The purpose of this interventional non-randomized, pretest-posttest trial is to investigate the efficacy of using ball playing in movement skills and coping behaviors in 20 children with autism spectrum disorders aged between 5 and 7, who are involved in no co-morbidity or secondary disorders. At first, Vaynlnd Adaptive behavior scale and Peabody Developmental Motor Scales are performed as pretests, then interventional phase are started and children receive ball playing skills for 5 weeks; finally Vaynlnd Adaptive behavior scale and Peabody Developmental Motor Scales are performed again as posttests and the differences between pretests-posttests scores are compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109037462N1
Registration date:2011-10-08, 1390/07/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-08, 1390/07/16
Registrant information
Name
Mohammad Reza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
pprc@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-11-21, 1390/08/30
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of using ball playing in movement skills and coping behaviors in children with autism
Public title
Efficacy of using ball playing in movement skills and coping behaviors in children with autism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 5-7 years old, Autism Spectrum Disorder diagnosis by child and adolescent psychiatrist according to DSM-IV
Exclusion criteria: epilepsy, cerebral palsy, brain damage, metabolism disorders and other secondary disorders
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
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
Tehran University of Medical Sciences
Street address
Qods street, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2011-09-10, 1390/06/19
Ethics committee reference number
1172,130,ص,90
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Childhood autism
Primary outcomes
1
Description
Socialization
Timepoint
Baseline, 5 weeks after intervention
Method of measurement
Vaynlnd Adaptive behavior scale
2
Description
communication
Timepoint
Baseline, 5 weeks after intervention
Method of measurement
Vaynlnd Adaptive behavior scale
3
Description
activities of daily living
Timepoint
Baseline, 5 weeks after intervention
Method of measurement
Vaynlnd Adaptive behavior scale
Secondary outcomes
1
Description
Gross Motor skills
Timepoint
Baseline, 5 weeks after intervention
Method of measurement
Peabody Developmental Motor Scales, Second Edition: PDMS-2
2
Description
fine Motor skills
Timepoint
Baseline, 5 weeks after intervention
Method of measurement
Peabody Developmental Motor Scales, Second Edition: PDMS-2
Intervention groups
1
Description
firstly, current treatments, without performing interventional phase are administered during 5 weeks. in this stage current treatments such as Speech Therapy, occupational therapy, Lovaas approach are performed, then Peabody,Vineland and questionnaire for evaluation of treatment of autism as pretests are administered.
Category
Treatment - Other
2
Description
using ball playing are performed for 5 weeks. in this interventional stage, children pass 10 therapeutic sessions 2 times per week during 5 weeks. 4 types of ball with different features are used and different ball playing skills such as: catching, throwing, striking by hands and feet or striking by device to ball are administered per session. practices are arranged from easy to hard and firstly, therapist interprets the performing format of practice viva voce and then performs it practically. after that, she helps children to perform Movement patterns correctly until they will be able to perform practices independently. practice performing with at least one of the essential balls is the basis of ball playing skills instruction; when children can perform the practice with one ball, other essential balls will be used to increase skills in that practice. at the end of fifth week, Peabody, Vineland tests and questionnaire for evaluation of treatment of autism as posttests are administered.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry and Psychology Research Center, Roozbeh Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnoosh Golband
Street address
Qods street, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
11572
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences, Psychiatry research center
Full name of responsible person
Mohammad Reza Mohammadi
Position
MD/Head of Psychiatry research center
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mohammadimr@tums.ac.ir
Web page address
www.pprc.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatry and Psychology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammadi
Position
MD
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, after the Lashkar crossroads, Tehran, IRAN.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
mohammadimr@tums.ac.ir
Web page address
www.pprc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Psychiatry and Psychology Research Center
Full name of responsible person
Maryam Salmanian
Position
MS/Researcher
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 5541 3540
Fax
Email
marysal1981@gmail.com
Web page address
www.pprc.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)