Statement of the purpose: The main purpose of this single-subject experiment will be to examine whether mirror therapy could improve the functional status of the spastic hand in hemiplegic cerebral palsy children.
Inclusion criteria: Spastic hemiplegic cerebral palsy; age ranges between 5-15 year-old; cognitively normal; intact visual and hearing ability; no intervention with botulinum toxin during the last 6 months prior to the study; willingness of child and parents to participate in the study.
Exclusion criteria: Unwillingness of child or their parents to continue cooperation with the researchers; any reason leading the participant to be unable to continue such as admitting to hospital or getting sick.
Study population and sample size: The study population will be 4 hemiplegic cerebral palsy children.
Intervention and primary outcomes: This study involves three observational phases known as baseline, treatment, and withdrawal phase, taking place during a two months period. The study contains a home-based mirror therapy protocol that will be the manipulated variable, by which the participants will be taught to do some exercises on a daily basis. The improvement of the hand functional status of the hemiplegic side will be the dependent variable examined by Jebson-Taylor hand function test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012080410491N1
Registration date:2016-08-30, 1395/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-30, 1395/06/09
Registrant information
Name
Seyed Alireza Derakhshanrad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
derakhshan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-05-01, 1395/02/12
Expected recruitment end date
2017-01-01, 1395/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mirror therapy on improving the hand function in hemiplegic children
Public title
Effectiveness of mirror therapy on improving the hand function in hemiplegic children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Spastic hemiplegic cerebral palsy; age ranges between 5-15 year-old; cognitively normal; intact visual and hearing ability; no intervention with botulinum toxin during the last 6 months prior to the study; willingness of child and parents to participate in the study
Exclusion criteria: unwillingness of child or their parents to continue cooperation with the researchers; any reason leading the participant to be unable to continue such as admitting to hospital or getting sick
Age
From 5 years old to 15 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Postal code
Approval date
2015-07-12, 1394/04/21
Ethics committee reference number
IR.SUMS.REC.1394.73
Health conditions studied
1
Description of health condition studied
Spastic hemiplegia
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Functional status of affected hand
Timepoint
Two times in the baseline phase - Three times in the treatment phase - Two times after withdrawing the treatment phase
Method of measurement
Box and block test
Secondary outcomes
1
Description
Hand dexterity
Timepoint
Two times in the baseline phase - Three times in the treatment phase - Two times after withdrawing the treatment phase
Method of measurement
A fuctional test of beads threading
Intervention groups
1
Description
This will be the ABA single-subject design involving observation of a single participant during three phases known as A, B, and A:
A) This is a baseline phase lasting for two weeks in which the established functional status of spastic hemiplegic hand will be assessed only by Jebson-Taylor hand function test.
B) This is a treatment phase lasting for 6 weeks in which the therapy will be provided and meanwhile the assessment will be continued. A home-based mirror therapy will be taught to participants who should be totally committed to perform it on a daily basis.
A) In this last phase lasting for 2 weeks, the treatment will be withdrawn, but the assessment will be continued.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz School of Rehabilitation Sciences
Full name of responsible person
Seyed Alireza Derakhshanrad
Street address
Shiraz School of Rehabilitation Sciences, Abiverdi 1, Chamran Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sobhan Sobhani
Street address
Shiraz Shcool of Rehabilitation Sciences, Abiverdi 1, Chamran Blvd
City
Shiraz
Grant name
Grant code / Reference number
93-01-06-8984
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Derakhshanrad
Position
PhD/Assistant Professor
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences, Abiverdi 1, Chamran Blvd
City
Shiraz
Postal code
Phone
+98 71 3727 1551
Fax
Email
derakhshan@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Derakhshanrad
Position
PhD
Other areas of specialty/work
Street address
School of Rehabilitation-Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
derakhshan@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyed Alireza Derakhshanrad
Position
PhD
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation Sciences, Abiverdi 1, Chamran Blvd
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1551
Fax
+98 71 3627 2495
Email
derakhshan@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)