1. Home
  2. Approved trials
  3. » فارسی

Evaluation of Ritaline's effect on improvement of motor function in patient with acute ischemic stroke

Protocol summary

Summary
Aims: To determine the effect of Ritalin on the improvement of motor function in patients with acute ischemic stroke, Design: This was a randomized, double-blind trial on 60 patients with acute ischemic stroke who referred to Imam Reza Hospital from Kermanshah, Setting and conduct: After obtaining satisfaction, patients were randomly divided into two groups, separated by a nurse in the placebo group or Ritalin, In addition, both groups are simultaneously undergoing physiotherapy at the same time. Once patients before treatment, then the end of my second week and after treatment, according to the FMS are evaluated performance motion systems, Participants: According to the findings of the physical examination and imaging devices (Brain CT) by a neurologist for their acute ischemic stroke is characterized, Intervention: patients in the intervention group were given capsules containing 10mg Ritalin, and control group were given capsule which closely resemble capsules containing Ritalin drugs for 14 days, main outcome variable: the ability to movement on the basis of FMS in patients before treatment, 2 weeks and 10 weeks after starting treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404101856N4
Registration date: 2015-05-03, 1394/02/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Dariush Afshari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 0177
Email address
dafshari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ritaline's effect on improvement of motor function in patient with acute ischemic stroke
Public title
Effect of Ritaline's on motor function in patients with acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with acute ischemic stroke; signed informed consent form and a questionnaire. Exclusion criteria: patients younger than 45 years (due to the low prevalence CVA) and for different reasons of CVA; patients with GCS <12; people who are allergic to Ritalin; with glaucoma; people with brainstem stroke and stroke cerebeller; who have dementia; with Psychosis; Unstable Arrhythmia; CHF; Unstable Angina; those already have used drugs MAOI and drugs agonists or antagonists, α-adrenergic , who already had CVA and the CVA this problem because they have a disability previous neurological deficit, those based on FMS, score 80-100 have received.
Age
From 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Kermanshah University of Medical Sciences Ethics Committee
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Bolvar, Kermanshah
City
Kermanshah
Postal code
Approval date
2013-11-05, 1392/08/14
Ethics committee reference number
34187

Health conditions studied

1

Description of health condition studied
Acute ischemic stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Motor function
Timepoint
Before the intervention, 2 weeks after the intervention, 10 weeks after intervention
Method of measurement
Based on the criteria for FMS

Secondary outcomes

empty

Intervention groups

1

Description
Ritalin, 10 mg capsules orally, once daily for 14 days
Category
Treatment - Drugs

2

Description
Placebo, 10 mg capsules orally, once daily for 14 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Nafar
Street address
Departement of Norologic, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Building No. 2 of Kermanshah University of Medical Sciences, Shahidbeheshti Bolvar
City
Kermanshah
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, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Arash Bostani
Position
MD, Neurologist
Other areas of specialty/work
Street address
Departement of Norologic, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
arashbostani2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Darioush Afshari
Position
MD, Neurologist
Other areas of specialty/work
Street address
Departement of Norologic, Imam Reza Hospital, Sorkhalizheh
City
Kermanshah
Postal code
Phone
+98 83 3428 2668
Fax
Email
afshari-d@yahoo .com; dafshari@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Nafar
Position
MD, resident of Neurology
Other areas of specialty/work
Street address
Department of Pediatrics, Mohammad Kemanshahi Hospital, Helal Ahmar Ave, Kermanshah
City
Kermanshah
Postal code
Phone
Fax
Email
drmnafar@gmail.com
Web page address

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
Loading...