Protocol summary

Summary
This study will evaluate the effects of mirror therapy on motor ability of patients with stroke. The patients who take 1 to 4 point from Brunnstrom scale, dont have severe cognitive disorders and are able to follow simple verbal instructions (MMSE score>24) will enroll in this study. The patients will exclude if they don’t participate 4 sessions intermittently or 2 sessions constantly in intervention. The 93 of patients randomly will be divided into 3 groups: the mirror therapy group, non reflection surface group and control group. All of groups will participate in a conventional physiotherapy program .but the mirror therapy group will exercise in front of the mirror and also the non reflection group will do the same exercises in front of the surface which is similar to the wood . Both of two groups will exercise 3 days a week, 30 minutes a day and 20 sessions. Outcomes that will be measured، before the intervention, at the end of sessions, 5, 10, 15 and 20 include: motor recovery (Brunnstrom scale), the ability to walk (FAC scale) and performance of daily activities (Barthel scale).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504224787N5
Registration date: 2015-08-01, 1394/05/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-01, 1394/05/10
Registrant information
Name
Tahereh Khaleghdoost Mohammadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1555 5058
Email address
khaleghdoost@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Guilan University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of mirror therapy on motor ability of patients after stroke at a physiotherapy center
Public title
The effect of mirror therapy on motor ability of patients after stroke
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: patients with age between 30 to 65 y/o, with the first-ever stroke that are diagnosed by neurologists and confirmed by computed tomography or magnetic resonance imaging. One month has passed from their stroke, to take 1 to 4 point from Brunnstrom scale, not to have severe cognitive disorders and be able follow simple verbal instructions (MMSE score>24).Exclusion criteria: the patients will exclude if they don’t participate 4 sessions intermittently or 2 sessions constantly in intervention.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Guilan university of Medical Sciences
Street address
Namjoo Street
City
Rasht
Postal code
4193893345
Approval date
2015-04-27, 1394/02/07
Ethics committee reference number
IR.GUMS.REC.1394.11

Health conditions studied

1

Description of health condition studied
cerebral vascular disease
ICD-10 code
Z50.1
ICD-10 code description
Other physical therapy Therapeutic and remedial exercises

Primary outcomes

1

Description
Motor abillity
Timepoint
Before intervention and the end of 5,10,15 and 20 sessions
Method of measurement
Brunnstrom recovery movement tool, Functional Ambulation Classification and Barthel selfcare questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Physical training routine
Category
Rehabilitation

2

Description
Training 30 minutes more than routine physiotherapy practices in front of the mirror
Category
Rehabilitation

3

Description
Training 30 minutes more than routine physiotherapy practices in front of the M.D.F
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy center for elderly and handicap city of Rasht
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Street address
Entezam Square, Maloolin Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Science
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshi Highway
City
Rasht
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 of Guilan University of Medical Science
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
Shahid Beheshti Faculty of Nursing and Midwifery
Full name of responsible person
Maryam Shabani Mehr
Position
Student of Master science of critical care nursing
Other areas of specialty/work
Street address
Yakhsazi, Daneshjoo Blvd
City
Rasht
Postal code
Iran
Phone
+98 13 3355 5056
Fax
Email
shabanimehr1989@gmail.com
Web page address
ghazaleh.mehr1988@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
Master Science of Nursing
Other areas of specialty/work
Street address
Yakhsazi, Daneshjoo Blvd
City
Rasht
Postal code
Iran
Phone
+98 13 3355 5056
Fax
Email
khaleghdoost@gums.ac.ir khaleghdoost@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti faculty of midwifery and nursing
Full name of responsible person
Tahereh Khaleghdoost Mohammadi
Position
Master science of nursing
Other areas of specialty/work
Street address
Yakhsazi, Daneshjoo Blvd
City
Rasht
Postal code
Iran
Phone
+98 13 3355 5056
Fax
Email
khaleghdoost@gums.ac.irkhaleghdoost@yahoo.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
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