To study the effects of dual-task exercises and single-task exercises on functional balance in children with autism spectrum disorder
Design
This will be a single blind clinical trial witch contains two group of single-task and dual-task. The simple method (Non blocked) will be used as randomization method and the sealed envelope method will be used. By means of a specific formula, sample size was determined 20 person for each group.
Settings and conduct
Interventions will take place in Iran Autism Association and autism schools in Tehran. They will last for 12 session, 3 days a week and maximum 45 minutes each session.Participants in single_task group will perform only balance exercises and participants in dual-task group will do the same balance exercises concurrent with cognitive exercises. Cognitive tasks will be choosen in the beginning of each session accidental by the participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Children diagnosed with Autism spectrum disorder aged 9 to 14,
Educable children (IQ above 50),
Exclusion criteria:
Being able to stand on one foot for 30 seconds,
Having the history of seizure, epilepsy, neurological disorders, orthopedic disorders,
Using drugs which affects in balance.
Intervention groups
In this research participants will divide into single-task and dual-task groups. Participants in single-task group will only perform the balance exercises and the participants in dual-task group will perform balance exercises and cognitive exercises concurrently. The cognitive tasks for each session, will be chosen by the participant at the beginning of the session.
Main outcome variables
Berg balance scale and Mini-BESTEST will be done to study functional balance. Timed up and go test will be done to study dynamic balance. Because Gait speed test were used to determine sample size, this test will be done in dual-task and single-task.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181014041341N1
Registration date:2019-02-09, 1397/11/20
Registration timing:registered_while_recruiting
Last update:2019-02-09, 1397/11/20
Update count:0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Maryam Yaghoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 8798
Email address
m-yaghoubi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Dual-task and Single-task Exercises on Functional Balance in Children with Autism Spectrum Disorder
Public title
The Effects of Dual-task and Single-task Exercises on Functional Balance in Children with Autism Spectrum Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with autism spectrum disorder 9 to 14 years old
Educable children (IQ above 50)
Exclusion criteria:
Being able to stand on one leg for 30 seconds
Having a history of seizure, epilepsy, neurological disease, orthopedic disease
Using medicines that have side effects on balance
Age
From 9 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple method (non blocked) will be used as randomization method and the sealed envelope method will be used. The number will be selected in Excel randomly and will be written on papers and the papers will be inserted in the envelopes and the envelopes will be sealed. A person who is not take part in the trial will select the numbers. The even numbers indicate the sample will be in Single-task group and the odd numbers indicate the sample will be in Dual-task group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the participants will be unaware of the group witch they have been allocated in.The final assessments will be done by an assessor who does not know about the group of the samples.
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 School of Rehabilitation, Pich-e-Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
۱۱۴۸۹۵۶۱۱۱
Approval date
2018-08-29, 1397/06/07
Ethics committee reference number
IR.TUMS.FNM.REC.1397.086
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders
ICD-10 code
F84.0
ICD-10 code description
Childhood Autism
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dynamic Balance
Timepoint
Before the onset of interventions, After 6th session of intervention, After the termination of interventions
Method of measurement
Gait Speed Test (Dual-task and Single-task)
Secondary outcomes
1
Description
Functional Balance
Timepoint
Before the onset of interventions, After 6th session of interventions, After the termination of interventions
Method of measurement
Pediatric Berg Balance Scale; Mini-BESTEST; Timed Up and Go test
Intervention groups
1
Description
Intervention group No1: Participants in this group will perform single-task exercises based on Silsupadol's protocol (2009). Balance exercises in this group is just like balance exercises in Dual-task group. The exercises will perform in 12 sessions, maximum 45 minutes, for 3 days a week for 4 weeks.
Category
Rehabilitation
2
Description
Intervention group No2: Participants in this group will perform dual-task exercises based on Silsupadol's protocol (2009). This group will perform balance exercises and cognitive exercises (counting/ reverse counting/ auditory memory/ mention fruits, animals, foods, seasons, months, week days/ objects application, Raven test) concurrently. The exercises will perform in 12 sessions, maximum 45 minutes, for 3 days a week for 4 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Autism Association
Full name of responsible person
Saede Ghafari
Street address
No 8. Lale Blvd. After Hemmat Bridge. South Sattari Autobahn
City
Tehran
Province
Tehran
Postal code
۱۱۴۸۹۶۱۱۱
Phone
+98 21 4442 2525
Email
ERR@irautism.org
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Pasalar
Street address
No 56, Corner of Italia Street, Vesal-e-shirazi Street, keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417755331
Phone
+98 21 8898 9161
Email
ssrc@tums.ac.ir
Grant name
Grant code / Reference number
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
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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Yaghoubi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Pich-e-shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
m-yaghoubi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Parvin Raji
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Pich-e-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 8798
Email
parvin.raji@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Yaghoubi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Pich-e-Shemiran, Enghelab Street
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
m.yaghoubi1994@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to main end will be published
When the data will become available and for how long
Data will be accessible after the essay publication
To whom data/document is available
Investigators who work in university and academic institutions
Under which criteria data/document could be used
Investigators who are occupational therapist and other fields witch are related to children with autism spectrum disorder
From where data/document is obtainable
Maryam Yaghoubi
m.yaghoubi1994@gmail.com
m-yaghoubi@razi.tums.ac.ir
Dr. Parvi Raji
parvin.raji@gmail.com
What processes are involved for a request to access data/document
Applicant can connect researchers by means of Email, after studying the data witch are needed, they will be accessible in one week.