Comparison of the effect of mirror therapy and modified constraint-induced movement therapy on upper extremity motor function in stroke patients
Design
Randomized clinical trial with control group, double blind, in each group n=14
Settings and conduct
This study will be performed in SBMU Hospital.
Subjects will be selected from stroke patients and randomly allocated in 3 groups.
They do not inform from each other intervention and will be assessed by a therapist who do not aware from intervention type.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Inclusion is voluntary; Age 75-18 years; Diagnosis of stroke; brunnstrom stage 4 and above, Enough cognitive ability to understand and carry out verbal and practical orders; Modified Ashworth Scale less than 3; Existence of at least 20 degrees of wrist extension and 10 degree extension of fingers
Exclusion criteria: Use of mirror therapy or constraint-induced before intervention; Receiving simultaneously another services; Presence any disease in upper limb; Pain greater than 4 In Visual Analog Scale; Botox injection at least 3 months before the intervention
Intervention groups
Intervention group -Modified Constraint-Induced Therapy: intervention
performs 1 hour per day, 5 days per week, for a total of 4 weeks. The intervention sessions include performing tasks with upper limb. In addition to occupational therapy sessions the participants will be asked to wear mitts and do functional tasks.
Intervention group -Mirror therapy: performs 1 hour per day, 5 days per week, for a total of 4 weeks. After adjusting the mirror, the image reflection of non-affected upper limb will be used in the mirror.
Control group: common occupational therapy upper limb interventions that include Bobath, Rood and PNF Techniques will perform for 1 hour per day, 5 days per week, for a total of 4 weeks.
Main outcome variables
Upper extremity function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180526039856N1
Registration date:2018-10-10, 1397/07/18
Registration timing:prospective
Last update:2018-10-10, 1397/07/18
Update count:0
Registration date
2018-10-10, 1397/07/18
Registrant information
Name
Shiva Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0083
Email address
sh.abedi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-27, 1397/08/05
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
"Comparison of the effect of mirror therapy and modified constraint-induced movement therapy on upper extremity motor function in stroke patients"
Public title
"The mirror therapy and modified constraint-induced movement therapy on treatment of upper limb stroke patients"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion is voluntary (completed consent form)
Age range 75-18 years
Ischemic or hemorrhage stroke diagnosed by neurologist
Stage 4, 5 and 6 Brunnstrom in proximal and distal of upper extremities
Sufficient cognitive ability to understand and execute verbal and practical commands (obtaining at least 22 score from the Mini-Mental Status Examination)
Mild spasticity in all involved upper limb joints (Modified Ashworth Scale less than 3)
Existence at least 20 degrees wrist extension and 10 degrees extension of the affected fingers
Exclusion criteria:
Use of mirror therapy and modified constraint-induced movement therapy before intervention
Refer to other clinics and receive other upper limb rehabilitation services
Despite previous dementia, difficulty understanding given explanations and execute commands such as Wernicke aphasia, global aphasia, and any impairment of vision and hearing examinations by specialist
Presence of musculoskeletal damage, frozen shoulder joint and any other neurological and orthopedic disease based on examination of specialist who leads to motion impairment.
Excessive pain in the upper limb ( in this study the score more than 4 in the Visual Analog Scale to be regarded as pain))
Botox injections at least 3 months before the intervention
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized with use of random number table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants do not inform about interventions present to each other. Assessor varies with the person who intervenes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2018-01-13, 1396/10/23
Ethics committee reference number
IR.USWR.REC.1396.284
Health conditions studied
1
Description of health condition studied
stroke patients
ICD-10 code
VI
ICD-10 code description
Diseases of the nervous system
Primary outcomes
1
Description
"Upper extremity score based on Fugl-Meyer Assessment "
Timepoint
"Before the intervention, after the intervention, one month after the intervention."
Method of measurement
"Fugl-Meyer Assessment"
Secondary outcomes
1
Description
"functional independence score"
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
"Functional Independence Measure"
2
Description
"Muscle Tone Score"
Timepoint
"Before the intervention, after the intervention, one month after the intervention."
Method of measurement
"Modify Ashworth Scale"
Intervention groups
1
Description
Intervention group 1: intervention performs 1 hour per day, five days per week, for a total of four weeks. The intervention sessions include performing tasks with upper limb. In addition to occupational therapy sessions the participants in this group will be asked to wear mitts and do functional tasks.
Category
Rehabilitation
2
Description
Intervention group 2: intervention performs 1 hour per day, five days per week, for a total of four weeks. After adjusting the mirror, the image reflection of non-affected upper limb will be used in the mirror so that patient is placed in a sitting position and mirror is placed in front of the non-affected upper limb and patient focuses on the image inside the mirror while practicing.
Category
Rehabilitation
3
Description
Control group: common occupational therapy upper limb interventions that include Bobath, Rood and PNF Techniques will perform for 1 hour per day, five days per week, for a total of four weeks.
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Massoud Arab Loodaricheh
Street address
Koodakyar Ave, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0039
Fax
+98 21 2218 0039
Email
am.arabloo@uswr.ac.ir
Web page address
http://researchdeputy.uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Shiva Abedi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
Email
sh.abedi@uswr.ac.ir
Web page address
http://ot.uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Nazila Akbarfahimi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0063
Email
na.akbarfahimi@uswr.ac.ir
Web page address
http://ot.uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Shiva Abedi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Email
sh.abedi@uswr.ac.ir
Web page address
http://ot.uswr.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Statistical outcomes include MD, SD
When the data will become available and for how long
"From article acceptation"
To whom data/document is available
"Practitioners and students"
Under which criteria data/document could be used
"Use of data with permission"
From where data/document is obtainable
Dr Nazila Akbarfahimi, Assistant professor of University of Social Welfare and Rehabilitation Sciences
Address: Kodakyar Ave, Daneshjo Blvd, Evin
Email: na.akbarfahimi@uswr.ac.ir
Zip Code: 1985713834
Tel: 00982122180063
What processes are involved for a request to access data/document