Protocol summary

Summary
Impaired motor perceptual skills in children with Down syndrome are common deficiency. Given the importance of motor perceptual skills in controlling the environment, participation, learning and performance of these children as activities which are done at school, home and in community, this study will investigate the impact of motor perceptual on motor perceptual function and drawing skills and dexterity in children with Down syndrome. In this survey, using a simple non-probability sampling, the sample size formulas and the laws of the Single System Design Study was considered approximately 5 children. Inclusion criteria include Educable Down Syndrome children with conform diagnosis by clinical psychologist, Educable Down Syndrome children without significant skeletal, neurological and mental illness and the age group is between 4.5 and 14.5 years. Exclusion criteria include non-cooperative child, Child injury accident in the length of treatment and Absence more than one session. They will be examined twice a week with 3 days interval. After further evaluation of the stability-oriented evaluations, along with the investigations, the Subjects treated for 1.5 months (3 times a week, an hour each session). The interventions include motor perceptual and visual perception exercise. Assessments continue twice a week. After completion of the study and statistical analyze, the effect of treatment on motor perceptual skills is examine. This study is single blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013040510387N3
Registration date: 2013-06-03, 1392/03/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-03, 1392/03/13
Registrant information
Name
Shahla Rafiee
Name of organization / entity
Tehran University Rehabilitation College
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
sh_rafiee@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences, 4th Floor, Tehran University Central Building, Keshavarz Blvd, Tehran, Iran.
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of perceptual motor exercises on motor perceptual function, dexterity and drawing skills of children with down syndrome
Public title
The effect of motor perceptual exercises on children with down syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: - Educable Down Syndrome children with conform diagnosis by clinical psychologist - Educable Down Syndrome children without significant skeletal, neurological and mental illness, significant attention deficit disorder, epilepsy and other disease such as musculoskeletal and neurological disease and fractures and so on. - The age group is between 4.5 and 14.5 Exclusion criteria: - non-cooperative child - Child injury accident in the length of treatment - Absence more than one session
Age
From 5 years old to 14 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This survey is a blind test and examiners are unaware about study process.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Tehran University of Medical Sciences
Street address
4th Floor, Tehran University of Medical Sciences Central Building, Keshavarz Blvd
City
Tehran
Postal code
1545913487
Approval date
2013-01-01, 1391/10/12
Ethics committee reference number
18882

Health conditions studied

1

Description of health condition studied
Mental Retarded, Down Syndrome
ICD-10 code
F70
ICD-10 code description
Approximate IQ range of 50 to 69 (in adults, mental age from 9 to 12 years). Likely to result in some learning difficulties in school. Many adults will be able to work and maintain good social relationships and contribute to society.

Primary outcomes

1

Description
Motor perceptual skills
Timepoint
Before and after intervention
Method of measurement
Bruininks RH. Bruininks _Oseretsky Test

Secondary outcomes

1

Description
Dexterity of upper limb
Timepoint
Before and after intervention
Method of measurement
Purdue peg board Test

2

Description
Drawing skills
Timepoint
Before and after intervention
Method of measurement
Slowsen's test

Intervention groups

1

Description
The intervention included perceptual motor (Balance, gross, fine and coordination movement exercise) and visual perception exercise. These exercises are designed from easy to hard. Subjects for 1.5 month, 3 sessions per week for 60-minute exercises; balance training (15 minutes), gross motor (15 minutes), fine (15 minutes) and movement coordination (15 minutes) are taught.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghods Special School
Full name of responsible person
Ghamari Narges
Street address
Shaghayegh Alley, Shahbodaghiyan Street
City
Ghods

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Fotouhi
Street address
4th Floor, Tehran University Central Building, Keshavarz Blvd
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 research, 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
Education and Training
Full name of responsible person
Ghamari Narges
Position
Occupational Therapist/Occupational Therapy
Other areas of specialty/work
Street address
Shaghayegh Alley, Shahbodaghiyan Street
City
Ghods
Postal code
3751113885
Phone
+98 21 4688 5900
Fax
+98 21 4681 6374
Email
Nargesghamari@yahoo.com
Web page address
No

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical Sciences
Full name of responsible person
Rafiee Shahla
Position
Master of Health Education
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad Blvd.
City
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
Sh_rafiee@farabi.tums.ac.ir
Web page address
No

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation Faculty, Tehran University of Medical
Full name of responsible person
Rafiee Shahla
Position
Mentor-Master of Sciences
Other areas of specialty/work
Street address
Shahnazari Street, Mirdamad Blvd.
City
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
Sh_rafiee@farabi.tums.ac.ir
Web page address
No

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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