The purpose of this study is the effect of progressive resistance exercise on balance of 8-11 years old children with down syndrome. This study is an intervention study. By going to exceptional schools introduced by exceptional education and gaining the school officials' approval , 8-11 years old children with down syndrome with an IQ of 50-70 and with the mentioned conditions will appear in the study : 1-disparticipation of cases in the strength exercises in the last 3 months 2- not consuming any drugs which have effects on the muscles' strength 3- having normal optical & hearing abilities with/without auxiliary equipment Any kind of non cooperation discovered from the child or his/her parents will lead to the exclusion of the child from the study. Twenty children with down syndrome are divided in two control and intervention groups randomly. The cases in the intervention group have to participate in for 3 days per week , for 6 weeks. Every session takes 20 min. The cases in the control group will continue their regular activities followed at school. Before and after the intervention the child’s strength and balance will be evaluated and these data will be collected and assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204199517N1
Registration date:2012-07-06, 1391/04/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-06, 1391/04/16
Registrant information
Name
Tayebeh Sayadinezhad
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8474 1538
Email address
sayadinezhad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effect of progressive ressistance exercise in 8-11 years old children with down syndrome, with use of Bruininks Oseretsky Test
Public title
The effect of progressive ressistance exercise on children with down syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- age between 8 to 11 years old; 2-IQ between 50 to 70; 3- disparticipation of cases in the strength exercises in the last 3 months; 4- not consuming any drugs which have effects on the muscles' strength; 5- having normal optical & hearing abilities with/without auxiliary equipment; 6- not having any cardio_vascular disorders and 7- not having any neurology disorders Exclusion criterion: any kind of non cooperation discovered from the child or his/her parents.
Age
From 8 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran university of medical sciences
Street address
The center of students research, School of Medical Sciences, the third floor, Poursina street, Quds street,Enqelab Street
City
Tehran
Postal code
Approval date
2012-06-19, 1391/03/30
Ethics committee reference number
91-01-61-16981-56814
Health conditions studied
1
Description of health condition studied
down syndrome
ICD-10 code
f70
ICD-10 code description
Mild mental retardation
Primary outcomes
1
Description
Hip abductor and knee extensor muscles isometric strengths
Timepoint
Every 2 week
Method of measurement
Nicholas manual muscle test
2
Description
Balance
Timepoint
Pre and post intervention
Method of measurement
Balance subscale of Bruininks Oseretsky Test of Motor Proficiency
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: The subjects participated three times per week in a six-week, progressive, free-weight, strengthening programme. Free weights were used to provide resistance for the strength training in the form of adjustable weight cuffs attached by Velcro straps. For training, the children were positioned as for muscle strength testing with free weights. The training weight (TW) used in this study was 65% of the mean maximum isometric muscle strength value for each individual. Maximum strength was re-measured every two weeks during the six-week programme and the TW reset at 65% of the new value. At each TW the children progressed from three sets of five repetitions, to four sets of five, then three sets of ten as the number of repetitions became easy.
Category
Rehabilitation
2
Description
control group: wiil continue their regular activities followed at school
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Piruzi Center
Full name of responsible person
Mis . Khedmeti
Street address
Valiasr street, Pesyan street,Ardabili street
City
Tehran
2
Recruitment center
Name of recruitment center
Sayad shirazi Center
Full name of responsible person
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Ershad center
Full name of responsible person
Mr. Moqadam
Street address
Bridge Gisha, Patris lobumba street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotuhi
Street address
Vice chancellor for research, Tehran University of Medical Sciences
City
Tehran
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
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
Tehran University of Medical Sciences
Full name of responsible person
Sayadinezhad Tayebeh
Position
MSc candidate
Other areas of specialty/work
Street address
The center for students research, School of Medical Sciences, The third floor, Poursina street, Quds street, Enqelab Street
City
Tehran
Postal code
Phone
+98 936 744 6507
Fax
Email
sayadinezhad@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sayadinezhad Tayebeh
Position
MSc candidate
Other areas of specialty/work
Street address
The center for students research, School of Medical Sciences, The third floor, Poursina street, Quds street, Enqelab Street
City
Tehran
Postal code
Phone
+98 936 744 6507
Fax
Email
sayadinezhad@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sayadinezhad Tayebeh
Position
MSc candidate
Other areas of specialty/work
Street address
The center for students research, School of Medical Sciences, The third floor, Poursina street, Quds street, Enqelab Street
City
Tehran
Postal code
Phone
+98 936 744 6507
Fax
Email
sayadinezhad@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)