Determining the effect of task-oriented interventions on motor coordination, balance and school function of children with intellectual disabilities and comparing it with the effect of routine occupational therapy interventions
Design
Clinical trial with control group
Settings and conduct
After selecting the samples among the students with intellectual disabilities, they are randomly divided into two groups of control and intervention. Preliminary assessment of balance, motor coordination, and school function is performed by an evaluator who is blind to groupings. The control group performed routine occupational therapy exercises for 8 weeks, two sessions per week, and the intervention group performed task-oriented exercises in addition to routine occupational therapy exercises. The re-evaluation will then be performed by the same initial evaluator.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Children with intellectual disabilities 5 to 9 years old
IQ 50-70 (teachable group)
Has motor and balance problems
Exclusion criteria:
History of any orthopedic surgery in the last 6 months
History of seizures
Existence of any musculoskeletal problems
Existence of accompanying disabilities
Lack of cooperation of the child
Intervention groups
Task-oriented exercises include:
Walking on the toe in a straight path 4.5 m long and then 4.5 m Walking heel to toe
Jumping forward so that the body is in a balanced position after each jump
Walking a 50-meter path while holding the ball on a screen in balance with one hand
Throwing and receiving the ball with both hands at a distance of two meters
Jumping up and touching at the same time
Main outcome variables
Task-oriented interventions can be used as a simple, low-cost, and accessible method to improve balance and coordination problems and functional performance in children with intellectual disabilities.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200805048311N1
Registration date:2020-08-17, 1399/05/27
Registration timing:prospective
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Seyede zeinab Beheshti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 2028
Email address
z.beheshti@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-01-29, 1399/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of task oriented intervention on motor coordination, balance and school function of children with intellectual disability
Public title
The effect of task oriented intervention on motor coordination, balance and school function of children with intellectual disability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with intellectual disabilities 5 to 9 years old
IQ 50-70 (teachable group)
Has motor and balance problems
Exclusion criteria:
History of any orthopedic surgery in the last 6 months
History of seizures
Existence of any musculoskeletal problems
Existence of accompanying disabilities
Lack of cooperation of the child
Age
From 5 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are selected from students with intellectual disabilities in exceptional schools in Arak who are eligible for inclusion in the study, improbably easy (available sampling) and then placed one by one in the intervention and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
School of Rehabilitation, Golestan Street , Arak
City
Arak
Province
Markazi
Postal code
3818146851
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR.ARAKMU.REC.1399.151
Health conditions studied
1
Description of health condition studied
intellectual disability
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
motor coordination
Timepoint
before intervention and after intervention
Method of measurement
Bruininks Oseretsky Test of Motor Proficiency 2-edition
2
Description
balance
Timepoint
before intervention and after intervention
Method of measurement
Bruininks Oseretsky Test of Motor Proficiency 2-edition
3
Description
school function
Timepoint
before intervention and after intervention
Method of measurement
School Function Assessment scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8 weeks Each week, two sessions of task-oriented interventions include 5 motor activities
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Farjam and Narjesiye spacial school
Full name of responsible person
Seyede Zeinab Beheshti
Street address
School of rehabilitation, Golestan street, Arak
City
arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 2028
Email
z.beheshti@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Deputy of research and technology, Complex of the Great Prophet, University of Medical Science, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seyede Zeinab Beheshti
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Golestan street, Arak
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 2028
Email
z.beheshti@araakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyede Zeinab Beheshti
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Golestan street, Arak
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 2028
Email
beheshti.ot@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyede Zeinab Beheshti
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Golestan street, Arak
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3366 2028
Email
beheshti.ot@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD