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Effect of circuit training on some physiological factors, lower leg muscle activity, gross motor function and activity daily living on spastic cerebral palsy children

Protocol summary

Study aim
Effect of circuit training on some physiological factors, lower leg muscle activity, gross motor function and activity daily living on spastic cerebral palsy children
Design
In this study, 34 children with cerebral palsy will be voluntarily attended. Which are randomly divided into two groups of experimental group (n=17) and control group (n=17).
Settings and conduct
The present study is a randomized controlled trial on children with cerebral palsy in Rasht city. Subjects will attend a circular exercise program for 12 weeks. Measurement of some physiological factors, lower extremity muscle activity, gross motor function and daily life activity, before and after 12 weeks of circular training will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having age ranges of 7-16 years Spastic diplegia cerebral palsy Ambulation ability Exclusion criteria: More than three session absence from the training Botox injection or surgery in period of intervention
Intervention groups
Intervention group: 12 weeks of high intensity circuit training, three sessions per week, in each training session of 3 round of training circle, which consists of 6 training stations, with 30 seconds of exercise and 30 seconds break between, them as: sit to stand exercise, heel rises, forward lunges, and a lateral step-up exercise, lifting the medicine ball of the floor and placing on the chair and a motivational game station throwing off the ball Within the basket of 5 meters from a warm-up at the beginning of the session and a cool down at the end of the session. In addition 12 weeks and one session per week of normal occupational therapy training Control group: 12 weeks and one session per week of normal occupational therapy
Main outcome variables
Gross Motor Function and Lower leg muscle activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022498N33
Registration date: 2020-06-06, 1399/03/17
Registration timing: retrospective

Last update: 2020-06-06, 1399/03/17
Update count: 0
Registration date
2020-06-06, 1399/03/17
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of circuit training on some physiological factors, lower leg muscle activity, gross motor function and activity daily living on spastic cerebral palsy children
Public title
Effect of circuit training on cerebral palsy children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having age ranges of 7-16 years Spastic diplegia cerebral palsy Ambulation ability
Exclusion criteria:
More than three session absence from the training Botox injection or surgery in period of intervention
Age
From 7 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a randomized controlled trial that thirty four children were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 17 people using a lottery by simple random method.
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 Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.IAU.RASHT.REC.1399.005

Health conditions studied

1

Description of health condition studied
Cerebral Palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
Gross Motor Function
Timepoint
Before an after of end of intervention
Method of measurement
Using Gross Motor Function Measure (GMFM)

2

Description
Lower leg muscle activity
Timepoint
Before an after of end of intervention
Method of measurement
Using Electromyography device ( EMG and evoked-potentialemg-meb-9400k )

Secondary outcomes

1

Description
Body composition
Timepoint
before and after the end of intervention
Method of measurement
With the use of weights, height, gender and SAEHAN Hand Calipers and the Slater Kids Body Composition formula

2

Description
Strength
Timepoint
Before an after of end of intervention
Method of measurement
Using SAEHAN Hand-Grip Dynamometer and SAEHAN Back, Leg & Chest Dynamometer

3

Description
Balance
Timepoint
Before an after of end of intervention
Method of measurement
Using Berg Balance Scale

4

Description
6 Minute Walk Distance
Timepoint
Before an after of end of intervention
Method of measurement
6 Minute Walk Test

5

Description
Activity Daily Living
Timepoint
Before an after of end of intervention
Method of measurement
Using Activity Scale for Kids (ASK)

Intervention groups

1

Description
Intervention group: 12 weeks of high intensity circuit training, three sessions per week, in each training session of 3 round of training circle, which consists of 6 training stations, with 30 seconds of exercise and 30 seconds break between, them as: sit to stand exercise, heel rises, forward lunges, and a lateral step-up exercise, lifting the medicine ball of the floor and placing on the chair and a motivational game station throwing off the ball Within the basket of 5 meters from a warm-up at the beginning of the session and a cool down at the end of the session. in addition 12 weeks and one session per week of normal occupational therapy training
Category
Rehabilitation

2

Description
Control group: 12 weeks and one session per week of normal occupational therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tavan Ocupational Therapy Center
Full name of responsible person
Arash Nasiri Woshmesaraei
Street address
4th Alley, After sadeghinezhad gas station, Gholipour Blvd, Rasht
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
Arashnasiriot@yahoo.com

2

Recruitment center
Name of recruitment center
Mehrpouya physical disability education and rehabilitation center
Full name of responsible person
Negar Rad Nosrati
Street address
خیابان استقامت دوم، کوچه شهید مراد بلال زاده، پلاک90
City
Rasht
Province
Guilan
Postal code
4146745863
Phone
+98 13 3355 2897
Email
Arashnasiriot@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Occupational therapy center
Full name of responsible person
Arash Nasiri Woshmesaraei
Street address
No. 4, 4th Alley, after Sadeghinejad gas station, Gholipour Blvd.
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
arashnasiriot@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Occupational therapy center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Nasiri Woshmesaraei
Position
phd student
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
arashnasiriot@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tavan Occupational Therapy Center
Full name of responsible person
Arash Nasiri Woshmesaraei
Position
Occupational Therapist
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
No. 4, 4th Alley, after Sadeghinejad gas station, Gholipour Blvd.
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
arashnasiriot@yahoo.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
No decision has been made yet.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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