Objectives: The purpose of this study is to evaluate sensory based interventions on hand function of children with Autism Spectrum Disorders. Design: Participants are selected from children with Autism, aged 4-14 years old, in Occupational Therapy Clinics in Tehran. 50 children are randomly assigned into control or intervention group by coded envelop. Setting and conduct: Evaluations are done two times before intervention and immediately after the end of intervention by a trained Occupational Therapist who is blind to type of group. Participants: children should get a Wechsler IQ score of 90. Intervention: After the baseline assessments, treatment sessions are given, 2 sessions per week, each session about 30-45 minutes for 8 weeks. Each session of treatment includes: A: Modulation of sensory defensiveness (in touch, vestibular, and proprioception) such as active movements on scooter board, Wilbarger protocol, deep touch pressure. B: Improvement of hypo responsivity such as fast brushing, up and down jumping on trampoline. Main outcome measures: Bruininks-Oseretsky Test of Motor Proficiency and Vineland Adaptive Behavior Scales
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710083551N8
Registration date:2017-10-18, 1396/07/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-18, 1396/07/26
Registrant information
Name
Parvin Raji
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
praji@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for education,Tehran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sensory based interventions on hand function of children with Autism Spectrum Disorders
Public title
The effect of sensory based interventions on hand function of children with Autism Spectrum Disorders
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Children aged 14-4 years old with diagnosis of autism; Get a score of 90 from the Wechsler intelligence test; Earn score 38-141 of the Short Sensory Profile (SSP) Questionnaire, which means that they have difficulty in sensory processing. Exclusion criteria: No taking anti-seizure medication during the last six months; No intention to continue cooperation in research.
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St, Ghods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2017-09-27, 1396/07/05
Ethics committee reference number
IR.TUMS.FNM.REC.1396.3592
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
Motor Proficiency
Timepoint
before intervention, immediately after the end of intervention
Method of measurement
Bruininks-Oseretsky Test of Motor Proficiency
Secondary outcomes
1
Description
Adaptive behavior
Timepoint
before intervention, immediately after the end of intervention
Method of measurement
Vineland Adaptive Behavior Scales
Intervention groups
1
Description
Control group: Sensory Integration intervention
Category
Rehabilitation
2
Description
Intervention group: Sensory Integration intervention+ Modulation of sensory defensiveness (in touch, vestibular, and proprioception) such as active movements on scooter board, Wilbarger protocol, deep touch pressure and Improvement of hypo responsivity such as fast brushing, up and down jumping on trampoline.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Occupational Therapy Clinics in Tehran
Full name of responsible person
Safoora Azizi
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for education,Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Jalili
Street address
Vice chancellor for education,7th floor,Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran
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 education,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
Full name of responsible person
Parvin Raji
Position
Assiatant Professor
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 7753 8798
Fax
Email
praji@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Assisted Professor
Other areas of specialty/work
Street address
Rehabilitation faculty of Tehran University of Medical Sciences, Picheshemiran, Enghelab Ave, Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 7753 8798
Fax
Email
praji@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Assisted Professor
Other areas of specialty/work
Street address
Rehabilitation faculty, picheshemiran, Enghelab Ave, Tehran
City
Tehran
Postal code
Phone
+98 21 7753 8798
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)