Protocol summary
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Study aim
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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.
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Design
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The effect of transcranial direct current electrical stimulation and motor exercises on stroke patients, with control group, double blind, non-random
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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transcranial Direct Current Stimulation and motor
exercises
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Main outcome variables
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Grip strength of the patients' hand
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-05-27, 1399/03/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-22, 1398/09/01
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Expected recruitment end date
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2021-03-19, 1399/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Transcranial Direct Current Stimulation combined with simultaneous motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
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Public title
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Transcranial Direct Current Stimulation combined with simultaneous motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 24 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
24
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-13, 1398/07/21
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Ethics committee reference number
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IR.IUMS.REC.1398.726
Health conditions studied
1
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Description of health condition studied
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Transcranial Direct Current Stimulation with motor exercises to reduce the time to recover the grip strength in stroke patients with motor deficient
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ICD-10 code
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G46.3
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ICD-10 code description
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Brain stem stroke syndrome
Primary outcomes
1
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Description
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improvement in gripping speed and strength
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Timepoint
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Before intervention - after 10 sessions of intervention
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Method of measurement
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Dynamometer Grip Devices
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Project Manager of Simulator Systems Lab
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available