Protocol summary

Study aim
The effect of a course of perceptual-motor exercises on ground reaction force components in mentally retarded children during walking
Design
Clinical trial without control group, using G * POWER software The statistical sample of the present study includes 16 female students who will be available as a sample and will participate in this study voluntarily.
Settings and conduct
Measurements were performed at Mohaghegh Ardabili University Health Center.The subjects walked on the force plate with normal steps. The perceptual-motor training program was performed for 8 weeks and three sessions per week.Ground reaction force components were re-measured during walking.
Participants/Inclusion and exclusion criteria
Inclusion criteria were trainability, no brain injury, no history of orthopedic injury, fracture, lower limb dislocation, dizziness, Down syndrome, and no previous participation in perceptual-motor exercises. If for any reason the subject did not want to continue cooperating in the research, he would be excluded from the research.
Intervention groups
perceptual-motor exercises
Main outcome variables
Reduces injury to the lower limbs; Improving gait quality in mentally retarded children

General information

Reason for update
Acronym
MR
IRCT registration information
IRCT registration number: IRCT20190302042881N2
Registration date: 2020-10-12, 1399/07/21
Registration timing: registered_while_recruiting

Last update: 2020-10-12, 1399/07/21
Update count: 0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Mohsen Barghamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5652
Email address
barghamadi@uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2020-10-21, 1399/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a course of perceptual-motor exercises on ground reaction force components in mentally retarded children during walking
Public title
The effect of a course of perceptual-motor exercises on ground reaction force components in mentally retarded children during walking
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 9-12 years educable No brain damage do not have any history of orthopedic injury and Fracture do not have Down syndrome do not have Dizziness do not have dislocation of the lower limb No previous participation in perceptual-motor exercises
Exclusion criteria:
Reluctance to continue collaborating in research
Age
From 9 years old to 12 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah st, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Approval date
2019-07-20, 1398/04/29
Ethics committee reference number
IR.ARUMS.REC.1398.198

Health conditions studied

1

Description of health condition studied
mentally retarded children
ICD-10 code
F06
ICD-10 code description
Other mental disorders due to known physiological condition

Primary outcomes

1

Description
ground reaction force components
Timepoint
pretest before training and post test after eight weeks training
Method of measurement
ground reaction force variables were measured using a force plate device.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: perceptual motor exercises included: Exercise program for 8 weeks and three sessions per week and each session for 50 minutes including warm-up for 10 minutes, specific perceptual-motor movement for 15 minutes, combined activities and perceptual-motor professions for 15 minutes. cool down was performed for 10 minutes.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Mohaghegh Ardabili Health Center
Full name of responsible person
Mohsen Barghamadi
Street address
University of Mohaghegh Ardabili, daneshgah St, Ardadil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Abolfazl Bezaatpoor
Street address
Daneshgah St, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
a_bezaatpour@yahoo.com
Web page address
https://uma.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Barghamadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Daneshgah St, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Barghamadi
Position
Associate proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Daneshgah St, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohsen Barghamadi
Position
Associate profferor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Daneshgah St, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5652
Email
barghamadi@uma.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
mean of ground reaction forces
When the data will become available and for how long
When publishing an article
To whom data/document is available
All people
Under which criteria data/document could be used
it is free.
From where data/document is obtainable
The journal in which the article will publish.
What processes are involved for a request to access data/document
Journal Process and Rules
Comments
Null
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