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IRCT20241001063232N1 IRCT 2024-10-20 University of Lahore Proprioceptive neuromuscular facilitation in adjunct to mirror therapy on clinical recovery ,synkinesis and quality of life in patients with Bell's palsy Proprioceptive neuromuscular facilitation in adjunct to mirror therapy on clinical recovery ,synkinesis and quality of life in patients with Bell's palsy 2024-02-15 anticipated 60 Complete https://irct.ir/trial/79640 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be used by one of the research team members who will be blinded and not involve in patients recruitment or assessment or data analysis. Participants are randomly allocated into two groups through lottery method, Blinding description: This is single blinded study in which accessor will be unaware of treatment. 2-3 Bell palsy is an idiopathic peripheral nerve disorder involving the facial nerve (ie, cranial nerve VII) and manifesting as acute, ipsilateral facial muscle weakness. It affects individuals across multiple ages and both sexes, with an annual incidence ranging from 11.5 to 53.3 per 100,000 persons across multiple populations.. Intervention 1: Intervention group: The participants randomly allocated in Group A will be received the PNF with mirror therapy (MT). After electrical muscle stimulation proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch as shown in figure 1 using mirror. Participants will be sit upright, maintaining good posture. Keep mirror at eye level. With both eyes open, look into mirror with only on unaffected side. Patients will be observed the mirror reflection for one to two minutes, then trying to visualize the mirror image as the affected side. Once the subject will be engaged with mirror side then proprioceptive exercises will be performed. Intervention 2: Intervention group: In group B patients will be received PNF without mirror therapy (MT). After electrical muscle stimulation, proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining the confidentially When: Data will be available after the publication of findings till six months To whom: Sadia Ghafoor Conditions: For research purpose Where to obtain: To the corresponding author of the study , Sadia Ghafoor and can contact on +92 304 787995 , sgrana1@outlook.com How to obtain: Open access and there is the traditional public data release where anyone can get access to the data Comments:
public Sadia Ghafoor
1-kn Defence Road near Bhuptian Chowk Lahore
Lahore Pakistan 55150 +92 304 787995 sgrana14@outlook.com University of Lahore scientific Sadia Ghafoor
1 km Defence road near Bhuptian Chowk Lahore
Lahore Pakistan 55150 +92 304 787995 sgrana14@outlook.com University of Lahore Pakistan Aged between 25-50 years Both Male and females Patients with unilateral Bells’ Palsy diagnosed by neurologist Patients with moderate to severe Bell’s palsy (House-Brackmann Scale facial nerve grading 3 and 4) Patients with unilateral bell’s palsy 20 years 50 years Both Patients with Autoimmune/ hematologic disease Patients with Inflammatory disease(e.g. Rheumatoid arthritis) Patients with any neurodegenerative disease Patients with cognitive impairments G51.0 Bell's palsy Treatment - Other Treatment - Other Intervention group: The participants randomly allocated in Group A will be received the PNF with mirror therapy (MT). After electrical muscle stimulation proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch as shown in figure 1 using mirror. Participants will be sit upright, maintaining good posture. Keep mirror at eye level. With both eyes open, look into mirror with only on unaffected side. Patients will be observed the mirror reflection for one to two minutes, then trying to visualize the mirror image as the affected side. Once the subject will be engaged with mirror side then proprioceptive exercises will be performed. Intervention group: In group B patients will be received PNF without mirror therapy (MT). After electrical muscle stimulation, proprioceptive neuromuscular facilitation techniques (PNF) will be done. Proprioceptive neuromuscular facilitation techniques (PNF) that will be used are rhythmic initiation and repeated stretch. The House-Brackmann Scale (HBS) is one of several analysis tools that have been developed to quantify facial function and provide reproducible information in measuring the global degree of paresis and paralysis. Timepoint: 9th weeks. Method of measurement: It is a widely accepted system and is simple, sensitive, accurate, and reliable, grading facial function in 6 stages, from normal (HB I) to total paralysis (HB VI). The Synkinesis Assessment Questionnaire comprises nine questions and is a valid and reliable measurement for synkinesis. It correlates well with the synkinesis aspect of FGS. Timepoint: 9th week. Method of measurement: Chuang et al. introduced a four-category classification: I) Good smile with mild synkinesis, II) Acceptable smile with moderate to severe synkinesis, III) Unacceptable smile with severe synkinesis, and IV) Poor smile with mild synkinesis. The Facial Clinimetric Evaluation Scale (FaCE) is a patient-based instrument that measures facial impairment and disability in evaluating quality-of-life issues that are caused by facial disability. Timepoint: 9th weeks. Method of measurement: This questionnaire consists of 15 questions on a 5-point Likert Scale and comprises 6 domains: facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. Total and domain scores range from 0 (worst) to 100 (best). This scale has been used in several studies on patient satisfaction following treatment. University of Lahore Approved 2024-03-07 Research Ethics Committee of University of Lahore University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan