Protocol summary
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Study aim
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To determine the effect of exercise therapy with Swiss ball on the trunk control and balance in children with spastic cerebral palsy
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Design
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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.
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Settings and conduct
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The intervention is performed in the community rehabilitation and the finder. In this study, both the participants and the assessor are blind.
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Participants/Inclusion and exclusion criteria
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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 3 exclusion criteria include occurrence orthopedic events during treatment having body mass index above 25 and Ability to active straight leg raise and maintain the position until the abdominal muscle image is recorded
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Intervention groups
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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.
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Main outcome variables
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trunk control score
General information
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Reason for update
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In the inclusion criteria, the ability to raise the straight leg actively and maintain it when the ultrasound instrument records the abdominal muscle image is added. because during the study, it will be hard to record the image of the abdominal muscles in the hip flexion position by sonography instrument for children who do not have this ability. Moreover, Due to the decrease in the severity of the corona pandemic, the treatment at the patient's home is eliminated because the patients are referred to the Community Rehabilitation and the Finder for receiving physiotherapy services. Also, this center is added to the patient reception center. Additionally, in the sample randomization section, "cerebral palsy type" has been replaced by "gross motor function classification scale" because during the pilot study we realized that cerebral palsy children with moderate motor impairment severity (grade 3 of the gross motor function classification scale) who are able to perform hip flexion, and maintain it when the ultrasound instrument records the abdominal muscle image are rare.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140222016680N8
Registration date:
2021-05-14, 1400/02/24
Registration timing:
prospective
Last update:
2022-09-03, 1401/06/12
Update count:
1
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Registration date
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2021-05-14, 1400/02/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-01, 1400/05/10
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Expected recruitment end date
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2022-09-22, 1401/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of exercise therapy with Swiss ball on the trunk control and balance in children with spastic cerebral palsy
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Public title
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The effect of exercise therapy with ball in children with cerebral palsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
Ability to active straight leg raise and maintain it when the ultrasound instrument records the abdominal muscle image
Exclusion criteria:
Having a seizure is not controlled
Having a body mass index above 25 due to reduced reliability of ultrasonography images
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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: cerebral palsy type of diplegia and hemiplegia, the age range between 6 to 9 years and 9 to 12 years using 4 blocks. For concealment in the randomization process, a unique code will be used on each envelope.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-18, 1400/01/29
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Ethics committee reference number
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IR.IUMS.REC.1400.041
Health conditions studied
1
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Description of health condition studied
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spastic cerebral palsy
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ICD-10 code
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G80
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ICD-10 code description
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Cerebral palsy
Primary outcomes
1
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Description
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Trunk control score
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Timepoint
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Measurement of trunk control before intervention, after intervention and one month after the end of the intervention
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Method of measurement
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"Trunk Control Measurement Scale"
Secondary outcomes
1
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Description
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Balance score
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Timepoint
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Before intervention, after intervention and one month after the end of the intervention
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Method of measurement
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"Pediatric Balance Scale"
2
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Description
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Gross Motor Function Score
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Timepoint
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Before intervention, after intervention and one month after the end of the intervention
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Method of measurement
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Levels of D and E of the "Gross Motor Function Measurement"
3
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Description
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Functional Mobility Score
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Timepoint
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Before intervention, after intervention and one month after the end of the intervention
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Method of measurement
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"Pediatric Evaluation of Disability inventory"
4
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Description
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Abdominal Muscles Thickness
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Timepoint
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Before intervention, after intervention and one month after the end of the intervention
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Method of measurement
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Sonography
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available