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IRCT20140222016680N8 IRCT 2021-05-14 Iran University of Medical Sciences The effect of exercise therapy with ball in children with cerebral palsy The effect of exercise therapy with Swiss ball on the trunk control and balance in children with spastic cerebral palsy 2021-08-01 anticipated 30 Complete https://irct.ir/trial/55541 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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: 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, 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. N/A spastic cerebral palsy. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences scientific Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 6 years 12 years Both Having a seizure is not controlled Having a body mass index above 25 due to reduced reliability of ultrasonography images G80 Cerebral palsy Rehabilitation Rehabilitation 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. 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. 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". Balance score. Timepoint: Before intervention, after intervention and one month after the end of the intervention. Method of measurement: "Pediatric Balance Scale". 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". 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". Abdominal Muscles Thickness. Timepoint: Before intervention, after intervention and one month after the end of the intervention. Method of measurement: Sonography. Iran University of Medical Sciences Approved 2021-04-18 Ethic committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)