Bell's PalsyNCT07078617
Effectiveness of PNF and STM in Bell Palsy
A study testing Proprioceptive Neuromuscular Facilitation and Soft Tissue Mobilization along with exercise in people with Bell's Palsy, run by Elite College of Management Sciences, Gujranwala, Pakistan at 1 site in Pakistan.
Trial summary
Our study aims to determine the efficacy of PNF and Soft tissue mobilization techniques with exercise for Bell's palsy. It ascertains which intervention yields better outcomes and has greater effect on recovery. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Bell's Palsy
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Soft Tissue Mobilization along with exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 1 Jul 2025
- 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 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 25-50 years
- sudden onset of one-sided Bell's palsy
- Ability and Eagerness to provide informed consent in written form
Who cannot join
- Uncontrolled Hypertension
- Uncooperative patients and those who don't follow instructions.
- Previous mental disorder that may affect participation.
- Preexisting ear surgery
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al Raee Hospital Gujranwala, Salamat Hospital Gujranwala, Chaudhary Hospital Gujranwala
Gujranwala, Punjab Province, 52200
About this study
Official title: Comparison of PNF and Soft Tissue Mobilization Techniques Along With Exercise for the Treatment of Bell's Palsy
Our study aims to determine the efficacy of PNF and Soft tissue mobilization techniques with exercise for Bell's palsy. It ascertains which intervention yields better outcomes and has greater effect on recovery.
Read the detailed description
It is a randomized controlled trial. This study includes 28 participants allocated into two groups by coin tossing method. Group A receives PNF and Group B receives soft tissue mobilization along with exercise. Both of the groups receive electrical stimulation as baseline treatment. The assessment of participants is done by using facial disability index and House Brackmann scale.
- Conditions
- Bell's Palsy
- Being tested
- Proprioceptive Neuromuscular Facilitation, Soft Tissue Mobilization along with exercise
- Keywords
- Facial disability index, PNF, House Brackmann scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationOther
PNF technique given for 3-4 days/week and electrical stimulation of DL-2 stimulator with 90 repetitions on each motor point of facial muscle for 3-4 days/week.
Soft Tissue Mobilization along with exerciseOther
Soft tissue mobilization along with facial exercise 3- days/ week and electrical stimulation of DL-2 stimulator with 90 repetitions on each motor point of facial muscle for 3-4 days/week.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation | Experimental | Repeated stretch and Hold relax method used in this technique. Receives: Other: Proprioceptive Neuromuscular Facilitation |
| Soft Tissue Mobilization along with exercise | Experimental | Effleurage, Kneading and hacking along with facial exercises Receives: Other: Soft Tissue Mobilization along with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial disability index
in 1996, this scale was invented. This tool is used to evaluate functional and psychological effects of cranial nerve VII dysfunction like Bell's palsy. It consists of two subscales one is Physical Function and second is Social/Wellbeing Function, each with a range 0 to 100 where higher score shows better function and lesser disability.
Measured: 4 weeks
Secondary outcomes (1)
House Brackmann scale
This scale was invented in 1985 by DE Brackmann and Dr.John W.House. This scale is used to evaluate the severity of cranial nerve VII. it consists of six grades. Grade 1 indicates Normal and Grade 6 indicates complete paralysis.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Apr 2025
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Bell's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elite College of Management Sciences, Gujranwala, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Rafiq, PhD, Principal investigator, Elite College of Management sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078617
- Sponsor's protocol ID
- 2020-GCUF-079348
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amjad A, Jamil A, Fatima N, Javaid HB, Zahid H. Effects of Kabat rehabilitation versus mime therapy on facial disability and synkinesis in patients of Bell's palsy. J Pak Med Assoc. 2024 Nov;74(11):1927-1931. doi: 10.47391/JPMA.11247.
PubMed 39548608Burelo-Peregrino EG, Salas-Magana M, Arias-Vazquez PI, Tovilla-Zarate CA, Bermudez-Ocana DY, Lopez-Narvaez ML, Guzman-Priego CG, Gonzalez-Castro TB, Juarez-Rojop IE. Efficacy of electrotherapy in Bell's palsy treatment: A systematic review. J Back Musculoskelet Rehabil. 2020;33(5):865-874. doi: 10.3233/BMR-171031.
PubMed 32144972Khan AJ, Szczepura A, Palmer S, Bark C, Neville C, Thomson D, Martin H, Nduka C. Physical therapy for facial nerve paralysis (Bell's palsy): An updated and extended systematic review of the evidence for facial exercise therapy. Clin Rehabil. 2022 Nov;36(11):1424-1449. doi: 10.1177/02692155221110727. Epub 2022 Jul 5.
PubMed 35787015Albishi AM, Altowairqi RT, Alhadlaq SA, Alsulboud SK, Alhusaini AA, Alokaily AO, Alotibi M. Cross-cultural adaptation, reliability, and validation of the Arabic version of the Motor Activity Log (MAL-30) Scale in patients with stroke in Saudi Arabia. Disabil Rehabil. 2025 Dec;47(26):7042-7050. doi: 10.1080/09638288.2025.2526701. Epub 2025 Jul 3.
PubMed 40607587Eviston TJ, Croxson GR, Kennedy PG, Hadlock T, Krishnan AV. Bell's palsy: aetiology, clinical features and multidisciplinary care. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1356-61. doi: 10.1136/jnnp-2014-309563. Epub 2015 Apr 9.
PubMed 25857657
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of PNF and Soft Tissue Mobilization Techniques Along With Exercise for the Treatment of Bell's Palsy
- ClinicalTrials.gov ID
- NCT07078617
- Acronym / sponsor ID
- 2020-GCUF-079348
- Conditions
- Bell's Palsy
- Keywords
- Facial disability index, PNF, House Brackmann scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Elite College of Management Sciences, Gujranwala, PakistanUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Jul 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.
Our study aims to determine the efficacy of PNF and Soft tissue mobilization techniques with exercise for Bell's palsy. It ascertains which intervention yields better outcomes and has greater effect on recovery.
Detailed description
It is a randomized controlled trial. This study includes 28 participants allocated into two groups by coin tossing method. Group A receives PNF and Group B receives soft tissue mobilization along with exercise. Both of the groups receive electrical stimulation as baseline treatment. The assessment of participants is done by using facial disability index and House Brackmann scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Neuromuscular Facilitation | Experimental | Other: Proprioceptive Neuromuscular FacilitationRepeated stretch and Hold relax method used in this technique. |
| Soft Tissue Mobilization along with exercise | Experimental | Other: Soft Tissue Mobilization along with exerciseEffleurage, Kneading and hacking along with facial exercises |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 25-50 years
- sudden onset of one-sided Bell's palsy
- Ability and Eagerness to provide informed consent in written form
Key exclusion criteria (4 listed)
- Uncontrolled Hypertension
- Uncooperative patients and those who don't follow instructions.
- Previous mental disorder that may affect participation.
- Preexisting ear surgery
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 |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationPNF technique given for 3-4 days/week and electrical stimulation of DL-2 stimulator with 90 repetitions on each motor point of facial muscle for 3-4 days/week. | Other | Proprioceptive Neuromuscular Facilitation |
| Soft Tissue Mobilization along with exerciseSoft tissue mobilization along with facial exercise 3- days/ week and electrical stimulation of DL-2 stimulator with 90 repetitions on each motor point of facial muscle for 3-4 days/week. | Other | Soft Tissue Mobilization along with exercise |
Primary outcome
Facial disability index
Time frame: 4 weeks
in 1996, this scale was invented. This tool is used to evaluate functional and psychological effects of cranial nerve VII dysfunction like Bell's palsy. It consists of two subscales one is Physical Function and second is Social/Wellbeing Function, each with a range 0 to 100 where higher score shows better function and lesser disability.
1 secondary outcome
House Brackmann scale
Time frame: 4 weeks
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 22 Jul 2025.
- Results publication: PubMed 39548608Amjad A, Jamil A, Fatima N, Javaid HB, Zahid H. Effects of Kabat rehabilitation versus mime therapy on facial disability and synkinesis in patients of Bell's palsy. J Pak Med Assoc. 2024 Nov;74(11):1927-1931. doi: 10.47391/JPMA.11247.
- Results publication: PubMed 32144972Burelo-Peregrino EG, Salas-Magana M, Arias-Vazquez PI, Tovilla-Zarate CA, Bermudez-Ocana DY, Lopez-Narvaez ML, Guzman-Priego CG, Gonzalez-Castro TB, Juarez-Rojop IE. Efficacy of electrotherapy in Bell's palsy treatment: A systematic review. J Back Musculoskelet Rehabil. 2020;33(5):865-874. doi: 10.3233/BMR-171031.
- Results publication: PubMed 35787015Khan AJ, Szczepura A, Palmer S, Bark C, Neville C, Thomson D, Martin H, Nduka C. Physical therapy for facial nerve paralysis (Bell's palsy): An updated and extended systematic review of the evidence for facial exercise therapy. Clin Rehabil. 2022 Nov;36(11):1424-1449. doi: 10.1177/02692155221110727. Epub 2022 Jul 5.
- Results publication: PubMed 40607587Albishi AM, Altowairqi RT, Alhadlaq SA, Alsulboud SK, Alhusaini AA, Alokaily AO, Alotibi M. Cross-cultural adaptation, reliability, and validation of the Arabic version of the Motor Activity Log (MAL-30) Scale in patients with stroke in Saudi Arabia. Disabil Rehabil. 2025 Dec;47(26):7042-7050. doi: 10.1080/09638288.2025.2526701. Epub 2025 Jul 3.
- Results publication: PubMed 25857657Eviston TJ, Croxson GR, Kennedy PG, Hadlock T, Krishnan AV. Bell's palsy: aetiology, clinical features and multidisciplinary care. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1356-61. doi: 10.1136/jnnp-2014-309563. Epub 2015 Apr 9.
- Individual participant dataSharing planned: No
Related trials for Bell's Palsy
Enrolling by invitation
EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
Bell Palsy, Bell's Palsy
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.
Imran Rafiq, PhD principal investigator
Elite College of Management sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Soft Tissue Mobilization along with exercise in people with Bell's Palsy, run by Elite College of Management Sciences, Gujranwala, Pakistan 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 3 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 22 Jul 2025. 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?
Facial disability index (time frame: 4 weeks). 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 NCT07078617, which also lists 5 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 22 Jul 2025.