To determine the effect of exercise therapy with Swiss ball on the trunk control and balance in children with spastic cerebral palsy
Design
This study is 2-armed, double-blind RCT with one to one allocation in two groups ( group 1: exercise with Swiss ball, group 2: trunk control exercise on the floor) in children with spastic cerebral palsy , where the person evaluating the outcome measures will be completely blind to the type of exercise each group will have receive. Additionally, participants will be blind because there is no difference between the two groups in terms of exercise positions, and duration treatment sessions.
Settings and conduct
The intervention is performed in the patient's house because of COVID-19 pandemic. In this study, both the participants and the assessor are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria include diagnosis of spastic hemiplegia/ diplegia, Having age range between 6 and 12 years old and Having motor function at levels between 1 and exclusion criteria include occurrence orthopedic events during treatment and having body mass index above 25.
Intervention groups
participants in intervention group, will receive "exercise with Swiss ball" and in control group, they will receive " trunk control exercise on floor" 5 weeks, three sessions per week.
Main outcome variables
trunk control score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140222016680N8
Registration date:2021-05-14, 1400/02/24
Registration timing:prospective
Last update:2021-05-14, 1400/02/24
Update count:1
Registration date
2021-05-14, 1400/02/24
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise therapy with Swiss ball on the trunk control and balance in children with spastic cerebral palsy
Public title
The effect of exercise therapy with ball in children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a diagnosis of spastic diplegia / hemiplegia as determined by a pediatric neurologist
Having age range between 6 and 12 years old
Having motor function at levels between 1 and 3 based on the "Gross Motor Function Classification Scale"
Ability to understand and follow verbal instructions
No severe visual or hearing impairment
Having a score above 70 in the "SPARCLE "questionnaire
Exclusion criteria:
Having a seizure is not controlled
Having a body mass index above 25 due to reduced reliability of ultrasonography images
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Stratification and Random blocks with four blocks will be used for randomization. The randomization type using the stratification method will be performed in four classes: GMFCS 1,2 and GMFCS 3, the age range between 6 to 9 years and the age group of 9 to 12 years using 4 blocks. For concealment in the randomization process, unique code will be used on each envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study ,Assessor who evaluates the outcome measures of study and the participants in the study will be blind to the allocation of the two treatment groups. Additionally the data also will be evaluated by a person who is blind to the allocation and treatment of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-04-18, 1400/01/29
Ethics committee reference number
IR.IUMS.REC.1400.041
Health conditions studied
1
Description of health condition studied
spastic cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Trunk control score
Timepoint
Measurement of trunk control before intervention, after intervention and one month after the end of the intervention
Method of measurement
"Trunk Control Measurement Scale"
Secondary outcomes
1
Description
Balance score
Timepoint
Before intervention, after intervention and one month after the end of the intervention
Method of measurement
"Pediatric Balance Scale"
2
Description
Gross Motor Function Score
Timepoint
Before intervention, after intervention and one month after the end of the intervention
Method of measurement
Levels of D and E of the "Gross Motor Function Measurement"
3
Description
Functional Mobility Score
Timepoint
Before intervention, after intervention and one month after the end of the intervention
Method of measurement
"Pediatric Evaluation of Disability inventory"
4
Description
Abdominal Muscles Thickness
Timepoint
Before intervention, after intervention and one month after the end of the intervention
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: In this group, exercises with Swiss ball, will be given in a period of 5 weeks, three sessions per week. Each treatment session starts with warming up and then special exercises are given with focus on improving trunk control in supine, prone, sitting, quadruped and standing positions and then it ends with cooling down. Each treatment session, depending on the patient needs to rest, lasts approximately 45 minutes. Required equipment are mats and gymnastics ball. Trunk control score, pediatric balance score, gross motor function score, functional mobility score, abdominal muscle thickness(internal oblique, external oblique and transverse abdomen ) at rest and hip flexion will be measured before the intervention, the last session of treatment and one month after the end of intervention.
Category
Rehabilitation
2
Description
Control group: Intervention group: In this group, trunk control exercises on floor, will be given in a period of 5 weeks, three sessions per week. Each treatment session starts with warming up and then conventional exercises are given with focus on improving trunk control in supine, prone, sitting, quadruped and standing positions and then it ends with cooling down. Each treatment session, depending on the patient needs to rest, lasts approximately 45 minutes. Required equipment are mats and chairs. Trunk control score, pediatric balance score, gross motor function score, functional mobility score, abdominal muscle thickness(internal oblique, external oblique and transverse abdomen ) at rest and hip flexion will be measured before the intervention, the last session of treatment and one month after the end of intervention.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurological physiotherapy Clinic, School of Rehabilitation Sciences, Iran University of Medical sci
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Fax
Email
noorizadeh.sh@iums.ac.ir
Web page address
http://www.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available