Transcranial Direct Current Stimulation combined with simultaneous motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Recruitment centers
#1
Name of recruitment center - English: hospital emam
Name of recruitment center - Persian: ----
Full name of responsible person - English: Mohammad Rostami
Full name of responsible person - Persian: محمد رستمی
Street address - English: ---------
Street address - Persian: -------------
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115-111
Phone: +98 21 8288 3904
Fax:
Email: M-Rostami@modares.ac.ir
Web page address:
Name of recruitment center - English: Firouzgar Hospital
Name of recruitment center - Persian: بیمارستان فیروزگر
Full name of responsible person - English: Dr. Masoud Mehrpour
Full name of responsible person - Persian: دکتر مسعود مهرپور
Street address - English: Firouzgar Hospital, beh afarin st., karimkhan ave.
Street address - Persian: خیابان کریم خان- خیابان به آفرین- بیمارستان فیروزگر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 47811-15936
Phone: +98 21 8214 1771
Fax:
Email: mehrpr@yahoo.com
Web page address:
Name of recruitment center - English: hospital emamFirouzgar Hospital Name of recruitment center - Persian: ----بیمارستان فیروزگر Full name of responsible person - English: Mohammad RostamiDr. Masoud Mehrpour Full name of responsible person - Persian: محمد رستمیدکتر مسعود مهرپور Street address - English: ---------Firouzgar Hospital, beh afarin st., karimkhan ave. Street address - Persian: خیابان کریم خان- خیابان به آفرین------------ بیمارستان فیروزگر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411547811-11115936 Phone: +98 21 8288 39048214 1771 Fax: Email: M-Rostamimehrpr@modares.ac.iryahoo.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: The University of Tarbiat Modares
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Mohammad Rostami
Full name of responsible person - Persian: محمد رستمی
Street address - English: Tehran Jalal AleAhmad Nasr P.O.Box: 14115-111
Street address - Persian: بزرگراه جلال آل احمد - پل نصر - دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115-111
Phone: +98 21 8288 3904
Fax:
Email: M-Rostami@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Simulation systems lab of Tarbiat Modares University
Name of organization / entity - Persian: آزمایشگاه سامانه های شبیه ساز دانشگاه تربیت مدرس
Full name of responsible person - English: Mohammad Rostami
Full name of responsible person - Persian: محمد رستمی
Street address - English: Tehran Jalal AleAhmad Nasr P.O.Box: 14115-111
Street address - Persian: بزرگراه جلال آل احمد - پل نصر - دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14115-111
Phone: +98 21 8288 3904
Fax:
Email: m-rostami@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: The UniversitySimulation systems lab of Tarbiat Modares University Name of organization / entity - Persian: آزمایشگاه سامانه های شبیه ساز دانشگاه تربیت مدرس Full name of responsible person - English: Mohammad Rostami Full name of responsible person - Persian: محمد رستمی Street address - English: Tehran Jalal AleAhmad Nasr P.O.Box: 14115-111 Street address - Persian: بزرگراه جلال آل احمد - پل نصر - دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14115-111 Phone: +98 21 8288 3904 Fax: Email: Mm-Rostamirostami@modares.ac.ir Web page address:
Academic
Persons
academicpersons
The University of Tarbiat Modares
Project Manager of Simulator Systems Lab
The UniversityProject Manager of Tarbiat ModaresSimulator Systems Lab
دانشگاه تربیت مدرس
مدیر پروژه آزمایشگاه سامانه های شبیه ساز
دانشگاه تربیت مدرسمدیر پروژه آزمایشگاه سامانه های شبیه ساز
Protocol summary
Study aim
We want to investigate the effect of tDCS and motor exercises on the patient, which will be measured using the grip strength test and fMRI.
Design
The effect of transcranial direct current electrical stimulation and motor exercises on stroke patients, with control group, double blind, non-random
Settings and conduct
In this study, two methods of tDCS and simultaneous motor exercises will be applied to stroke patients. The motor exercises method, will create a new neural network and the tDCS method provides stability of neural network. Combining these two methods at the same time can reduce the recovery time and thus reduce the medical costs for patients.
Participants/Inclusion and exclusion criteria
Stroke patients with motor dysfunction in the upper extremity.
should not have any metallic objects in their body. also, they should not be over 70 years old and over 100 kilograms, and they should not have claustrophobia.
Intervention groups
transcranial Direct Current Stimulation and motor
exercises
Main outcome variables
Grip strength of the patients' hand
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045665N1
Registration date:2020-05-27, 1399/03/07
Registration timing:registered_while_recruiting
Last update:2020-05-30, 1399/03/10
Update count:1
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Mohammad Rostami
Name of organization / entity
The University of Tarbiat Modares
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3904
Email address
m-rostami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Transcranial Direct Current Stimulation combined with simultaneous motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
Public title
Transcranial Direct Current Stimulation combined with simultaneous motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke patients
Stroke patients suffering from upper extremity dysfunction.
Range of age: 30- 60 years
Exclusion criteria:
Presence of metal objects such as implants, pacemakers, etc. in the patient's body.
The Patient's Weight must be under100 kilograms
The Patient must be under 70 years old
Uncontrolled blood pressure
Age
From 24 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The test is planned in such a way that the participant does not know which of the control group or test groups he/she belongs to. This means that the participant thinks that their treatment method is similar to the rest of the participants. Also, the evaluators only evaluate using fMRI results and are unaware of the treatment process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Jalal AleAhmad Nasr P.O.Box: 14115-111
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.IUMS.REC.1398.726
Health conditions studied
1
Description of health condition studied
Transcranial Direct Current Stimulation with motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
ICD-10 code
G46.3
ICD-10 code description
Brain stem stroke syndrome
Primary outcomes
1
Description
improvement in gripping speed and strength
Timepoint
Before intervention - after 10 sessions of intervention
Method of measurement
Dynamometer Grip Devices
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: After one fMRI session and measuring the grip strength of the patients in this group, 10 treatment sessions of tDCS and motor exercises are performed on them, and then fMRI and the grip strength test are taken again.
Category
Treatment - Devices
2
Description
Second Intervention group: After one fMRI session and measuring the grip strength of the patients in this group, 10 motor exercises sessions were performed on them, and then fMRI and the grip strength test are taken again.
Category
Rehabilitation
3
Description
Control group: After one fMRI session and measuring the grip strength of the patients in this group, 10 Sham-tDCS therapy sessions and motor exercises were performed on them, and then fMRI and the grip strength test were taken again.