Protocol summary

Study aim
An investigation of rhythm and body percussion effects on motor and social skills of 8-12 years old children with intellectual disability
Design
َA randomized clinical trial with a control group, parallel group
Settings and conduct
Two schools will be selected non randomly and then the Bruininks-Oseretsky test will be taken from the 60 students who have inclusion criteria and a letter of consent. The tests will be conducted by a blinded/trained evaluator and the Matson Evaluation of Social Skills with Youngsters-II will be completed by the teachers. The students will be randomly assigned to experimental and control groups. The control group will not receive any intervention. The experimental group will receive body percussion exercises for 3 mounts in a group format.
Participants/Inclusion and exclusion criteria
• Detection of mild intellectual disability by the measurement of Khorasan Razavi Exceptional Education department • Being in the age group of 8-12 years • No neurological disorders • No psychiatric disorders such as ADHD and Autism • No orthopedic disorders that cause problems on baby's movements. • No vision and hearing impairment that disrupts understanding of orders.
Intervention groups
The experimental group will receive rhythmic body percussion exercises in a group format. The exercises include: clapping, hitting hands on the chest, hitting hands on the leg, hitting feet on the floor and hitting hand of the opponent. The exercises are researcher made, from simple to complex and based on team experience and resources review. They will be selected under the guidance of rhythmic instrument experts. The exercises will take place 3 months, 24 sessions and 2 days per week for 30 minutes per session. The control group will not receive any body percussion exercises.
Main outcome variables
Change in motor skills (gross, fine, Upper limb coordination skills); Change in social skills.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190518043624N1
Registration date: 2019-08-01, 1398/05/10
Registration timing: retrospective

Last update: 2019-08-01, 1398/05/10
Update count: 0
Registration date
2019-08-01, 1398/05/10
Registrant information
Name
Salehe Lotfi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
lotfi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-05-22, 1398/03/01
Scientific title
An investigation of rhythm and body percussion effects on motor and social skills of 8-12 years old children with intellectual disability
Public title
The effect of rhythm and body percussion on motor and social skills of children with intellectual disability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of mild intellectual disability by the measurement of Khorasan Razavi Exceptional Education department Being in the age group of 8-12 years
Exclusion criteria:
Neurological disorders such as cerebral palsy, epilepsy and seizure (based on medical records or doctor's diagnosis) Psychiatric disorders such as ADHD and Autism Orthopedic disorders that cause problems on baby's movements. Vision and hearing impairment that disrupts understanding of orders.
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 57
Randomization (investigator's opinion)
Randomized
Randomization description
At first, two schools will be selected non randomly, and 60 students will be chosen based on inclusion criteria and after taking satisfaction they will be assigned into the two groups of experimental and control by using simple randomization methods. Card or envelopes shuffling will be used for simple randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Crossroads of Shahid Hemmat and Shahid Chamran Expressways, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-03-06, 1397/12/15
Ethics committee reference number
IR.IUMS.REC.1397.1132

Health conditions studied

1

Description of health condition studied
Mild mental retardation
ICD-10 code
F70
ICD-10 code description
Mild mental retardation

Primary outcomes

1

Description
Change in motor skills (gross, fine and Upper limb coordination motor skills)
Timepoint
At the beginning of the study and 1 week after the end of the intervention
Method of measurement
1-The Bruininks-Oseretsky test of motor proficiency

2

Description
Change in social skills
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
The Matson Evaluation of Social Skills with Youngsters-II (MESSY-II )

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group will receive body percussion exercises in a group format. The percussion exercises include: clapping, hitting hands on the chest, hitting hands on the leg, hitting feet on the floor and hitting hand of the opponent. The exercises are researcher made type, from simple to complex and based on team experience and resources review. These exercises will be selected under the guidance of rhythmic instrument experts. The exercises will take place 3 months, 24 sessions and 2 days per week with the time of 30 minutes per session. At first, the exercises will be done individually in order to the candidate learn rhythmic percussion and then the number of participants in the group will be increased gradually.
Category
Other

2

Description
Control group: will receive school routine instruction without any body percussion exercises
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of exceptional Education Khorasan Razavi
Full name of responsible person
Mahin Tavakoli
Street address
Akhound Khorasani 20,Akhound Khorasani Ave, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9133714165
Phone
+98 51 3225 4060
Email
salehe.lotfi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research
Street address
Crossroads of Shahid Hemmat and Shahid Chamran Expressways, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 7774 5945
Email
salehe.lotfi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Salehe lotfi
Position
Master srudent
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Nezam Alley, Shah Nazari Ave., Mohseni Square, Tehran
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
salehe.lotfi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Salehe Lotfi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Nezam Alley, Shah Nazari Ave., Mohseni Square, Tehran
City
Tehran
Province
Tehran
Postal code
154913487
Phone
+98 21 2222 2059
Fax
Email
salehe.lotfi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Salehe Lotfi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Nezam Alley, Shah Nazari Ave., Mohseni Square, Tehran
City
Tehran
Province
Tehran
Postal code
154913487
Phone
+98 21 2222 2059
Fax
Email
salehe.lotfi@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data that related to primary outcome are available.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
This is only available for people working in academic institutions or people working in rehabilitation clinics.
Under which criteria data/document could be used
No analyzes are allowed
From where data/document is obtainable
salehe.lotfi@gmail.com
What processes are involved for a request to access data/document
Email: salehe.lotfi@gmail.com I'm responding as soon as possible
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