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IRCT20220630055330N1 IRCT 2022-10-25 Iran University of Medical Sciences The effects of group-based education of handling skills for parents with children with cerebral palsy on family empowerment and child’s functional mobility The effects of group-based education of handling skills for parents with children with cerebral palsy on family empowerment and child’s functional mobility 2022-07-23 anticipated 46 Complete https://irct.ir/trial/64534 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We plan to divide people based on the score of the GMFCS questionnaire into three categories with scores 1 and 2, with score 3 and with scores 4 and 5, and then to perform randomization in a way to select a number of samples from each of these categories almost equally in the intervention and control groups. First, by drawing a two-by-two table, we specify all the placement situations of the samples in the final groups: 1) intervention/control 2) control/intervention 3) intervention/intervention/control/control. Then, by lottery, one of these arrangement methods is selected and we exceed to the next step. In the next step, the ID of all the samples in the form of a code along with their GMFCS questionnaire scores are written on separate sheets and arranged randomly. Then in three envelopes (based on the scores of the GMFCS questionnaire, which had three categories with scores 1 and 2, with score 3 and with scores 4 and 5), on the sheets of the sorting system that was determined earlier (for example, intervention/intervention/control/control) In the same way, it is written separately and repetitively and placed inside triple envelopes. Then the sheets related to the ID of the samples (which apart from their ID code, also includes their GMFCS score) are revealed in order, and based on their GMFCS scores, we go to the desired envelope and take out the sorted sheets from inside it. Based on the writing on the pages inside the envelope (intervention or control), the target sample is randomly placed in one of the intervention or control groups, Blinding description: The evaluator will not know which group each sample belongs to in all stages of the evaluation. N/A Cerebral Palsy. Intervention 1: Intervention group: The members of this group, while receiving common occupational therapy interventions including active and passive stretching exercises to improve range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns and facilitate the child's movement functions with purposeful activities, they also benefit from 5 related workshop sessions in case of increasing family awareness of their child's condition and training appropriate techniques for handling and positioning him, the content of which is described in detail below. The first group session: During this one-hour session, the researcher will provide information on the nature of cerebral palsy, its causes, types and symptoms of each, functional levels, prognosis and related disorders, in addition to the introduction of drugs used to reduce spasticity and control convulsions and occupational therapy common interventions, through PowerPoint. The second group session: In this session, the researcher guides the parents to discuss and exchange opinions about the handling problems of their children, their musculoskeletal pain, the decrease in the quality of life of parents due to the child's illness, the decrease in the quality of the parent's health, the disruption of their occupational balance and related topics. The third group session: this session will be about children's functional problems in general; In this way, first the researcher explains the areas of occupational performance in the form of PowerPoint, and then parents are invited to express their challenges and the child's challenges in the introduced areas. 4th and 5th group session: By analyzing the discussions of the previous three group sessions that have been explained up to this point, the researcher has identified the basic problems that families are facing and prepares interventions for group training to parents in the form of PowerPoint, which will be presented in the fourth and fifth group sessions. It should be noted that there will be a suitable platform for discussion and exchange of parent's opinions, just like the previous group sessions. Intervention 2: Control group: The members of this group receive common occupational therapy interventions, including active and passive stretching exercises to improve the range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns, and facilitate the child's movement functions with purposeful and appropriate activities. The duration of providing common occupational therapy interventions commonly between the intervention and control groups will be 2 months (2 sessions per week and 45 minutes per session). 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 No more information.
public Pooya Reaei
Unit 3, No. 3, 3rd Piroozi Alley, Nikzare Ave., 22nd Bahman Ave., Ashrafi Esfahani Blvd., Bagh Feiz
Tehran Iran (Islamic Republic of) 1473178434 +98 21 4442 3675 pooya369@yahoo.com Iran University of Medical Sciences scientific Malek Amini
School of Rehabilitation Science, Madadkaran St., Shahid Shah Nazari St., Mother Square, Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 amini.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) The child has been diagnosed with spastic cerebral palsy by a neurologist The child does not have vision problems The child's family does not intend to perform any surgery during the implementation of interventions The mother of the child can be present as a parent of the participant in the study The mother (participant's parent) must be fluent in Persian and able to read 3 years 10 years Both The age of the child is less than 3 years or more than 10 years. G80 Cerebral palsy Rehabilitation Rehabilitation Intervention group: The members of this group, while receiving common occupational therapy interventions including active and passive stretching exercises to improve range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns and facilitate the child's movement functions with purposeful activities, they also benefit from 5 related workshop sessions in case of increasing family awareness of their child's condition and training appropriate techniques for handling and positioning him, the content of which is described in detail below. The first group session: During this one-hour session, the researcher will provide information on the nature of cerebral palsy, its causes, types and symptoms of each, functional levels, prognosis and related disorders, in addition to the introduction of drugs used to reduce spasticity and control convulsions and occupational therapy common interventions, through PowerPoint. The second group session: In this session, the researcher guides the parents to discuss and exchange opinions about the handling problems of their children, their musculoskeletal pain, the decrease in the quality of life of parents due to the child's illness, the decrease in the quality of the parent's health, the disruption of their occupational balance and related topics. The third group session: this session will be about children's functional problems in general; In this way, first the researcher explains the areas of occupational performance in the form of PowerPoint, and then parents are invited to express their challenges and the child's challenges in the introduced areas. 4th and 5th group session: By analyzing the discussions of the previous three group sessions that have been explained up to this point, the researcher has identified the basic problems that families are facing and prepares interventions for group training to parents in the form of PowerPoint, which will be presented in the fourth and fifth group sessions. It should be noted that there will be a suitable platform for discussion and exchange of parent's opinions, just like the previous group sessions. Control group: The members of this group receive common occupational therapy interventions, including active and passive stretching exercises to improve the range of motion and adjust muscle tone, facilitate gross and fine movement patterns in the form of developmental patterns, and facilitate the child's movement functions with purposeful and appropriate activities. The duration of providing common occupational therapy interventions commonly between the intervention and control groups will be 2 months (2 sessions per week and 45 minutes per session). Family empowerment score in the Family Empowerment Scale. Timepoint: Measuring family empowerment score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions. Method of measurement: Family Empowerment Scale. Gross motor function score in the Gross Motor Function Measurement. Timepoint: Measuring Gross motor function score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions. Method of measurement: Gross Motor Function Measurement - 88. Functional mobility score in the Mobility subscale of the Pediatric Evaluation of Disability Inventory. Timepoint: Measuring Functional mobility score for the first time at the beginning of the study, for the second time one month after the start of the study, for the third time two months after the start of the study (at the end of the interventions), for the fourth time one month after the end of the interventions and for the fifth time two months after the end of the Interventions. Method of measurement: Mobility subscale of the Pediatric Evaluation of Disability Inventory. Iran University of Medical Sciences Approved 2022-06-21 Ethics committee of Iran University of Medical Science Unit 3, No. 3, 3rd Piroozi Alley, Nikzare Ave., 22nd Bahman Ave., Ashrafi Esfahani Blvd., Bagh Feiz Tehran Tehran Iran (Islamic Republic of)