control, and emotional expression of patients with facial nerve palsy. The therapy aims to isolate facial movements, decrease synkinesis (spontaneous muscle activity), and retrain natural expressions (3). Proprioceptive neuromuscular facilitation (PNF) therapy utilizes coordinated patterns of movement to strengthen muscles and enhance neuromuscular coordination. This technique restores muscle function by activating the interaction between nerves and muscles with guided exercises (4). Electrical Stimulation (ES) applies electrical currents to activate muscles or nerves for therapeutic objectives. It helps enhance muscle strength, decrease pain, and enhance healing by causing muscle contractions or stimulation of nerves using electrodes applied on the skin. It is mostly used in the treatment of Bell's palsy(5).
Worldwide, Bell's palsy affects around 11 to 40 people per 100,000 each year with a lifetime risk of 1 in 60. It is seen most commonly in adults between 15 and 60 years of age with a mild predilection for involvement on the right side. The incidence in the United States is 24.5 per 100,000 each year. In countries like Egypt, the rate increases to 107 per 100,000 (6). In Pakistan, it differs geographically. In a study conducted in Lahore, 68.3% of the cases of facial paralysis were due to Bell's palsy and had a higher incidence in females and a right-sided predominance. In colder climates, it was most common among the 11-20 and 31-40 years of age and occurred with a peak during winter months (7) (8). European research demonstrates that PNF in combination with electrical stimulation enhances facial muscle coordination and accelerates recovery (9). In Asia, mime therapy combined with electrical stimulation has been noted to increase the strength of muscles and neuromuscular control (10). Clinical trials and reviews published most recently reveal that the use of electrical stimulation combined with either mime therapy or PNF provides more advantageous results than the use of electrical stimulation alone. Direct comparisons between the combined therapies are still limited, however, and imply that more research is warranted. There is limited direct comparison of combination therapies, leaving clinicians without evidence-based guidance and often having to make decisions based on personal choice or access to resources. This may result in suboptimal results.
Bell's palsy causes facial paralysis and loss of movement and expression. While electrical stimulation (ES), mime therapy, and proprioceptive neuromuscular facilitation (PNF) are commonly employed treatments, little is known about the combinations' effectiveness. The purpose of this study is to establish whether adding ES with mime therapy or with PNF yields better outcomes in rehabilitation.
- Conditions
- Bell Palsy
- Being tested
- electrical stimulation with mime therapy
- Keywords
- PNF, ES
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulation with mime therapyOther
Also called electrical stimulation with proprioceptive neuromuscular facilitation
A total of 38 Bell's palsy patients will be randomly selected and divided into two equal groups at Shalamar Hospital.
Group A will receive mime therapy with electrical stimulation, including facial massage, relaxation, stretching, and facial movement exercises.
Group B will undergo electrical stimulation followed by proprioceptive neuromuscular facilitation (PNF) with resisted facial and tongue exercises.
Each group will receive 30-minute sessions, three times per week, for six weeks.
Outcomes will be assessed using the Facial Disability Index (FDI), Sunnybrook Facial Grading System, and SF-12 quality of life scale.
Evaluations will be conducted at baseline, after one month, and at a 2-3 month follow-up.
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation with mime therapy | Other | Mime therapy will begin with manual facial massage techniques such as tapping, stroking, and hacking, aimed at improving blood circulation and stimulating muscle activity. This will be followed by breathing and relaxation exercises to reduce muscular tension. Stretching exercises will then be performed on the affected side, including sustained pressure on trigger points in the forehead, eyes, nostrils, lips, and neck for approximately two minutes. Facial movement exercises such as eyebrow raising, eye closure, frowning, snarling, smiling, and pouting will be practiced, with each movement repeated 15 times and held for 5 to 10 seconds to encourage neuromuscular re-education. Each session will last 30 minutes and will be conducted three times per week over a six-week period. Receives: Other: electrical stimulation with mime therapy |
| electrical stimulation with proprioceptive neuromuscular facilitation (PNF) | Other | Group B will undergo electrical stimulation followed by proprioceptive neuromuscular facilitation (PNF). The same stimulation parameters as Group A will be used. PNF techniques will include a series of resisted facial movements such as closed-mouth smiling, lip pursing, mouth angle elevation, lower lip depression, chin tightening, and wide mouth opening, each performed with resistance and held for five seconds. These will be followed by tongue exercises including forward protrusion, elevation toward the nose, and lateral movement to both sides, with each held for five seconds. Each session will last 30 minutes and follow the same frequency and duration as Group A. Receives: Other: electrical stimulation with mime therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
improving facial asymmetry
Outcome measures will include the Facial Disability Index (FDI), assessing both physical and social function, and the Sunnybrook Facial Grading System, used to evaluate facial symmetry, voluntary movement, and synkinesis before and during treatment
Measured: 6 weeks
Secondary outcomes (1)
improved Quality of life (SF-12 scores)
The SF-12 is one of the most widely used instruments for assessing self-reported health-related quality of life , A score of <40 in either PCS or MCS is used as a cut-off to indicate impaired or poor quality of life.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start28 Aug 2025 (estimated)
- Primary completion29 Nov 2025 (estimated)
- Study completion29 Dec 2025 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- electrical stimulation with mime therapy versus electrical stimulation with proprioceptive neuromuscular facilitation on improving facial asymmetry and quality of life in patients with Bell's palsy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028138
- Sponsor's protocol ID
- ShalamarIHSSSAHS
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Stimulation With Mime Therapy Versus Electrical Stimulation With Proprioceptive Neuromuscular Facilitation on Improving Facial Asymmetry and Quality of Life in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT07028138
- Acronym / sponsor ID
- ShalamarIHSSSAHS
- Conditions
- Bell Palsy
- Keywords
- PNF, ES
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shalamar Institute of Health SciencesUniversity, hospital or other
- Study start
- 28 Aug 2025 (estimated)
- Primary completion
- 29 Nov 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 19 Jun 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.
To compare the effect of electrical stimulation with mime therapy versus electrical stimulation with proprioceptive neuromuscular facilitation on improving facial asymmetry and quality of life in patients with Bell's palsy.
Detailed description
- Introduction: (Background, Preliminary Literature Review and Significance of the Study): One paragraph related to global work on the subject, one paragraph related to local (Pakistan) work and one paragraph related to institutional work with a total of 5 to 8 references. Last paragraph should indicate the importance of work and what information/gaps are missing on topic/subject and how this study will contribute to knowledge .
Bell palsy is a sudden paralysis or weakness of the facial muscles that becomes worse over 48 hours. Bell palsy is caused by damage to the facial nerve (the 7th cranial nerve) (1). Facial nerve, which regulates facial expression muscles and transmits taste sensation from the anterior two-thirds of the tongue, becomes swollen and compressed-usually secondary to reactivation of latent herpes simplex virus type 1 (HSV-1)-in the tight bony facial canal. Thus, individuals can suddenly develop drooping of one side of the face, difficulty in blinking, hyperacusis, difficulty in moving the mouth, facial motion and expression, which makes it more difficult to communicate and tends to lower an individual's quality of life (2). Mime therapy is an advanced rehabilitation method that integrates the techniques of mime with special facial exercises to improve facial symmetry, muscle control, and emotional expression of patients with facial nerve palsy. The therapy aims to isolate facial movements, decrease synkinesis (spontaneous muscle activity), and retrain natural expressions (3). Proprioceptive neuromuscular facilitation (PNF) therapy utilizes coordinated patterns of movement to strengthen muscles and enhance neuromuscular coordination. This technique restores muscle function by activating the interaction between nerves and muscles with guided exercises (4). Electrical Stimulation (ES) applies electrical currents to activate muscles or nerves for therapeutic objectives. It helps enhance muscle strength, decrease pain, and enhance healing by causing muscle contractions or stimulation of nerves using electrodes applied on the skin. It is mostly used in the treatment of Bell's palsy(5).
Worldwide, Bell's palsy affects around 11 to 40 people per 100,000 each year with a lifetime risk of 1 in 60. It is seen most commonly in adults between 15 and 60 years of age with a mild predilection for involvement on the right side. The incidence in the United States is 24.5 per 100,000 each year. In countries like Egypt, the rate increases to 107 per 100,000 (6). In Pakistan, it differs geographically. In a study conducted in Lahore, 68.3% of the cases of facial paralysis were due to Bell's palsy and had a higher incidence in females and a right-sided predominance. In colder climates, it was most common among the 11-20 and 31-40 years of age and occurred with a peak during winter months (7) (8). European research demonstrates that PNF in combination with electrical stimulation enhances facial muscle coordination and accelerates recovery (9). In Asia, mime therapy combined with electrical stimulation has been noted to increase the strength of muscles and neuromuscular control (10). Clinical trials and reviews published most recently reveal that the use of electrical stimulation combined with either mime therapy or PNF provides more advantageous results than the use of electrical stimulation alone. Direct comparisons between the combined therapies are still limited, however, and imply that more research is warranted. There is limited direct comparison of combination therapies, leaving clinicians without evidence-based guidance and often having to make decisions based on personal choice or access to resources. This may result in suboptimal results.
Bell's palsy causes facial paralysis and loss of movement and expression. While electrical stimulation (ES), mime therapy, and proprioceptive neuromuscular facilitation (PNF) are commonly employed treatments, little is known about the combinations' effectiveness. The purpose of this study is to establish whether adding ES with mime therapy or with PNF yields better outcomes in rehabilitation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- electrical stimulation with mime therapy versus electrical stimulation with proprioceptive neuromuscular facilitation on improving facial asymmetry and quality of life in patients with Bell's palsy
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation with mime therapy | Other | Other: electrical stimulation with mime therapyMime therapy will begin with manual facial massage techniques such as tapping, stroking, and hacking, aimed at improving blood circulation and stimulating muscle activity. This will be followed by breathing and relaxation exercises to reduce muscular tension. Stretching exercises will then be performed on the affected side, including sustained pressure on trigger points in the forehead, eyes, nostrils, lips, and neck for approximately two minutes. Facial movement exercises such as eyebrow raising, eye closure, frowning, snarling, smiling, and pouting will be practiced, with each movement repeated 15 times and held for 5 to 10 seconds to encourage neuromuscular re-education. Each session will last 30 minutes and will be conducted three times per week over a six-week period. |
| electrical stimulation with proprioceptive neuromuscular facilitation (PNF) | Other | Other: electrical stimulation with mime therapyGroup B will undergo electrical stimulation followed by proprioceptive neuromuscular facilitation (PNF). The same stimulation parameters as Group A will be used. PNF techniques will include a series of resisted facial movements such as closed-mouth smiling, lip pursing, mouth angle elevation, lower lip depression, chin tightening, and wide mouth opening, each performed with resistance and held for five seconds. These will be followed by tongue exercises including forward protrusion, elevation toward the nose, and lateral movement to both sides, with each held for five seconds. Each session will last 30 minutes and follow the same frequency and duration as Group A. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Idiopathic Bell's Palsy Subacute and acute Bell's Palsy
Key exclusion criteria (1 listed)
- UMNL facial palsy patient Non-compliant patient Patient with any psychiatric issues Patients with Dental implants Patients with any Skin condition Patients with Stroke related Bell's Palsy
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 |
|---|---|---|
| electrical stimulation with mime therapyAlso: electrical stimulation with proprioceptive neuromuscular facilitationA total of 38 Bell's palsy patients will be randomly selected and divided into two equal groups at Shalamar Hospital. Group A will receive mime therapy with electrical stimulation, including facial massage, relaxation, stretching, and facial movement exercises. Group B will undergo electrical stimulation followed by proprioceptive neuromuscular facilitation (PNF) with resisted facial and tongue exercises. Each group will receive 30-minute sessions, three times per week, for six weeks. Outcomes will be assessed using the Facial Disability Index (FDI), Sunnybrook Facial Grading System, and SF-12 quality of life scale. Evaluations will be conducted at baseline, after one month, and at a 2-3 month follow-up. | Other | electrical stimulation with mime therapy, electrical stimulation with proprioceptive neuromuscular facilitation (PNF) |
Primary outcome
improving facial asymmetry
Time frame: 6 weeks
Outcome measures will include the Facial Disability Index (FDI), assessing both physical and social function, and the Sunnybrook Facial Grading System, used to evaluate facial symmetry, voluntary movement, and synkinesis before and during treatment
1 secondary outcome
improved Quality of life (SF-12 scores)
Time frame: 6 weeks
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 19 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation with mime therapy in people with Bell Palsy, run by Shalamar Institute of Health Sciences.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
improving facial asymmetry (time frame: 6 weeks). 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 19 Jun 2025.