Effect of occupational therapy home program versus no therapy on gross and fine motor development in children with cerebral palsy: a single blind randomized clinical trial
Objectives: To assess the effect of occupational therapy home program versus no therapy on gross and fine motor development in children with cerebral palsy.
Design: a single blind randomized clinical trial.
Setting and conduct: The eligible children with cerebral palsy who will refer to the treatment centers of University of Social Welfare and Rehabilitation Sciences during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 5 to 10 years; (b) affected with cerebral palsy; (c) score of 3 to 5 based on GMFCS system; (d) mother of child had at least ability to read and write; (e) the mother does not care another disable child simultaneously.
Exclusion criteria: (a) the child undergoes surgery or receiving Botox during study period; (b) having multiple disability such as blindness, deafness, congenital hip dislocation, and drug resistance seizure.
Intervention group: a two hour educational session for caregivers who will care the children cerebral pals plus receiving routine care.
Control group: only receiving routine care.
Primary outcome: (a) assessing fine motor development before and 3 months after intervention using Bruininks-Oseretsky Test; (b) assessing gross motor development before and 3 months after intervention using Gross Motor Function Measure (GMFM).
Secondary outcome: nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507139014N71
Registration date:2015-08-06, 1394/05/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of occupational therapy home program versus no therapy on gross and fine motor development in children with cerebral palsy: a single blind randomized clinical trial
Public title
Effect of occupational therapy home program versus no therapy on gross and fine motor development in children with cerebral palsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 5 to 10 years; (b) affected with cerebral palsy; (c) score of 3 to 5 based on GMFCS system; (d) mother of child had at least ability to read and write; (e) the mother does not care another disable child simultaneously.
Exclusion criteria: (a) the child undergoes surgery or receiving Botox during study period; (b) having multiple disability such as blindness, deafness, congenital hip dislocation, and drug resistance seizure.
Age
From 5 years old to 10 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The children will be randomly assigned to intervention and control groups through drawing of lots.
Blinding: The patients will be aware of the type of intervention. However, the examiner who will examine the patients will be someone else who will not be aware of the intervention. Therefore, the trial will be run as single blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tehran University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Tehran University of Medical Sciences, Enghelab Ave
City
Tehran
Postal code
Approval date
2012-07-26, 1391/05/05
Ethics committee reference number
91/801/9/1/7389
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
assessing fine motor development
Timepoint
before and 3 months after intervention
Method of measurement
using Bruininks-Oseretsky Test
2
Description
assessing gross motor development
Timepoint
before and 3 months after intervention
Method of measurement
using Gross Motor Function Measure (GMFM)
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
a two hour educational session for caregivers who will care the children cerebral pals plus receiving routine care
Category
Treatment - Other
2
Description
only receiving routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Johari
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Alley, Daneshjoo Bulvar, Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Tehran University of Medical Sciences
Full name of responsible person
Dr Albar Fotouhi
Street address
Tehran University of Medical Sciences, Enghelab Ave
City
Tehran
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 the Technology, Tehran 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Johari
Position
Rehabilitation Student
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Alley, Daneshjoo Bulvar, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0086
Fax
Email
saharjohari85@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Johari
Position
Rehabilitation Student
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Alley, Daneshjoo Bulvar, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0086
Fax
Email
saharjohari85@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Sahar Johari
Position
Rehabilitation Student
Other areas of specialty/work
Street address
University of Social Welfare and Rehabilitation Sciences, Koodakyar Alley, Daneshjoo Bulvar, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0086
Fax
Email
saharjohari85@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)