Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201811856336735 Date of Approval: 09/11/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Biofeedback Electromyography Training versus Botulinum Toxin A on Synkinesis and Facial Asymmetry in Bell's Palsy
Official scientific title Biofeedback Electromyography Training versus Botulinum Toxin A on Synkinesis and Facial Asymmetry in Bell's Palsy
Brief summary describing the background and objectives of the trial Facial Nerve Palsy (FNP) is a common medical condition. Bell’s palsy is the most common cause of lower motor facial palsy. In BP, spontaneous complete recovery was found in about 69% of patients. There for about 31% of BP patients who did not receive the appropriate treatment may suffer from incomplete recovery with residual facial muscle weakness with or without one or more of the commonly encountered complications e.g. synkinesis. Synkinesis refers to the abnormal involuntary facial movement that occurs with voluntary movement of a different facial muscle group. Patients experience hypertonic contractures and synkinetic movements such as eye closure with volitional movement of the mouth or midfacial movement during volitional or reflexive eye closure.Surface EMG (electromyography) biofeedback is sometimes used during facial retraining exercises for visual and auditory feedback of facial muscle contractions and it is found effective for improving facial movement symmetry and movement percentages.The use of BTX-A for the management of synkinesis had been studied. And there is significant relief of synkinesis achieved by injecting BTX-A to block the presynaptic release of acetylcholine, causing partial functional paralysis in motor end plate. Purpose of the study: to investigate Biofeedback electromyography retraining versus botulinum toxin A on Synkinesis and facial asymmetry in Bell’s palsy. A pilot study will be conducted to detect sample size. The patient of both gender with synkinesis and facial asymmetry secondary to facial nerve palsy will participate in the study with age ranging from 30-60 years old. the patients will be assigned randomly into three equal groups A, B and C. Synkinesis and facial asymmetry will be assessed by The Sunnybrook Facial Grading System and The House-Brackmann scale.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/11/2018
Actual trial start date
Anticipated date of last follow up 30/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group biofeedback electromyography 24 sessions, three sessions per week two months EMG biofeedback will be used to control these symptoms (using2 channels, one for voluntary movement and the other for involuntary movement). The patient will be asked to try to control synkinesis 15
Experimental Group Botulinum toxin A injection 1-2 units 1-7 days One vial of BTX-A including 500 units is diluted with normal saline (2.5ml) and injected into the muscles (3–7 points) using a tuberculin syringe with a 30- gauge needle. Injection sites are orbicularis oculi, orbicularis oris, zygomatic major, levatorlabiisuperioris and depressor labiiinferioris 15
Control Group traditional physical therapy program for Synkinesis and facial asymmetry 24 sessions.three sessions per week two months physical therapy program includes massage for both sides of face, stretching exercise, neuromuscular re-education exercises. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All patients have Bell's palsy for at least 4-6 months together with a form of synkinesis (ocular or oral). • All patients have long-term rehabilitation poor prognosisand gradual improvement. • All patients will have moderate degree of facial synkinesis and asymmetry according to Synkinesis Assessment Questionnaire • All patients will be assessed by the Sunnybrook Facial Grading System and House-Brackmann scale to detect degree of synkinesis pre and post treatment • All patients will clinically and medically stable when attending and during the study. • Age will range from 30-60. • Upper motor neuron facial nerve palsy. • History of seizures or fainting. • keratitis, or other ocular diseases • anticoagulant therapy, • Pregnancy, breast-feeding. • Active infection in the area to be treated, neuromuscular junction disorders, or known hypersensitivity to any BoNT-A constituent. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/11/2018 faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zayed Street, Doki Giza Giza 12511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Sunnybrook Facial Grading System before and after completion of sessions
Secondary Outcome The House Brackmann scale before and after completion of sessions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the clinic of faculty of physical therapy 7 Ahmed El Zayed Street, Dooki, Giza,Eygpt Giza 12511 Egypt
the clinic of El Qasr El Einy hospital El-Qasr el Einy street, Giza,Eygpt Giza 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sarah Gaber Mohamed 26 Atbra EL-Mohandessen Giza 12511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 cairo university steet giza 12511 Egypt University
Primary Sponsor faculty of physical therapy 7 Ahmed El Zayed Street,Dooki Giza 12511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Gehan Mousa Ahmed 7 Ahmed El Zayed Street, Doki Giza 12511 Egypt
Dr. Walaa Mohammed Abd El Aziz 7 Ahmed El Zayed Street, Doki Giza 12511 Egypt
Dr. Amr Hassan Elsayed Mohamed 87 El Manyal Al Gharbi Cairo 11311 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gehan Mousa gehannour@gmai.com 002701067841415 7 Ahmed El Zayed Street, Doki Giza
City Postal code Country Position/Affiliation
giza 12511 Egypt cairo university
Role Name Email Phone Street address
Scientific Enquiries Walaa Mohammed Ragab_Walla@yahoo.com 002701093734159 7 Ahmed El Zayed Street, Doki Giza
City Postal code Country Position/Affiliation
Giza 12511 Egypt cairo university
Role Name Email Phone Street address
Public Enquiries Amr Hassan Amrhasanneuro@Kasralainy.edu.eg 002701006060809 87 El Manyal Al Gharbi, Cairo
City Postal code Country Position/Affiliation
Cairo 11511 Egypt Kaser Al Ainy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Participants will be assigned into three groups. Each group will include 15 participants.Group A: Include 15 patients will receive biofeedback electromyography training to control Synkinesis and facial asymmetry. Group B: Include 15 patients will receive BTX-A by neurologist to control Synkinesis and facial asymmetry.Group C:Include 15 patients will receive selected physical therapy program. Informed Consent Form,Statistical Analysis Plan,Study Protocol Participants will receive three sessions per week for 24 sessions along two months of approximately 30-minute to one hour duration and will perform mirror biofeedback as home training. EMG biofeedback, botulinum toxin A, facial synkinesis, facial asymmetry, Bell’s palsy.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided Informed Consent Form,Statistical Analysis Plan,Study Protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information