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A clinical trial on the effect of mirror therapy in comparison with routine physiotherapy on motor abilities of patients with stroke patients

Protocol summary

Summary
Hemiparesis and hemiplegia are the most common and the worse complications of stroke. This study aimed to observe the effect of mirror therapy on motor abilities of patients with stroke in Mashhad, Iran. In this Randomized Control Trial, 40 patients with stroke (more than 1 month after the last stroke) will be assigned randomly in two groups of mirror therapy (n=20) and control (n=20). The inclusion/ exclusion criteria will be age of 30-65 years old, score of 1-3 from motor recovery index, lack of cognitive, verbal and visual disorder, recurrence of stroke or any problem responsible for stopping rehabilitation program. Intervention will be include 20 sessions of 30-minute mirror therapy, i.e. will perform flexion and extension of upper and lower extremities of affected and healthy ones in front of mirror and observe just the mirror image. In addition to mirror therapy in both groups, the routine program (physiotherapy and neuromuscular stimulation) will be performed. Upper and lower extremity motor abilities will be assessed before, during and after treatment using motor recovery scale, function Index Measure, Function Ambulation Classification, Barthel Index Scale and the range of motion will be measured by goniometry then two groups will compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204289575N1
Registration date: 2013-03-22, 1392/01/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-03-22, 1392/01/02
Registrant information
Name
Mahnaz Bahrami
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1842 1744
Email address
bahramim901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the effect of mirror therapy in comparison with routine physiotherapy on motor abilities of patients with stroke patients
Public title
The effect of mirror therapy on rehabilitation of stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. At least 1 month after stroke. 2. Conducting routine rehabilitation program. 3. Score of 1-3 from motor recovery index. 4. No severe cognitive, verbal and visual disorder, history of dementia, Global aphasia or any visual disorder based on neurologist examination. 5. First experience of stroke. 6. No disease resulting in motor defects. Exclusion criteria: 1. Repetitive stroke. 2. No tendency for continuing rehabilitation program. 3. Any disease such as hemi anesthesia, trauma, severe infection, etc which cause to stop rehabilitation program. 4. Absent in 4 intermittent sessions or 2 subsequent sessions of course.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Coin dropping will be use for random assignment in two groups of intervention and control. i.e. the clients with first session of physiotherapy in odd days will be assigned to test group and the others whose first session in even days will be assigned to control group.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St. Doktora Crossroads.
City
Mashhad
Postal code
9137913199
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
91/563419

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
167.9
ICD-10 code description
Cerebrovascular disease, unspecified

Primary outcomes

1

Description
motor ability of upper extremity
Timepoint
before, 5th, 10th, 15th and last sessions of intervention
Method of measurement
Goniometry, Barthel Index Scale, Motor Recovery Index.

2

Description
motor ability of lower extremity
Timepoint
before, 5th, 10th, 15th and last sessions of intervention
Method of measurement
Goniometry, Function Ambulation Classification, Barthel Index Scale, Function Index Measure, Motor Recovery Index.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention will be 20 sessions of 30-minute mirror therapy, i.e. flexion and extension of upper and lower extremities of affected and healthy ones in front of mirror and observe just the mirror image. Upper and lower extremity motor abilities will be assessed before, at 5th, 10th, 15th and last sessions of intervention using motor recovery scale, function Index Measure, Function Ambulation Classification, Barthel Index Scale and the range of motion will be measured by goniometry.
Category
Rehabilitation

2

Description
Control group will perform all physiotherapy exercises of upper and lower extremities without mirror.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy unit of Quaem Hospital
Full name of responsible person
Mohammad Javad Zarandi
Street address
Beginning of Ahmadabad Ave. Dr. shariati Sq.
City
Mashhad

2

Recruitment center
Name of recruitment center
Physiotherapy unit of Emam Reza Hospital
Full name of responsible person
Abbas Ramezani
Street address
Emam Reza Sq. Ebne Sina Ave.
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Faculty of Nursing and Midwifery, Ebn-e Sina St. Doktora Crossing,
City
Mashhad
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, Mashhad 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
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mahnaz Bahrami
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
bahramim901@mum.ac.ir; bahrami_mb_66@yahoo.com; bahramim901@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Seyed Reza Mazlom
Position
PhD
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing, Daneshgah Ave.
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
mazlomr@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Faculty of Nursing and Midwifery
Full name of responsible person
Mahnaz Bahrami
Position
MS Nursing/Postgraduate student
Other areas of specialty/work
Street address
Ebn-e Sina St. Doktora Crossing, Daneshgah Ave.
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
bahramim901@mums.ac.ir; bahrami_mb_66@yahoo.com; bahramim901@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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