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Management of synkinesis with a combination of BTX-A and biofeedback: A randomized trial

Protocol summary

Summary
Abstract Objective: The aim of this study was to investigate the efficacy of combination of biofeedback and BTX-A injection for management of synkinesis. Among referral patients from three university hospitals.Inclusion criteria is Bell' palsy with synkinesis and exclusion criteria is hami facial spasm. Thirty four patients with facial synkinesis are divided randomly into 2 groups. All the participants were evaluated by videotape and facial grading system. The first group as a Botox group, received single dose of BTX-A (Dysport) in the initiation of treatment. The second group received Normal Saline as control group. Both groups received EMG biofeedback 3 sessions in a week for 4 months

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309256083N3
Registration date: 2013-10-07, 1392/07/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-07, 1392/07/15
Registrant information
Name
Abbas Ali Pourmomeny
Name of organization / entity
School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2024
Email address
pourmomeny@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Center of Isfahan University of Medical Sciences
Expected recruitment start date
2012-04-21, 1391/02/02
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Management of synkinesis with a combination of BTX-A and biofeedback: A randomized trial
Public title
Management of synkinesis with a combination of BTX-A and biofeedback
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Bell' palsy with synkinesis Exclusion criteria: hami facial spas
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
symetric face muscles

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Committee Medical Ethics of the "Isfahan University of medical Sciences"
Street address
Committee for Medical Ethics of the "Isfahan University of medical Sciences"
City
Isfahan
Postal code
Approval date
2012-09-23, 1391/07/02
Ethics committee reference number
392390

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
synkinesis
Timepoint
before and after treatment videotape
Method of measurement
videotape & facial grading system

Secondary outcomes

empty

Intervention groups

1

Description
Botox-A
Category
Treatment - Drugs

2

Description
biofeedback therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Sciences of " Isfahan University of Medical Sciences"
Full name of responsible person
Pourmomeny
Street address
Rehabilitation Sciences of "Isfahan University of Medical Sciences"
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Center of research of Medical Sciences of "Isfahan University"
Full name of responsible person
Adibi
Street address
Center of research of Medical Ethics of the "Isfahan University of Medical Sciences"
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Center of research of Medical Sciences of "Isfahan University"
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
Department of physical therapy, School of Rehabilitation Sciences, "Isfahan University of Medical Sc
Full name of responsible person
pourmomeny
Position
Instctor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences," Isfahan University of Medical Sciences"
City
Isfahan
Postal code
Phone
+98 31 1792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Sciences, "Isfahan University of Medical Sciences"
Full name of responsible person
pourmomeny
Position
Msc
Other areas of specialty/work
Street address
Department of physical therapy, School of Rehabilitation Sciences, "Ishahan University of Medical Sciences"
City
Isfahan
Postal code
Phone
+98 31 1792 2024
Fax
Email
pourmomeny@rehab.mui.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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