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IRCT20230626058589N1 IRCT 2023-07-23 Shahid Beheshti University of Medical Sciences The Effects of Horse Riding Simulator on the Balance, postural control and Hip in Children with Bilateral Spastic Cerebral Palsy The Effects of Horse Riding Simulator on the Balance, postural control and Hip Adductor Spasticity in Children with Bilateral Spastic Cerebral Palsy: A Single Blind Randomized Control Trial 2023-07-01 anticipated 36 Complete https://irct.ir/trial/70928 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The present study is a randomized clinical trial of one sucur. The number of 36 children with spastic cerebral palsy was selected from the available population and after filling the consent form, using the block randomization method and considering the number of samples required from the sample size formula. People are divided into two equal groups. (group receiving simulated hippotherapy along with routine treatment and control group receiving routine treatment). In children with GMFCS II, III levels, children with GMFCS II will be in one group and children with GMFCS III will be placed in a separate group. Then 9 people from each group are selected randomly and using envelopes and randomly enter the control and intervention groups to make sure that an equal number of each GMFCS will be placed in each group. In this method, we select a number of cards as the intervention group and the same number of cards for the control group, then we mix the cards together and spend one card, and its allocation is recorded, and after spending the card, it is returned to the group of other cards. Then the cards are merged again and we take out another card. This process continues until reaching a random sequence according to the sample size. This method will be done separately for both groups with different levels of GMFCS. In this research, the control and intervention group meetings are held on different days so that children and families remain unaware of the child's presence in the control and intervention groups. Also, the occupational therapist who did the evaluations is not aware of the classification of the patients, Blinding description: The evaluator will be completely blinded to the individuals of each group in all phases of evaluation, including initial evaluation, post-treatment evaluation, and follow-up. N/A Children with Bilateral Spastic Cerebral Palsy. Intervention 1: Intervention group: In the therapist intervention group, in addition to routine occupational therapy interventions, there are common treatments for children with cerebral palsy, which include traditional neurodevelopmental approaches (Bobath), Rood, sensory integration, splints, and strength-enhancing exercises. The simulated horse riding device will also be used in order to benefit from simulated hippotherapy. In this way, out of the 45 minutes of occupational therapy, the therapist will spend half an hour on common treatments and occupational therapy routines, and the last 15 minutes will be spent using simulated hippotherapy. Intervention 2: Control group: In the control group, during the 45-minute occupational therapy sessions, the therapist will only use common and routine occupational therapy treatments, including stretching exercises, strength exercises, vestibular and sensory stimulations. No - There is not a plan to make this available Justification or reason for not sharing IPD is To comply with the principle of trust
public Kiana Ramezani
Shahid Beheshti University of Medical Sciences, Damavand Street, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 kianaramezani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Kiana Ramezani
Shahid Beheshti University of Medical Sciences, Damavand Street, Imam Hossein Square, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 kianaramezani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The child has been diagnosed with spastic cerebral palsy (diplegia, double hemiplegia, and quadriplegia) by a neurologist. The child must be in one of the levels II and III of the classification system of gross movements so that they have the ability to sit and can hold themselves on the saddle. The child does not have behavioral problems and can tolerate sitting on the simulated horse (assessed by interviewing the parents and observing). The child's IQ score, which will be measured by Sparkle, should be above 70. The child has not performed any surgery on the adductors and does not intend to perform it during the implementation of interventions. The child has not received botox injection in the last 6 months and does not intend to do it during the implementation of interventions. Children should not have dislocation or subluxation in the pelvis. The child does not have seizures, especially uncontrolled seizures or epilepsy. The child does not have problems with the vestibular system (children who cannot tolerate vestibular stimulation, which is determined by clinical evaluation by the therapist and interview.) The child does not have a history of receiving any hippotherapy or simulated hippotherapy services during the past year. have received a spasticity score of 1 and +1 in MAS 5 years 9 years Both G80 Cerebral palsy Rehabilitation Rehabilitation Intervention group: In the therapist intervention group, in addition to routine occupational therapy interventions, there are common treatments for children with cerebral palsy, which include traditional neurodevelopmental approaches (Bobath), Rood, sensory integration, splints, and strength-enhancing exercises. The simulated horse riding device will also be used in order to benefit from simulated hippotherapy. In this way, out of the 45 minutes of occupational therapy, the therapist will spend half an hour on common treatments and occupational therapy routines, and the last 15 minutes will be spent using simulated hippotherapy. Control group: In the control group, during the 45-minute occupational therapy sessions, the therapist will only use common and routine occupational therapy treatments, including stretching exercises, strength exercises, vestibular and sensory stimulations. Balance. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Pediatric Balance Scale. Postural control of the trunk. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Trunk Control Measurement Scale. Spasticity. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Modified Ashworth Scale. Gross motor function. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Gross Motor Function Measure. Functional mobility. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Pediatric Evaluation of Disability Inventory. Joint range of motion. Timepoint: At the beginning of the study, 30 days after the start of the intervention and 60 days after the end of the intervention. Method of measurement: Goniometry. Shahid Beheshti University of Medical Sciences Approved 2023-06-11 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Damavand Street, Imam Hossein Square, Tehran Tehran Tehran Iran (Islamic Republic of)