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IRCT20140222016680N10 IRCT 2024-09-05 Iran University of Medical Sciences Comparison of two trunk stabilization training on mobility, trunk control, muscle stiffness and grip strength in cerebral palsy children DNS (Dynamic Neuromuscular Stabilization) and CS (Core Stability) Comparison of the effect of "Dynamic Neuromuscular Stabilization" training and "Core Stability" training on mobility, trunk control, hypertonicity and grip strength in children with spastic hypertonia cerebral palsy 2024-09-22 anticipated 38 Complete https://irct.ir/trial/78082 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 38, approximately10 blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope with the type of training specified inside, Blinding description: In this study, the assessor who evaluates the outcome measures of the study, will be blind to the allocation of the two treatment groups. َAditionally, 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, Dynamic Neuromuscular Stabilization exercises, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 21 exercises are given with focus on improving trunk control in supine, prone, sitting, quadruped and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 40 and 60 minutes. Required equipment are mats, gymnastics ball, chair , and wall bar. Intervention 2: Control group: Core Stability exercises a period of 5 weeks, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 16 exercises are given with focus on improving trunk control in supine, prone, sitting, and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 40 and 60 minutes. Required equipment are mats, gymnastics balls, chair and wall bar. 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) • Confirming the diagnosis of participants as spastic hypertonia CP (hemiplegic), diplegic CP, hemiparesis, by the neurologist • Having Motor Function levels between 1 and 3 based on the GMFCS • Having age range between 7 and 11 years old • Able to follow verbal commands • Ability to walk as much as 3 meter with/without walking aid • Have not received Botox within 6 months in upper and lower limb 7 years 11 years Both Children with other serious neuromuscular disorders such as neuropathies, myopathies Having apraxia (Inability to learn and practice exercises) Having a history of a major surgery on the elbows, wrists, and fingers Having any cardiovascular disease Having involuntary movements Having severe contractures and deformities in the limbs Having serious hearing and speech problems Having uncontrolled diabetes Explicit postural abnormalities in the spine and lower limbs such as scoliosis and kyphosis G80 Cerebral Palsy Rehabilitation Rehabilitation Intervention group: In this group, Dynamic Neuromuscular Stabilization exercises, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 21 exercises are given with focus on improving trunk control in supine, prone, sitting, quadruped and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 40 and 60 minutes. Required equipment are mats, gymnastics ball, chair , and wall bar. Control group: Core Stability exercises a period of 5 weeks, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 16 exercises are given with focus on improving trunk control in supine, prone, sitting, and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 40 and 60 minutes. Required equipment are mats, gymnastics balls, chair and wall bar. "Mobility Score". Timepoint: Before intervention, after intervention. Method of measurement: "Timed Up and Go Test". Trunk control score. Timepoint: Measurement of trunk control before intervention, after intervention. Method of measurement: "Trunk Control Measurement Scale". Hypertonia Score. Timepoint: before intervention, after intervention. Method of measurement: "Modified Ashworth Scale". Grip Strength Score. Timepoint: before intervention, after intervention. Method of measurement: "Grip Dynamometer". Iran University of Medical Sciences Approved 2024-08-13 Ethic committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)