Determining the effect of eight weeks hydrotherapy on the serotonin and Brain-derived neurotrophic factor (BDNF) level in children with Autism.
Design
These clinical trial includes training and control group that has been randomly divided into two groups. The sample size is 32 and participants are the children with autism in Kahrizak charity.
Settings and conduct
Research in Kahrizak Charity Organization has been done after getting parents and children written consent. Then, a pre-test has been performed , after 2 months of hydrotherapy, a post-test has been performed. blinding has been done for testers, including psychologists and lab technician.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of autism, 6 to 14 years old, male gender, tolerance to motion, lack of motor problem.
Non-inclusion criteria: Having other diseases , Skin problems
Intervention groups
The subjects of the present study has been randomly divided into 2 groups , including training groups (n=16) and control group (n=16). The training group has carried out three sessions of eight weeks (two months) and a 60-minutes Halliwick program. The control group has also conducted their routine activities during the study.
Main outcome variables
Main source variables included : Serotonin and Brain-derived neurotrophic factor Serum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180416039330N1
Registration date:2018-11-22, 1397/09/01
Registration timing:retrospective
Last update:2018-11-22, 1397/09/01
Update count:0
Registration date
2018-11-22, 1397/09/01
Registrant information
Name
hadi farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3342 2153
Email address
hadifarahani@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-02, 1396/10/12
Expected recruitment end date
2018-03-14, 1396/12/23
Actual recruitment start date
2018-01-02, 1396/10/12
Actual recruitment end date
2018-03-14, 1396/12/23
Trial completion date
empty
Scientific title
Effect of hydrotherapy on serum serotonin and BDNF in children with Autism spectrum disorders
Public title
Effect of hydrotherapy on serotonin and BDNF in children with Autism spectrum disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Autism Spectrum Disorders
Age of 6 to 14 years
Male gender
Exercise Tolerance
Exclusion criteria:
Movement problem
Having other diseases
Skin problems
Age
From 6 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
32
Actual sample size reached:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals in the groups have been matched based on autism severity , then randomly divided to two groups (experimental and control) by research randomizer software.
Blinding (investigator's opinion)
Double blinded
Blinding description
For assesment of autism severity two psychologists and for blood test a laboratory expert have been acquired. 2 psychologists and a laboratory technician evaluated all participants without knowing the grouping and by number encoding at the beginning and at the end of the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2017-09-19, 1396/06/28
Ethics committee reference number
IR.IAU.RASHT.REC.1395.104
Health conditions studied
1
Description of health condition studied
Autism
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum Serotonin
Timepoint
Serotonin measurements before and after 2 months of hydrotherapy
Method of measurement
Elisa kit (zellbio) Germany
2
Description
Serum Brain-derived neurotrophic factor
Timepoint
Brain-derived neurotrophic factor measurements before and after 2 months of hydrotherapy
Method of measurement
Elisa kit (zellbio) Germany
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 24 sessions of hydrotherapy in 2 months. 3 sessions per week for 60 minutes and the Halliwick method is used for this study.
Category
Rehabilitation
2
Description
Control group: This group did not do any additional activity during the 2 months of the study.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Charity Foundation
Full name of responsible person
Dr. Afshin Vejdani
Street address
Esfahaniha Street, Golestanak Road, Mohammad Shahr
City
Karaj
Province
Alborz
Postal code
31845167
Phone
+98 26 3630 9171
Fax
+98 26 3630 1859
Email
Kahraj@kahrizak.com
Web page address
http://kahrizak.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Alireza Elmiye
Street address
Islamic Azad University Rasht Branch
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3342 2153
Email
info@iaurasht.ac.ir
Web page address
http://iaurasht.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Hadi Farahani
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University Rasht Branch
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13334231534
Email
hadifarahani111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadi Farahani
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University Rasht Branch
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13334231534
Email
hadifarahani111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadi Farahani
Position
Teacher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University Rasht Branch
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 3153
Email
hadifarahani111@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data includes the main consequence of the unidentifiable sharing of people.
When the data will become available and for how long
The beginning of the access period is one year after the publication of the results.
To whom data/document is available
The data can only be sent to researchers.
Under which criteria data/document could be used
Terms include academic emails as well as academic specifications and the reason for requesting data.