To evaluate the effects of balance board on the balance parameters in children with spastic cerebral palsy
Design
single-group before-after clinical trial.
Settings and conduct
The study was conducted in the Department of Physical Medicine and Rehabilitation at a teaching hospital.
Participants/Inclusion and exclusion criteria
children with a diagnosis of spastic CP if they were between 5 and 15 years of age. They were required to have bilateral spastic CP based on the Modified Ashworth Scale of 1+ or 2
Intervention groups
we place the patients on a force plate and examine the balance and balance parameters (Body Sway, Maximum Overshoot, CoP Distance, and CoP Velocity). Patients were then trained in 20 sessions of 45 minutes for 3 times a week with a balance plate.
Main outcome variables
distance, velocity, and overshoot of the center of pressure displacement with eyes open and closed
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140306016865N3
Registration date:2020-09-24, 1399/07/03
Registration timing:retrospective
Last update:2020-09-24, 1399/07/03
Update count:0
Registration date
2020-09-24, 1399/07/03
Registrant information
Name
Mahsa Asheghan
Name of organization / entity
Baqiatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8805 8837
Email address
m_asheghan@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of balance board training on balance parameters in children with Spastic Paraparesis of cerebral palsy
Public title
The effect of balance board training in children with cerebral palsy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with CP type spastic diplegia (SDI),
aged 5 to 15 years
Exclusion criteria:
Other causes for sapsticity
concomitant medica ldiseases
Botox injection during 6 months ago
Age
From 5 years old to 15 years old
Gender
Both
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
No comment
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of Medical Sciences
Street address
Mollasadra Street
City
Tehran
Province
Tehran
Postal code
1436913511
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
ir.bmsu.rec.1396.481
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
The amount of center of the pressure displacement on the balance board in centimeters with the eyes open and closed
Timepoint
At the baseline and one week after the end of the intervention
Method of measurement
Using force plate and graphic software
2
Description
Speed of center of gravity movement with eyes open and closed
Timepoint
At the baseline and one week after the end of the intervention
Method of measurement
Using force plate and graphic software
Secondary outcomes
empty
Intervention groups
1
Description
We placed the patients on a force plate (using the force plate plate of the Kistler model 2812A and version 4.0 X with a frequency of 1200 Hz) We examined the balance position and balance parameters (CoP Velocity max, Overshoot COP, CoP Displacemente and CoP Velocity. Then, the patients were trained in 20 sessions of 45 minutes 3 times a week with a balance plate (balance board device made by Pegah Parseh Research Institute). At the end of the work (one week after the end of the treatment sessions), they were placed on the force plate again as before and their balance status and balance parameters were checked.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqyiatallah Hospital
Full name of responsible person
Mahsa Asheghan
Street address
Mollasadra Street
City
Tehran
Province
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8482 4353
Email
research2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Mollasadra street
City
Tehran
Province
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Mollasadra Street
City
Tehran
Province
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Email
m_asheghan@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mahsa Asheghan
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Mollasadra Street
City
Tehran
Province
Tehran
Postal code
1436913511
Phone
+98 21 8805 8837
Email
m_asheghan@bmsu.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
Not applicable
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
The study will be published in an article
When the data will become available and for how long
just after publication
To whom data/document is available
researchers
Under which criteria data/document could be used
for research purpose
From where data/document is obtainable
from the indexing journal website
What processes are involved for a request to access data/document