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IRCT20241123063805N1 IRCT 2024-12-08 Iran University of Medical Sciences Effect of adapted Cognitive Orientation to daily Occupational Performance approach on spastic cerebral palsy children The effect of adapted Cognitive Orientation to daily Occupational Performance (CO-OP) approach by adding self-controlled video feedback on the upper limb Occupational Performance of children with spastic cerebral palsy 2025-01-20 anticipated 39 Complete https://irct.ir/trial/80318 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Considering that Manual Ability Classification System (MACS) levels one to three have been determined as the criteria for entering the research, and on the other hand, it is the main dependent variable of studying the occupational performance of the upper limb therefore for the random allocation of samples, stratified block randomization method will be used. (MACS 1), (MACS 2) and (MACS 3) are considered as randomization layers. In this regard, a random sequence will be created using blocks of 6 (proportion of sample sizes in three groups during the sampling period) and the online program randomization.com. In fact, for each class, there is a specific blocked sequence in which the samples are entered into the desired sequence after evaluation according to the MACS level. To conceal the random sequence, the SNSOE method (Sequentially Numbered, Selected, Opaque Envelops ) will be used, and in the implementation, the person who creates the random sequence process is separate from the person who assigns the participants to the groups, Blinding description: All assessments (primary, secondary, and follow-up) in all three intervention groups (intervention one, intervention two, and control group) will be conducted by an experienced and trained occupational therapist (with at least three years of clinical experience in children) outside the research group and blinded to the allocation of participants to the control and intervention groups (intervention one and two). N/A Condition 1: Cerebral palsy. Condition 2: Spastic diplegic cerebral palsy. Condition 3: Spastic quadriplegic cerebral palsy. Condition 4: Spastic hemiplegic cerebral palsy. Intervention 1: Control group: Conventional occupational therapy treatments (such as a variety of techniques such as Neurodevelopmental treatment, positioning, etc.). Therefore, these children were exposed to a broad range of intervention modalities. Intervention techniques included those aimed at improving impairment (eg, stretching) and enhancing activities (eg, motor learning exercises). In control group, as in the other two groups, the child sets four goals using the Canadian Occupational Performance Measure and work on the set treatment goals continues based on the clinical reasoning of the control group therapist who has no training in Cognitive Orientation to Daily Occupational Performance. The number and duration of conventional occupational therapy sessions in the control group will include at least 2 sessions per week for at least 45 minutes. Treatment in the control group will be provided by occupational therapists with at least two years of clinical experience in the field of children with cerebral palsy and outside the research group and will not be aware of the allocation of samples to the control and intervention groups. Intervention 2: Intervention group: Occupational therapy with Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. According to the established format, (CO-OP) will be conducted in a clinic setting over eleven sessions (one preparatory session followed by ten therapy sessions), twice a week (each session 45 minutes). In the initial introductory session, the therapist will introduce the child to the global problem-solving strategy (goal-plan-do-check), which will be used when working to achieve the goals. Therefore, in the interventions of this group, each child will be taught a Global Cognitive Strategy, and then the therapist will guide to discover Domain Specific Strategies (DSSs) to improve motor-based occupational performance problems. The therapist will guide the child in discovering his/her plan for functioning, and the child will implement this plan and then check whether the action taken is effective or needs to be modified. Intervention will be done on a single goal first (the goal selected by the child as the first priority during the goal-setting phase), and then second and third goals will be gradually added. The interventions in this group will be conducted by an occupational therapist experienced in using CO-OP in the treatment of children with cerebral palsy. Intervention 3: Intervention group: Occupational therapy with an adapted Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. After preparing an adapted version of the (CO-OP) Approach with the addition of self-controlled video feedback, in the preparation session of this group, in addition to explanations about the (CO-OP) approach and the strategies used, necessary training will be provided on how to use self-controlled video feedback. The training provided will be about the importance of benefiting from video feedback and its impact on performance, determining the appropriate time to receive video feedback, how to work with the user interface and manage images, and giving real and practical examples in the form of a case study, and finally the participant will practice how to use it in practice. In the preparation session and before each session, the therapist will remind the participant that at least two or more times should be used self-controlled video feedback and naturally, determining its time, sequence, and number is up to the participant. In fact, participants in this group are able to use elf-controlled video feedback to obtain appropriate cognitive solutions to solve upper limb occupational performance problems. The number of times self-controlled video feedback is received during the sessions will be recorded by the intervention provider. The interventions of this group will be conducted by the main researcher. 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 I have not yet consulted the research team on this issue.
public Amin Rezaei
Tehran, Mirdamad, Madar Square, Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 aminrezaei402@yahoo.com Iran University of Medical Sciences scientific Amin Rezaei
Tehran, Mirdamad, Madar Square, Shah Nazari Street, Madakaran Street, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 aminrezaei402@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of spastic cerebral palsy by a neurologist The age range is between 8 and 11 years level 1-3 of gross motor function based on GMFCS scale level 1-3 of hand function based on MACS scale level of 1-3 of bimanual fine motor function on BFMF scale level of 1-3 of visual function on the VFCS scale level of 1-3 of verbal communication ability using Persian language based on the CFCS scale Placement in the education level according to age or a score higher than 70 based on Sparkle's IQ estimation criteria 8 years 11 years Both History of orthopedic-reconstructive surgeries within the past six months History of botox injection during the last three months Hearing impairments that cannot be corrected with the use of assistive devices. G80 G80.1 G80.0 G80.2 Cerebral palsy Spastic diplegic cerebral palsy Spastic quadriplegic cerebral palsy Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Rehabilitation Control group: Conventional occupational therapy treatments (such as a variety of techniques such as Neurodevelopmental treatment, positioning, etc.). Therefore, these children were exposed to a broad range of intervention modalities. Intervention techniques included those aimed at improving impairment (eg, stretching) and enhancing activities (eg, motor learning exercises). In control group, as in the other two groups, the child sets four goals using the Canadian Occupational Performance Measure and work on the set treatment goals continues based on the clinical reasoning of the control group therapist who has no training in Cognitive Orientation to Daily Occupational Performance. The number and duration of conventional occupational therapy sessions in the control group will include at least 2 sessions per week for at least 45 minutes. Treatment in the control group will be provided by occupational therapists with at least two years of clinical experience in the field of children with cerebral palsy and outside the research group and will not be aware of the allocation of samples to the control and intervention groups. Intervention group: Occupational therapy with Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. According to the established format, (CO-OP) will be conducted in a clinic setting over eleven sessions (one preparatory session followed by ten therapy sessions), twice a week (each session 45 minutes). In the initial introductory session, the therapist will introduce the child to the global problem-solving strategy (goal-plan-do-check), which will be used when working to achieve the goals. Therefore, in the interventions of this group, each child will be taught a Global Cognitive Strategy, and then the therapist will guide to discover Domain Specific Strategies (DSSs) to improve motor-based occupational performance problems. The therapist will guide the child in discovering his/her plan for functioning, and the child will implement this plan and then check whether the action taken is effective or needs to be modified. Intervention will be done on a single goal first (the goal selected by the child as the first priority during the goal-setting phase), and then second and third goals will be gradually added. The interventions in this group will be conducted by an occupational therapist experienced in using CO-OP in the treatment of children with cerebral palsy. Intervention group: Occupational therapy with an adapted Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. After preparing an adapted version of the (CO-OP) Approach with the addition of self-controlled video feedback, in the preparation session of this group, in addition to explanations about the (CO-OP) approach and the strategies used, necessary training will be provided on how to use self-controlled video feedback. The training provided will be about the importance of benefiting from video feedback and its impact on performance, determining the appropriate time to receive video feedback, how to work with the user interface and manage images, and giving real and practical examples in the form of a case study, and finally the participant will practice how to use it in practice. In the preparation session and before each session, the therapist will remind the participant that at least two or more times should be used self-controlled video feedback and naturally, determining its time, sequence, and number is up to the participant. In fact, participants in this group are able to use elf-controlled video feedback to obtain appropriate cognitive solutions to solve upper limb occupational performance problems. The number of times self-controlled video feedback is received during the sessions will be recorded by the intervention provider. The interventions of this group will be conducted by the main researcher. Occupational performance, which is the score that participants report on the performance and satisfaction of their chosen occupations based on a semi-structured interview based on the Canadian Occupational Performance Measure. Timepoint: Occupational performance will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions. Method of measurement: Canadian Occupational Performance Measure. The actual performance of the selected occupations is determined from the score that participants obtain from a video-based observational tool called the Performance Quality Rating Scale (operational definition), which is intended to measure the actual performance of the selected activities of the subjects. Timepoint: The actual performance of the selected occupations will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions. Method of measurement: Performance Quality Rating Scale (Operational Definition). Goal attainment is a method of assessing progress toward individual goals that is used in occupational therapy, physiotherapy, and speech therapy across a wide range of clinical populations, including children, adults, and the elderly. Timepoint: Goal attainment will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions. Method of measurement: Goal Attainment Scaling. Manual ability. Timepoint: Manual ability will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions. Method of measurement: ABILHAND-Kids. Gross manual dexterity. Timepoint: Gross manual dexterity will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions. Method of measurement: Box and Block Test. Pediatric Motivation. Timepoint: To measure changes in motivation during the implementation of interventions, the test was repeated in sequence every three sessions (first, fourth, seventh, and tenth sessions). Method of measurement: Pediatric Motivation Scale. Iran University of Medical Sciences Approved 2024-11-09 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences, 5th floor of the central headquarters, Hemat Highway, next to Milad Tower, Deputy of research and technology Tehran Tehran Iran (Islamic Republic of)