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IRCT20191109045376N1 IRCT 2020-07-16 Iran University of Medical Sciences Investigating the effect of using activity analysis strategy when using m-CIMT Effect of occupation-based modified constraint-induced movement therapy on participation children with cerebral palsy: A double-blind randomized controlled trial 2020-07-22 anticipated 30 Complete https://irct.ir/trial/48925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: A stratified randomization is performed to assign children to groups. Two categories, MACS level I and II and MACS level III, are included in the table of random numbers. Plaques are enclosed in matte numbered sealed envelopes that are stored by the therapist, Blinding description: In this study, the assessor will be blind at all stages, the assessment before the intervention, the assessment after the intervention, and the assessment at the time of follow-up, and the assessor will not know which group each child is in. Also, parents and clients will not be informed about the assignment in the groups. N/A cerebral palsy. Intervention 1: Intervention group: Based on the set goals, the child will be analyzed on the basis of OTPF motor skills items. Then, based on the child's defects based on OTPF activity analysis items, according to the interests of each child, a treatment plan in the form of play and activities of daily living is designed and graded based on the principles of motor learning by the therapist and given to parents to practice with the child. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will be treated at home for 4 weeks, 3 days a week and 1 hour a day by the parents according to the program prepared by the therapist, during this time the less affected upper extrimity will be restricted by the strap. Also, a less affected upper extrimity will be restricted to 5 to 6 hours apart from interventions during activities of daily living. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing M-CIMT interventions based on activity analysis), parents will be given the necessary feedback. Intervention 2: Control group: According to the child's interests, the treatment plan in the form of play and activities of daily living is designed and graded (being more difficult) based on principles of motor learning by the therapist and given to the parents to practice with the child at home. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will receive routine m-CIMT interventions (without activity analysis and no emphasis on defects in OTPF activity analysis items when performing this technique); The duration of the interventions will be the same as the intervention group for 4 weeks, 3 days a week and 1 hour per day. Also, less affected upper extremity will be restricted 5 to 6 hours apart from interventions during daily life activities. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing routine m-CIMT interventions without activity analysis), parents will be given the necessary feedback. 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 Malek Amini
Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 1545913487 0098 21 222228051 malekamini8@gmail.com Iran University of Medical Sciences scientific Malek Amini
Madadkaran St., Shah Nazari St., Madar Square, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 1545913487 0098 21 222228051 malekamini8@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) The child has been diagnosed by a neurologist with cerebral palsy The child has levels I, II and III of the MACS scale The child can actively extend the wrist of the affected limb by 20 degrees The child can actively extend the fingers of the affected limb by 10 degrees The child achieve score above 44 in PBS test The child does not have vision problems The child does not have a behavioral problem that can withstand the restriction The child's IQ is above 70 The child has not received upper limb surgery and Botox injections in the past 6 months and does not intend to do so during the interventions 5 years 12 years Both Lack of desire of family or child to continue interventions G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Intervention group: Based on the set goals, the child will be analyzed on the basis of OTPF motor skills items. Then, based on the child's defects based on OTPF activity analysis items, according to the interests of each child, a treatment plan in the form of play and activities of daily living is designed and graded based on the principles of motor learning by the therapist and given to parents to practice with the child. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will be treated at home for 4 weeks, 3 days a week and 1 hour a day by the parents according to the program prepared by the therapist, during this time the less affected upper extrimity will be restricted by the strap. Also, a less affected upper extrimity will be restricted to 5 to 6 hours apart from interventions during activities of daily living. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing M-CIMT interventions based on activity analysis), parents will be given the necessary feedback. Control group: According to the child's interests, the treatment plan in the form of play and activities of daily living is designed and graded (being more difficult) based on principles of motor learning by the therapist and given to the parents to practice with the child at home. Parents will also be given the necessary training (the nature and manner of doing exercises such as shaping, hardening, and repetition) to perform interventions at home. Participants in this group will receive routine m-CIMT interventions (without activity analysis and no emphasis on defects in OTPF activity analysis items when performing this technique); The duration of the interventions will be the same as the intervention group for 4 weeks, 3 days a week and 1 hour per day. Also, less affected upper extremity will be restricted 5 to 6 hours apart from interventions during daily life activities. At the end of each session, the therapist will call with each parents and asked about the time limit and activities during intervention restriction time and other restriction time and activities are done by child in non-restricted time, and based on the purpose of the study (performing routine m-CIMT interventions without activity analysis), parents will be given the necessary feedback. The score obtained is related to the two categories of satisfaction and performance in the canadian occupational performance measure questionnaire. Timepoint: Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention. Method of measurement: Canadian occupational performance measure questionnaire. Score obtained from the amount of goal achievement by the goal attainment scaling tool. Timepoint: Measure participation at the beginning of the study (before the intervention), 1 and 3 months after the start of the intervention. Method of measurement: goal attainment scaling. Score obtained in the ABILHAND-Kids questionnaire. Timepoint: Measure manual ability at the beginning of the study (before the intervention), 1 and 3 months after the intervention. Method of measurement: ABILHAND-Kids questionnaire. Score obtained in the pediatric motor activity log questionnaire. Timepoint: Measure manual ability at the beginning of the study (before the intervention), 1 and 3 months after the intervention. Method of measurement: pediatric motor activity log questionnaire. Iran University of Medical Sciences Approved 2020-04-15 Ethics committee of IranUniversity of Medical Sciences No. 39, Unit 5, Asadi Alley, between Jeyhun and Zanjan, Toos St. Tehran Tehran Iran (Islamic Republic of)