Bell PalsyNCT05855928
Effectiveness of ES and MT VS ES and PNF Technique Among Bells Palsy Patients
A study testing Mime Therapy and PNF Technique in people with Bell Palsy, run by Superior University at 1 site in Pakistan.
Trial summary
To determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength \& restoring lost motor function in the patients of Bell's palsy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Mime Therapy and PNF Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 31 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Acute, unilateral, lower motor neuron bells palsy patient with house-backmann scale 4
- Acute onset 1-3 weeks
- Age group 20-40 years
- Who were are willing to be a part of the study
- Patients with the Bell's palsy (Facial paralysis , idiopathic facial paralysis and the herpetic facial paralysis)
Who cannot join
- • Patient who had the autoimmune disorder, tumors, recent head injury
- The subject long with the surgery for ear and the fascial nerve palsy
- Metal dental implants, and pregnant women
- The patient with any peripheral vascular diseases
- Central fascial palsy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Superior University CRC
Lahore, Punjab Province
About this study
Official title: Effectiveness of Electrical Stimulation and Mime Therapy Versus Electrical Stimulation and PNF Technique Among Bells Palsy Patients
To determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength \& restoring lost motor function in the patients of Bell's palsy
- Conditions
- Bell Palsy
- Being tested
- Mime Therapy, PNF Technique
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mime TherapyDiagnostic test
electrical stimulation with the MIME therapy and protocol
PNF TechniqueDiagnostic test
electrical stimulation with the PNF technique with the routine physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation and Mime Therapy | Other | Not described Receives: Diagnostic Test: Mime Therapy |
| Electrical Stimulation and PNF Technique | Experimental | Not described Receives: Diagnostic Test: PNF Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial disability index(FDI) Scale
Physical function, Difficulties
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion31 Aug 2023 (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.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855928
- Sponsor's protocol ID
- DPT/Batch-Fall18/526
- Status last verified
- May 2023
- First submitted
- 18 Mar 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Electrical Stimulation and Mime Therapy Versus Electrical Stimulation and PNF Technique Among Bells Palsy Patients
- ClinicalTrials.gov ID
- NCT05855928
- Acronym / sponsor ID
- DPT/Batch-Fall18/526
- Conditions
- Bell Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 May 2023 (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 determine the effectiveness of electrical stimulation with MIME therapy versus electrical stimulation with PNF technique for improving strength \& restoring lost motor function in the patients of Bell's palsy
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation and Mime Therapy | Other | Diagnostic Test: Mime Therapy |
| Electrical Stimulation and PNF Technique | Experimental | Diagnostic Test: PNF Technique |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Acute, unilateral, lower motor neuron bells palsy patient with house-backmann scale 4
Key exclusion criteria (5 listed)
- • Patient who had the autoimmune disorder, tumors, recent head injury
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 |
|---|---|---|
| Mime Therapyelectrical stimulation with the MIME therapy and protocol | Diagnostic test | Electrical Stimulation and Mime Therapy |
| PNF Techniqueelectrical stimulation with the PNF technique with the routine physical therapy | Diagnostic test | Electrical Stimulation and PNF Technique |
Primary outcome
Facial disability index(FDI) Scale
Time frame: 6 Months
Physical function, Difficulties
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mime Therapy and PNF Technique in people with Bell Palsy, run by Superior 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 5 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: status not confirmed, as of the sponsor's last update on 12 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javeria khalid, DPT (+923074464878, javeriakhalid14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial disability index(FDI) Scale (time frame: 6 Months). 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 12 May 2023.