This study is a before-after clinical trial on 13 children (8 boys and 5 girls) with cerebral palsy. Children are entered into this study from special schools in Tehran. After signing the consent from parents, The participants will be recruited in this study and completed a demographic questionnaire; initial assessment includes passive range of wrist extension, palmar and radial abduction of the thumb using a goniometer, hand function in patients with box & block test that is performed by the experimenter and relevant information is recorded (the order of tests is randomly). The code is given to all patients and the assessments are performed by another examiner. After the initial assessment, patients are referred for splint construction. The splint is placed in the dominant hand thumb web space (between index finger metacarpo phalangeal and thumb inter phalangeal ). Duration of splinting is 4 to 6 hours per day (outside of school hours) and 6 to 8 hours at night and for 8 weeks. Parents are recorded time use of splint in schedule every day. The parents are taught the proper use of splints, maintenance procedures and its health. After 8 weeks of splinting, the initial assessment is performed by the experimenter and results are analyzed. In the intervening period, patients receive a similar occupational therapy programs.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012070310179N1
Registration date:2012-07-18, 1391/04/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-18, 1391/04/28
Registrant information
Name
Nafiseh sadat Sharifi
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 25 1292 9573
Email address
sharifi_n@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research of Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of short thumb splint on hand function in cerebral palsy children
Public title
The effect of short thumb splint on hand function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.8-12 years old cerebral palsy children, diagnosed according to the neurologist.
2.Border and a higher IQ (according to school records).
3.Lack of surgery experience in upper extremity, according to records or the parents
4.If there are seizures can be controlled.
5.There is at least 40 degree abduction in thumb.
6.There is up to 3 scale of modified ashworth in the dominant thumb and wrist.
7.Lack of usage of other upper limb splints at the time of the implementation.
8.Lack of usage of medication to reduce spasticity in time of the implementation.
Exclusion criteria:
1.Lack of cooperation of parents and children.
2.Orthopedic injuries occurring during the intervening time.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research of tehran uinversity of medical science
Street address
Enghelab street -ghods street-por sina street-tehran school of medical science-school medicine-third floor-technology research center
City
Tehran
Postal code
Approval date
2012-06-28, 1391/04/08
Ethics committee reference number
91-02-61-16980-58485
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Hand function
Timepoint
before the intervention, after 2 month
Method of measurement
box & block test
Secondary outcomes
1
Description
Wrist and thumb range of motion
Timepoint
Before the intervention, after 2 month
Method of measurement
Goniameter
Intervention groups
1
Description
Use of short thumb splint for 8 weeks( 6-8 hours per day and 4-6 hours per night)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tavan khahan special school
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Emam ali special school
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Haji babaiy special school
Full name of responsible person
Street address
City
Tehran
4
Recruitment center
Name of recruitment center
Kosha special school
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research of tehran university of medical science
Full name of responsible person
Dr fotohi
Street address
Enghelab street-ghods street-por sina street-school of tehran medical science- school of medicine-third floor-research center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research of tehran 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
Theran university of medical science
Full name of responsible person
Nafiseh sadat Sharifi
Position
student of MSc
Other areas of specialty/work
Street address
Tehran-enghelab-amir abad-medical science kooy
City
Tehran
Postal code
Phone
+218 4743039
Fax
Email
n.sh5711@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran uinversity of medical science
Full name of responsible person
Nafiseh sadat Sharifi
Position
Student of MSc
Other areas of specialty/work
Street address
Tehran-enghelab-amir abad-medical science kooy
City
Tehran
Postal code
Phone
+98 21 8474 3039
Fax
Email
n.sh5711@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran uinversity of medica science
Full name of responsible person
Nafise sadat Sharifi
Position
Student of medical science
Other areas of specialty/work
Street address
enghelab-amir abad-medical science kooy
City
Tehran
Postal code
Phone
00
Fax
Email
n.sh5711@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)