The aim of this study was to evaluate the effects of a multimodal exercise program entitled Sports, Play, and Active Recreation for Kids (SPARK) on variables of walking mechanics in boys with autism spectrum disorder (ASD).
Design
A double blind randomized controlled trial
Settings and conduct
Both participants and examiners were unaware of group allocation. During pre and post-tests, children were instructed to walk barefoot along a 15-m walkway. Walking mechanics were measured using foot scan system, motion analysis system, and electromyography system. SPARK was conducted over a period of 8 weeks with three weekly sessions. SPARK included aerobic dance, running games, and jump rope exercises.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the scores of the children with ASD according to the “Gilliam Autism Rating Scale-2” ranged between 62 and 123.
Exclusion criteria: Neuromotor or orthopedic disorders or medication that could affect the central nervous system
Intervention groups
SPARK was conducted over a period of 8 weeks with three weekly sessions. SPARK included aerobic dance, running games, and jump rope exercises.
Effects of an 8 week multimodal exercise program (SPARK) on walking mechanics in boys with autism spectrum disorder
Public title
Effects of an 8 week multimodal exercise program (SPARK) on walking mechanics in boys with autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The scores of the children with autism spectrum disorder according to the “Gilliam Autism Rating Scale-2” ranged between 62 and 123
Age range between 7-12 years old
Exclusion criteria:
Neuromotor or orthopedic disorders or medication that could affect the central nervous system
Age
From 7 years old to 13 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method (block size=4) will be used to allocate study participants into experimental groups. During the randomization procedure, a set of sealed, opaque envelopes will be used to ensure the concealment of the allocation. Each envelope will be contained a card stipulating to which group the participant would be allocated to.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be blinded to group allocation. One examiner will determine whether a participant will eligible for inclusion, while the other will carried out gait analyses of the eligible participants. Both examiners will be unaware of group allocation. Another naïve examiner (i.e., physiotherapist with 10 years professional experience) will be responsible for delivering the treatment to both groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the University of Mohaghegh Ardabili
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Approval date
2021-11-01, 1400/08/10
Ethics committee reference number
IR.UMA.REC.1400.019
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
Platar presuure variables
Timepoint
before and after 8 weeks
Method of measurement
A plantar pressure plate (RsScan International, Belgium, 0.5 m × 0.5× 0.02 m, 4363 sensors)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: SPARK training
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabili city
Full name of responsible person
AmirAli Jafarnezhadgero
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3233 5149
Email
amiralijafarnezhad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Davood Seifzadeh
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3351 0800
Email
seifzadeh@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Mohaghegh Ardabili
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
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 6249
Email
amiralijafarnezhad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 6249
Email
amiralijafarnezhad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
AmirAli Jafarnezhadgero
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
University street
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3353 6249
Email
amiralijafarnezhad@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
Plantar pressure data
When the data will become available and for how long
after publication process
To whom data/document is available
Experts in this field
Under which criteria data/document could be used
Experts in this field
From where data/document is obtainable
by e-mail
What processes are involved for a request to access data/document