Protocol summary

Study aim
This study aims to investigate the effect of perceptual motor Exercises along with music and Vitamin D3 Supplementation on Nerve Growth Factor (NGF), Attention, motor proficiency and GARS-2 in 6 to 9 years old children suffering from autism disorder.
Design
Among children with autism in autistic children care centers in Isfahan, 150 children were selected using screening tests. The children with autism spectrum disorders were randomly selected from the Autism Center. Then, They were randomly assigned to one of the four study groups and receive the special intervention. They were randomly divided into Four groups: group 1= perceptual-motor Exercises along with music; Group 2= Vitamin D3 supplementation; Group 3= perceptual-motor Exercises along with music and Vitamin D3; and Group 4= Placebo.
Settings and conduct
Participants were screened by an experienced physician and were found eligible to participate in Perceptual-motor Exercises and Vitamin D Supplementation. Participants of the group 1 received perceptual-motor exercises along with music instruction 1 session/day, 3 days/week for 12 weeks. The sessions were carried out in a therapy room located at the Center of Autism. The intervention related to the group 2 includes intake of Vitamin D tablets (300 IU/ day not to exceed 5,000 IU/day). In Group 3, both interventions of Groups 1 and 2 were conducted for 3 months (Perceptual-motor Exercises along with music was 36 sessions (3 months) + receive vitamin D3 drops, 300 IU/ day not to exceed 5,000 IU/day for 3 months.). Children with ASD in Group 4 also received placebos during the investigation period. The placebo consisted of a combination of polysorbate 20, which is the same fragrance ingredient used in vitamin D drops in addition to glycerin, disodium edetate, and b-cyclodextrin in purified water. Finally, all subjects were subjected to post-test using the research kit of the NGF, stroop test, Bruininks-Oseretsky Test of Motor Proficiency, GARS-2.
Participants/Inclusion and exclusion criteria
Inclusion criteria: an autism diagnosis confirmed by a psychologist along with a medical team and based on diagnostic criteria DSM-5; Children with high-functioning autism disorder; obtaining consent from parents; Vitamin D serum level less than 30 ng/ml. Exclusion criteria: Subjects who had associated gastrointestinal problems; neurological diseases and children with malnutrition.
Intervention groups
Intervention group 1: The protocol of Perceptual-motor Exercises along with music was 36 sessions at 12 weeks (3 months) and three sessions per week, with each session lasting 60 minutes. They included stretching and jogging (10 minutes), main perceptual-motor exercises (45 minutes), and cool down (5 minutes). Intervention group 2: The intervention related to the group 2 includes intake of Vitamin D tablets (300 IU/ day not to exceed 5,000 IU/day). Intervention group 3: In Group 3, both interventions of Groups 1 and 2 were conducted for 3 months (Perceptual-motor Exercises along with music was 36 sessions (3 months) + receive vitamin D3 drops, 300 IU/ day not to exceed 5,000 IU/day for 3 months). Control group: Children with ASD in Group 4 also received placebos during the investigation period. The placebo consisted of a combination of polysorbate 20, which is the same fragrance ingredient used in vitamin D drops in addition to glycerin, disodium edetate, and b-cyclodextrin in purified water.
Main outcome variables
Nerve Growth Factor Attention Motor Proficiency Stereotypic Behaviors Communication Social

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150519022323N2
Registration date: 2017-12-16, 1396/09/25
Registration timing: retrospective

Last update: 2017-12-16, 1396/09/25
Update count: 0
Registration date
2017-12-16, 1396/09/25
Registrant information
Name
Hadi Moradi
Name of organization / entity
Ferdowsi University Of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 38 3422 8893
Email address
hadi.moradi@stu.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
2016-11-20, 1395/08/30
Actual recruitment end date
2017-03-19, 1395/12/29
Trial completion date
empty
Scientific title
The effect of Perceptual-motor Exercises along with music and Vitamin D3 Supplementation on Nerve Growth Factor, Attention, motor proficiency and GARS-2 in children with high-functioning autism
Public title
The effect of Perceptual motor Exercises along with music and Vitamin D3 Supplementation in children with autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
An autism diagnosis confirmed by a psychologist along with a medical team and based on diagnostic criteria DSM-5 Children with high-functioning autism disorder Vitamin D serum level less than 30 ng/ml Chronological age between six and nine years IQ more than 70 Sound sense of sight and hearing Obtaining consent from parents
Exclusion criteria:
Children with autoimmune disorders Subjects who had associated gastrointestinal problems Children with neurological diseases Children with malnutrition Children with anemia Children with orthopedic and respiratory disorders Seizure attacks in the last two years
Age
From 6 years old to 9 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
The children with autism spectrum disorders were randomly selected from the Autism Center. Then, They were randomly assigned to one of the four study groups and receive the special intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University Of Medical Sciences, Azadi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.MUMS.REC.1396.129

Health conditions studied

1

Description of health condition studied
autism
ICD-10 code
F84.0
ICD-10 code description
Childhood autism

Primary outcomes

1

Description
Nerve Growth Factor
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
The research kit of the Nerve Growth Factor

2

Description
Attention
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
Stroop test

3

Description
Motor proficiency
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
Bruininks-Oseretsky Test of Motor Proficiency

4

Description
Stereotypic behaviors
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
Gilliam Autism Rating Scale-Second Edition (GARS-2)

5

Description
Communication
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
Gilliam Autism Rating Scale-Second Edition (GARS-2)

6

Description
Social
Timepoint
Before Intervention, 12 Weeks After Intervention
Method of measurement
Gilliam Autism Rating Scale-Second Edition (GARS-2)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: The protocol of Perceptual-motor Exercises along with music was 36 sessions at 12 weeks (3 months) and three sessions per week, with each session lasting 60 minutes. They included stretching and jogging (10 minutes), main perceptual-motor exercises (45 minutes), and cool down (5 minutes).
Category
Rehabilitation

2

Description
Intervention group 2: The intervention related to the group 2 includes intake of Vitamin D tablets (300 IU/ day not to exceed 5,000 IU/day).
Category
Treatment - Drugs

3

Description
Intervention group 3: In Group 3, both interventions of Groups 1 and 2 were conducted for 3 months (Perceptual-motor Exercises along with music was 36 sessions (3 months) + receive vitamin D3 drops, 300 IU/ day not to exceed 5,000 IU/day for 3 months).
Category
Treatment - Other

4

Description
Control group: Children with ASD in Group 4 also received placebos during the investigation period. The placebo consisted of a combination of polysorbate 20, which is the same fragrance ingredient used in vitamin D drops in addition to glycerin, disodium edetate, and b-cyclodextrin in purified water.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Autism Center
Full name of responsible person
Mojtaba Gashool
Street address
Jomhouri-e-Eslami Square
City
Esfahan
Province
Isfehan
Postal code
8871796545
Phone
+98 31 3422 8893
Email
Hadimoradi_85@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ferdowsi University Of Mashhad, Mashhad
Full name of responsible person
Mehdi Sohrabi
Street address
Ferdowsi University Of Mashhad, Paradise Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48979
Phone
+98 51 3882 9580
Fax
+98 51 3882 9580
Email
sohrabi@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University Of Mashhad, Mashhad
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ferdowsi University Of Mashhad
Full name of responsible person
Hadi Moradi
Position
Ph.D Student Of Motor Development
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ferdowsi University Of Mashhad, Azadi
City
Mashhad
Province
Razavi Khorasan
Postal code
88717-96545
Phone
+98 38 3422 8893
Fax
Email
hadi.moradi@stu.um.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University Of Mashhad
Full name of responsible person
Hadi Moradi
Position
Ph.D Student Of Motor Development
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ferdowsi University Of Mashhad, Azadi
City
Mashhad
Province
Razavi Khorasan
Postal code
8871796545
Phone
+98 38 3422 8893
Fax
Email
hadi.moradi@stu.um.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University Of Mashhad
Full name of responsible person
Hadi Moradi
Position
Ph.D Student Of Motor Development
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Ferdowsi University Of Mashhad, Azadi
City
Mashhad
Province
Razavi Khorasan
Postal code
8871796545
Phone
+98 38 3422 8893
Fax
Email
hadimoradi_85@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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