To study the role of challenge point framework intervention in learning stepping reaction and dynamic balance in 4-12 years old children with unilateral cerebral palsy
Design
One intervention group, pre-test/post-test. 12 participants
Not blinded
Settings and conduct
Study was performed in occupational therapy clinics in Tehran
Participants/Inclusion and exclusion criteria
The criteria for entering the study were the ability to walk without the help of a person or assistive device for at least six minutes, the ability to understand and follow the therapist's guidelines, and levels one to three of the GMFCS
Convulsion during the study or any disease that interfered with the study process, failure to attend three consecutive sessions, refusing to complete the training sessions, heart disease, and severe vision or hearing problems were exclusion criteria.
Intervention groups
One intervention group, pre-test/post-test
. In this procedure, the person was asked to bend from the ankle joint in four directions, forward, backward, right and left, while standing. People should not try to prevent falling, but should allow themselves to fall like a fallen tree, to the point where they feel they have to take a step to prevent it from falling.
To reduce the fear of falling, participants were encouraged to concentrate on increasing the speed and length of the stepping reaction so as not to pay attention to the limits of their stability (by the therapist). People had similar exercises with both legs as the initial stepping leg in maintaining balance. Although they could take as many steps as they need to regain balance, they were encouraged to keep their balance in just two to three steps.
Main outcome variables
Step length in stepping reaction
Step velocity in stepping reaction
Dynamic balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048619N1
Registration date:2020-09-09, 1399/06/19
Registration timing:retrospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Somayeh Ashouri
Name of organization / entity
Kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 3373 3247
Email address
so_ashouri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-07, 1398/06/16
Expected recruitment end date
2019-09-17, 1398/06/26
Actual recruitment start date
2019-09-07, 1398/06/16
Actual recruitment end date
2019-09-17, 1398/06/26
Trial completion date
2019-12-10, 1398/09/19
Scientific title
Use of Challenge Point Framework to Guide Motor Learning of Stepping Reactions for Improved Balance Control in Children with Unilateral Cerebral Palsy
Public title
To study the role of CPF motor learning on balance control in hemiplegic CP children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to walk without the help of a person or assistive device for at least six minutes
Ability to understand and follow the therapist's guidelines
Levels one to three of the GMFCS
Hemiplegic cerebral palsied children aged 4 to 12
Exclusion criteria:
Convulsion during the study or any disease that interfered with the study process. ,
Failure to attend three consecutive sessions
Heart disease, and severe vision or hearing problems
Refusing to complete the training sessions
Age
From 4 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Actual sample size reached:
12
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
Ethics committee of research of Kharazmi university
Balance disorder in unilateral cerebral palsied children
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Step length in stepping reaction
Timepoint
Pre-test1, pre-test2, post-test
Method of measurement
Tracker software to estimate step length
2
Description
Step velocity in stepping reaction
Timepoint
Pre-test1, pre-test2, post-test
Method of measurement
Tracker software to estimate step velocity
3
Description
Statics and Dynamic balance
Timepoint
Pre-test1, pre-test2, post-test
Method of measurement
Pediatric Balance Scale (PBS) to test static and dynamic balance
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: received 12 sessions (twice a week) exercises based on challenge point framework. Each session lasted for 45 minutes. In this procedure, the person was asked to bend from the ankle joint in four directions, forward, backward, right and left, while standing. People should not try to prevent falling, but should allow themselves to fall like a fallen tree, to the point where they feel they have to take a step to prevent it from falling.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehravaran Rehabilitation and Occupational Therapy Clinic
Full name of responsible person
Hossein Ashouri
Street address
N.47, Abouzar 6th bridge,Pirouzi Ave.
City
Tehran
Province
Tehran
Postal code
1779843636
Phone
+98 21 3320 9778
Email
H_ashouri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi university
Full name of responsible person
Amir Letafatkar
Street address
Kharazmi university, Kousha St.,Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 2222 8001
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi university
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
Kharazmi university
Full name of responsible person
Somayeh Ashouri
Position
Student
Latest degree
Master
Other areas of specialty/work
Therapeutic Exercises
Street address
Kharazmi university, Kousha St., Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 2222 8001
Email
so_ashouri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Somayeh Ashouri
Position
Student
Latest degree
Master
Other areas of specialty/work
Therapeutic Exercises
Street address
Kharazmi university, Kousha St.,Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 2222 8001
Email
so_ashouri@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Somayeh Ashouri
Position
Student
Latest degree
Master
Other areas of specialty/work
Therapeutic Exercises
Street address
Kharazmi university, Kousha St., Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 2222 8001
Email
so_ashouri@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available