Investigating the effect of rTMS therapy concomitant with rehabilitation on motor deficit of upper extremities of TBI patients in comparison to rehabilitation alone
this project is about treatment of TBI patients with combination of rTMS and rehabilitation and rehabilitation alone and investigating the effect of these tretments on upper extremitiy disability and hand grip,we have 2 groups and each group contains 7patients who selected randomized,the first group gets rehabilitation plus not real rTMS and the second group gets rehabilitation and real rTMS.before starting the treatments,exactly after that and then 3 weeks later we evaluate and compare the results of grip and questionnaire.
this project is double blinded for patients and doctors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011932053N1
Registration date:2017-03-28, 1396/01/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Raziyeh Shiravani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 7477
Email address
shirvanira@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-09-01, 1395/06/11
Expected recruitment end date
2016-12-03, 1395/09/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of rTMS therapy concomitant with rehabilitation on motor deficit of upper extremities of TBI patients in comparison to rehabilitation alone
Public title
Investigating the effect of rehabilitation with and without rTMS (repetitive transcranial magnetic stimulation) on upper extremity motor deficit of traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:motor deficit at least in one upper extremity,passes a month from TBI,muscle power less than or equal to 4,cooperation of the patient in therapeutic sessions,contusion of motor cortex in CT Scan
Exclusion criteria:musculoskeletal injury,bone fracture,co-existing neurological diseases like MS,limited mobiblity not due to traumatic brain injury,history of epilepsy-arrhythmia in family or himself,having implant,pacemaker or clips in brain
Age
From 23 years old to 52 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
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
Ethic committee of Shiraz University of Medical Sciences
Street address
Building of the Central University of Medical Sciences, across the Palastinian street, Zand Street, Shiraz
City
Shiraz
Postal code
7134814336
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.SUMS.REC.1395.179
Health conditions studied
1
Description of health condition studied
brain injury
ICD-10 code
S06.3, S06
ICD-10 code description
focal brain injury,Other intracranial injuries
2
Description of health condition studied
motor deficit
ICD-10 code
v01-x59
ICD-10 code description
accidents
Primary outcomes
1
Description
brain injury
Timepoint
before treatment
Method of measurement
sign,symptoms,CT scan
2
Description
motor deficit
Timepoint
before tretment, at the end, 3 weeks later
Method of measurement
dinamometer
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: treatment with rTMS with high frequency(10HZ),20 minutes for each 10 sessions (3 sessions in a week) and rehabilitation(physiotherapy and excercise) for 10 sessions and each sessions has 40 minutes.
Category
Treatment - Other
2
Description
control group: rehabilitation (physiotherapy and excercise) for 10 sessions and each sessions has 40 minutes and false rTMS 20 minutes for each 10 sessions (3 sessions in a week)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Hospital
Full name of responsible person
Sharareh Roshanzamir
Street address
Rajai Hospital, not far from the Niyayesh boulevard, Chamran boulevard, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Street address
Building of the Central University of Medical Sciences, across the Palestinian street, Zand Street, Shiraz
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
assistant professor, specialist of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Building of the Central University of Medical Sciences, across the Palestinian street, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
sharareh.roshanzamir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Assistant professor, specialist in physical medicine & rehabilitation
Other areas of specialty/work
Street address
Building of the Central University of Medical Sciences, across the Palestinian street, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
sharareh.roshanzamir@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh Roshanzamir
Position
Assistant professor, specialist in physical medicine & rehabilitation
Other areas of specialty/work
Street address
Building of the Central University of Medical Sciences, across the Palestinian street, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3231 9040
Fax
Email
sharareh.roshanzamir@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)