The aim of this study is to investigate the effectiveness of hand neoprene splinting on grip, Pinch strength and manual dexterity in children with spastic hemiplegic cerebral palsy. This study is a Quasi -experimental, non- randomized, non- placebo controlled. Twenty children with aged between 6 to 14 years old and diagnosed as a child with spastic hemiplegic by a neurologist, who meet the following inclusion criteria participated in this study. The participants would select randomly from rehabilitation centers in Hamadan city. At the beginning of the study the dynamometer (digital hand dynamometer), digital Pinch gauge will be used in order to measure grip and Pinch strength and the fine motor part of the Bruninks Oseretsky Test of Motor Proficiency Measure which measure the manual dexterity and speed will be used. An independent assessor administers the tests. All children wear a neoprene splint for 6 weeks. After the completion of treatment, the dynamometer, digital Pinch gauge and Bruninks Oseretsky Test of Motor Proficiency Measure would re-administer by the same independence assessor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110915329N1
Registration date:2014-05-16, 1393/02/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Sedigheh sadat Mirbagheri
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 1572
Email address
s.mirbagheri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2014-05-25, 1393/03/04
Expected recruitment end date
2014-06-25, 1393/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hand neoprene splinting on grip, pinch strength and hand manual dexterity, in children with cerebral palsy
Public title
ٍEffect of dynamic splinting on function in children with cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1.Diagnosed with hemiplegia by neurologist 2. Be in levels 2-1 of the manual ability classification system (MACS)
3. Aged from 6 to 14 years.
4. Cooperation of the patient and family Exclusion criteria:
1. Fixed shortness or deformity that limited necessary range of motion for this study.
2. Orthopedic surgery or pharmaceutical interventions in the last 6 months for reducing spasticity
3.Diagnosed with mental retardation or cognitive delays deficits and other impairments ( seizures, visual impairment and etc. )
Age
From 6 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Hamadan University of medical sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide Street, Hamadan
City
Hamadan
Postal code
65178
Approval date
2013-10-29, 1392/08/07
Ethics committee reference number
16/35/9/2403/پ
Health conditions studied
1
Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Grip strength
Timepoint
Before intervention, immediate after intervention, 6 weeks after intervention
Method of measurement
Using Jamar digital hand dynamometer and Kg measure
2
Description
Pinch strength
Timepoint
Before intervention, immediate after intervention, 6 weeks after intervention
Method of measurement
Using Jamar Pinch gauge and Kg measure
3
Description
Manual dexterity
Timepoint
Before intervention, 6 weeks after intervention
Method of measurement
Bruininks-Oseretsky Test of Motor Proficiency, grade scale
Secondary outcomes
1
Description
Height
Timepoint
In first of study
Method of measurement
Meter, centimeter
2
Description
Weight
Timepoint
In first of study
Method of measurement
Weight scale/ Kg
3
Description
Body mass index (BMI)
Timepoint
In first of study
Method of measurement
Weight/(height)^2
Intervention groups
1
Description
Wearing neoprene splint in intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Sedigheh Sadat Mirbagheri
Street address
Department of Occupational therapy, Farshchian Hospital, Mirzade Eshghi Street, Hamadan
City
Hamadan
2
Recruitment center
Name of recruitment center
Sheikhoraeis center of therapeutic educational
Full name of responsible person
Sedigheh Sadat Mirbagheri
Street address
Sheikhoraeis center of Therapeutic educational, Khaje Rashid Street, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Vice chancellor for research, University of Medical Sciences, Shahid Fahmide street, Hamadan.
City
Hamadan
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, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Soraya Gharbaghi
Position
Faculty of rehabilitation /MSc of occupation therapy.
Other areas of specialty/work
Street address
Occupational therapy department, faculty of rehabilitation, Hamadan university of Medical Sciences, Hamadan.
City
Hamadan
Postal code
Phone
+98 81 1838 1572
Fax
Email
gharebaghy_ot@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rehabilitation faculty, Hamadan university of Medical Sciences
Full name of responsible person
Sedigheh Sadat Mirbagheri
Position
MSc of Orthoses and Prosthetics
Other areas of specialty/work
Street address
Occupational therapy department, Rehabilitation Faculty, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 1572
Fax
Email
smirbagheri110@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences.
Full name of responsible person
Sedigheh Sadat Mirbagheri
Position
faculty/ MSC
Other areas of specialty/work
Street address
Department of Occupational therapy, Rehabilitation Faculty, Hamadan University of Medical Sciences, Shahid Fahmide St., Hamadan
City
Hamadan
Postal code
Phone
+98 81 1838 1571
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)