Evaluation of the effect of mirror therapy on motor ability of patients with stroke referred to the neurology department of Imam Reza hospital of Kermanshah
Investigation of the effect of mirror therapy on motor ability of patients with stroke referred to the neurology department of Imam Reza hospital of Kermanshah
Design
This study is a not blinded clinical trial. The study population included all patients with stroke referring to Imam Reza hospital of Kermanshah city.64 eligible patients will be selected conveniently and randomly assigned to intervention and control groups.
Settings and conduct
The participants and the researcher will know which group will be under the mirror therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:People with stroke diagnosed by a neurologist based on the results of CT scans and MRI; At least 1 month passed from the time of the occurrence of stroke
Exclusion criteria:Recurrence of stroke
Intervention groups
In the intervention group, in addition to the usual rehabilitation program,the mirror treatment will be performed in the morning shifts for 20 sessions of 30 minutes per day, and for each upper and lower limb, 15 minutes for each limb.
In the control group, only the usual rehabilitation program will be conducted by a rehabilitation specialist with a researcher's control for 20 sessions of 30 minutes in the morning shifts.
Main outcome variables
Motor function; walking ability; motor recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N88
Registration date:2018-03-14, 1396/12/23
Registration timing:prospective
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of mirror therapy on motor ability of patients with stroke referred to the neurology department of Imam Reza hospital of Kermanshah
Public title
The effect of mirror therapy on motor abilities of patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with stroke diagnosed by a neurologist based on the results of CT scans and MRI
At least 1 month passed from the time of the occurrence of stroke
No any known disease causing motor defects, such as MS, Parkinson's, Myopathy, Arthritis and ...
Exclusion criteria:
Recurrence of stroke
Unwillingness to continue the rehabilitation program
Having diseases that prevent a person from performing a rehabilitation program (such as trauma, severe infection)
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization by random number table via code receipt
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-07-19, 1396/04/28
Ethics committee reference number
KUMS.REC.1396.195
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I63.5
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries
Primary outcomes
1
Description
Motor function
Timepoint
The beginning and end of the study
Method of measurement
Based on Function Index Measure(FIM)
2
Description
The ability to walk
Timepoint
The beginning and end of the study
Method of measurement
Based on the questionnaire Function Ambulation Categories(FAC)
3
Description
Motion recovery (brunnstrom)
Timepoint
The beginning and end of the study
Method of measurement
Based on the questionnaire Brunnstorm
4
Description
Self care
Timepoint
The beginning and end of the study
Method of measurement
Based on Barthel Index Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, in addition to the usual rehabilitation program,the mirror treatment will be performed in the morning shifts for 20 sessions of 30 minutes per day, and for each upper and lower limb, each limb for 15 minutes
Category
Other
2
Description
In the control group, only the usual rehabilitation program will be conducted by a rehabilitation specialist with a researcher's control for 20 sessions of 30 minutes in the morning shifts.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Maryam Janatmakan
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Maryam.Janatmakan@kums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Janatmakan
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Maryam.Janatmakan@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Kamran Vafaee
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
k.vafaee60@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Maryam Janatmakan
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
Maryam.Janatmakan@kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
3 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
En In a 25-day period, the documents will be sent e-mail