To explore of the effectiveness of motor learning based mirror therapy on the hand function of 7 to 12-year-old children with hemiplegic cerebral palsy
Design
Single-blinded two arm parallel group randomized control trial
Settings and conduct
After obtaining the necessary licenses and submitting them to the relevant centers (Rehabilitation Centers affiliated to Isfahan University of Medical Sciences and Asude Mawa Charitable Association), according to the inclusion and exclusion criteria of the participants, a sampling frame will be prepared. In the next step, among all eligible children, thirty 7 to 12 years old children with unilateral cerebral palsy will selected randomly. After the pre-test, they will be randomly assigned to two groups of mirror therapy based on the principles of motor learning and common mirror therapy (participants, testers, and statistical analysts will be blinded), then the post-test is performed and finally the results are analyzed statistically. In order to follow-up one month after the post-test, participants will be assessed for a third time.
Participants/Inclusion and exclusion criteria
Diagnosis of partial cerebral palsy based on the MACS grading scale, participants have the hand function ability to rank 1 to 3. Having at least intelligence 70 based on the Raven's Colored Progressive Matrices. Health problems unrelated to cerebral palsy. Treatment-resistant epilepsy. Visual problems that interfere with the performance of the intervention or test
Muscle tone above 3.5 (mean for elbow and wrist joint movements) based on modified Ashworth Scale.
Intervention groups
Motor learning based mirror therapy; Common mirror therapy
Main outcome variables
Uni-manual function; bi-manual skills; grasp strength; tactile discrimination; passive range of motion (P-ROM); active range of motion (A-ROM); parent perception; dexterity; bilateral coordination; visual-motor control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200224046604N1
Registration date:2020-03-15, 1398/12/25
Registration timing:prospective
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Hossein Sourtiji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5094
Email address
sourtiji@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-04-24, 1399/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of motor learning based mirror therapy on the hand function of 7 to 12-year-old children with hemiplegic cerebral palsy
Public title
Effect of mirror therapy on hand of children with cerebral oalsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of partial cerebral palsy
Based on the MACS grading scale, participants have the hand function ability to rank 1 to 3.
Having at least intelligence 70 based on the Raven's Colored Progressive Matrices
Exclusion criteria:
Health problems unrelated to cerebral palsy
Treatment-resistant seizures
Visual problems that interfere with the intervention or test.
Muscle tone above 3.5 (mean for elbow and wrist joint movements) based on modified Ashworth Scale
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Sealed envelopes. Participants will choose one envelope between two separate envelopes. It is noteworthy that in each envelope there is a sheet in which the name of one of the groups is written.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, data analyzer, and outcome elevator will not know which of the participants belonged to the intervention group and which one was in the comparison group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The institutional research ethics committee of vice-chancellor of Isfahan University of medical scie
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.618
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
G81
ICD-10 code description
Hemiplegia and hemiparesis
Primary outcomes
1
Description
Hand function
Timepoint
Before the intervention, after the intervention, one month after the post-test
Method of measurement
Bruininks-Oseretsky test of motor proficiency, Jebsen–Taylor Hand Function Test
Secondary outcomes
1
Description
Grasp strength
Timepoint
Before the intervention, after the intervention, one month after the post-test
Method of measurement
Vigorimeter
2
Description
Two-point discrimination
Timepoint
Before the intervention, after the intervention, one month after the post-test
Method of measurement
Two-point discrimination scale
3
Description
Active and passive range of motion
Timepoint
Before the intervention, after the intervention, one month after the post-test
Method of measurement
Goniometry
4
Description
Parent perception
Timepoint
Before the intervention, after the intervention, one month after the post-test
Method of measurement
Caregiver Functional Use Survey (CFUS)
5
Description
Visual motor coordination
Timepoint
Caregiver Functional Use Survey (CFUS)
Method of measurement
Bruininks-Oseretsky test of motor proficiency
Intervention groups
1
Description
Intervention group: Motor learning based mirror therapy that is designed based on the principles of motor learning including behavior shaping, types and grading of the tasks and types of practice. Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week.
Category
Rehabilitation
2
Description
Control group: Common mirror therapy intervention consists of 3 repetitions of 10 sets of 7 symmetrical motor tasks and simultaneously upper limb and hand. Exercises include fine motor exercises, full range of motion exercises, and finger and forearm strength exercises.Intervention protocol will consist of twenty 30-45 minute sessions for 7 weeks and 3 sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation faculty, Isfahan University of medical sciences
Full name of responsible person
Hossein Sourtiji
Street address
Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5049
Email
sourtiji@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical sciences Hezar Jarib Ave
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Sourtiji
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science Faculty Isfahan University of Medical sciences Hezar Jarib Ave, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5049
Email
sourtiji@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Sourtiji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science Faculty Isfahan University of Medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5049
Email
sourtiji@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Sourtiji
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Rehabilitation Science Faculty Isfahan University of Medical sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5049
Email
sourtiji@rehab.mui.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 indicators related to the total data
When the data will become available and for how long
Start of access period from 2022
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If data is needed for systematic review (meta-analysis) studies.
From where data/document is obtainable
Hossein Sourtiji
Occupational therapy department, Rehabilitation sciences faculty, Isfahan University of medical sconces
00983137925049
What processes are involved for a request to access data/document
Request from the applicant's person or organization
Approved by the President of the University,
Approved by the head of the faculty