In this double-blind, clinical trial, the aim of this study is evaluation of the role of the repetitive transcranial stimulation as an adjuvant therapy in Bell’s palsy. Inclusion criteria: The patients with unilateral Bell’ palsy; aged between 18 to 72 years.
Exclusion criteria: The patients who have severe complications; patients who do not follow up. The sample size in this study is 46, patients will be allocate randomly in two parallel groups. The randomization is do with randomization software and also in this study doctors are blinded about groups. The intervention group are treated with exercise physiotherapy and repetitive transcranial stimulation for 3 seasons/ week, and the placebo group are treated with exercise physiotherapy for 3 seasons/ weeks, the length course of treatment is 2 weeks in both groups. After treatment duration, the recovery rate of patients in the two groups is assessed using facial disability index.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100312782N20
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of the repetitive transcranial stimulation as an adjuvant therapy in Bell’s palsy.
Public title
The effect of the repetitive transcranial stimulation as an adjuvant therapy unilateral facial palsy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients with unilateral Bell’ palsy; aged between 18 to 72 years.
Exclusion criteria: The patients who have severe complications; patients who do not follow up.
Age
From 18 years old to 72 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUI.REC.1395.30035
Health conditions studied
1
Description of health condition studied
Bell's palsy
ICD-10 code
G51.0
ICD-10 code description
Facial palsy
Primary outcomes
1
Description
Facial paralysis
Timepoint
Before intervention and 2 weeks after intervention
Method of measurement
facial disability index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: under Treatment with exercise physiotherapy and repetitive transcranial stimulation in 3 seasons/week
Category
Rehabilitation
2
Description
Control group: under Treatment with exercise physiotherapy in 3 seasons/week
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Al Zahra Hospital
Full name of responsible person
Samira Oshaghi
Street address
Alzahra hospital, Alzahra street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Mansour Siavash
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences, Isfahan
Full name of responsible person
Dr Ahmad Rezaeian
Position
Otorhinolaryngologist/ Assistant professor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
dr.ahmadrezaeian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Samira Oshaghi
Position
Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
Dr.samiraoshaghi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi Koushki
Position
Responsible for Research/Master of Science
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
7346181746
Phone
+98 31 3625 5555
Fax
Email
Mehrabi@mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)