]>
IRCT20230219057447N1 IRCT 2023-05-25 Tehran University of Medical Sciences The Effect of Computer Vision Games on Handwriting, Visual Perception and Visual Motor Integrity Effect of Computerized Visual Games on Handwriting, Visual Perception and Visual Motor Integration in the Children with Spastic Cerebral Palsy in the second and third grades of elementary schools. 2024-12-21 anticipated 30 Complete https://irct.ir/trial/69244 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A stratified permuted block randomization method will be used in this trial. Participants will first be stratified based on the type of spastic cerebral palsy into three strata: hemiplegia, diplegia, and quadriplegia. Within each stratum, participants will be randomly assigned to one of the three study groups: Group A (visual-motor integration intervention), Group B (visual perception intervention), and Group C (control group). Thus, randomization will be performed separately within each CP subtype to ensure balance across groups. To achieve allocation concealment, we will use sealed, opaque envelopes made with foil and carbon paper to prevent any visibility of group assignment. Since we are not certain about the exact number of participants in each CP subtype in advance, and to follow recommendations from similar studies (e.g., Doig et al., 2005), we will prepare more than the planned 30 envelopes specifically, 81 envelopes in total, consisting of 27 for each group (A, B, and C). These envelopes will be distributed across three Tupperware-style containers, each labeled according to the CP subtype (hemiplegia, diplegia, quadriplegia). In each container, 9 envelopes from each group (A, B, and C) will be placed (totaling 27 envelopes per stratum). These envelopes will not be mixed between strata. Within each stratum, random blocks of size 3 and 6 will be created, and envelopes will be shuffled within each block. To determine the sequence of blocks, a coin-flipping method will be used: if the coin lands on heads, a block of size 3 will be selected; if tails, a block of size 6. This process will be repeated until a complete block sequence is generated for each stratum. Once the block order is finalized, it will remain fixed. Subsequently, envelopes within each stratum will be numbered sequentially: H1–H27 for hemiplegia, D1–D27 for diplegia, and Q1–Q27 for quadriplegia. As each participant enters the trial, after being classified by CP subtype, the next available envelope in that stratum will be assigned to them in sequence. Importantly, this entire randomization and allocation process will be performed by an independent researcher who is not involved in recruitment, intervention delivery, or outcome assessments, in order to minimize potential bias 54, Blinding description: Given that all relevant information is included in the informed consent form, participants in this study will be fully aware of the group to which they are assigned after allocation. Specifically, participants in the intervention groups will receive computerized games, whereas participants in the control group will not receive any intervention from the therapist during the study. Therefore, blinding of participants is not possible. In this study, only the data analysts will be blinded to allow for a single-blind design. The principal investigator will conduct both the baseline assessments and the interventions, as well as the post-intervention evaluations, and will be fully aware of the entire study process. 3 Cerebral palsy. Intervention 1: First intervention group: This group, consisting of 10 children, will receive a computerized visual perception game intervention for 20 sessions. The visual perception games target skills related to visual processing and progress from easy to difficult levels. The games consist of a series of cards adapted from exercise books and designed as games. These cards were suggested by occupational therapists, optometrists, educators, learning specialists, and other health professionals, and aim to train skills such as figure-ground discrimination, visual discrimination, visual form constancy, visual closure, visual sequential memory, visuospatial relations, and visual memory in children who need improvement in these areas. In each session, a specific number of exercises will be assigned to the child, who will play the games on the researcher’s computer and receive guidance from the therapist if errors occur. Each session will last 45 minutes, with two sessions per week, totaling 20 sessions over 10 weeks. In addition to this intervention, traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) will be provided to these children by occupational therapists from the same schools and clinics. Intervention 2: Second intervention group: This group, consisting of 10 children with cerebral palsy, will receive a computerized visual-motor integration game intervention for 20 sessions. The games are designed based on the German software CogPack and include nine different modules aimed at training visual-motor integration skills. The names of these games are: Visual-Motor, Flying Saucers, Ball, Falling Stars, Maze, Board and Cake Division, Navigation, and Mirror, each with multiple difficulty levels. A specific number of these modules will be completed in each session. Each session will last 45 minutes, conducted on the researcher’s computer by the child, with two sessions per week over a total of 10 weeks. In addition to this intervention, traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) will be provided to these children by occupational therapists from the same schools and clinics. Intervention 3: Control group: This group, consisting of 10 children with cerebral palsy, will not receive any intervention from the researcher during the study. They will only participate in traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) provided by occupational therapists from the same schools and clinics. Yes - There is a plan to make this available What will be shared: Data related to the variables will be made available to the Occupational Therapy Education Research Department and, upon request by the corresponding author, will be provided to them for use in meta-analysis studies. When: The first part, concerning the provision of data to the Occupational Therapy Education group, will be carried out after the article is published. For the second part, data will be sent whenever an official request is received from the authors of meta-analysis studies. To whom: For researchers working in academic and scientific institutions Conditions: For further studies in this field, based on the recommendations provided in the article. Where to obtain: corresponding author (Dr. Hamid Dalvand) How to obtain: First, a message regarding the purpose of data usage, along with sufficient information about the researcher’s name and contact details, will be emailed to the researcher. If the details are reviewed and the procedures are verified, it will be sent within a short period of time. Comments:
public Aida Kazemnazhand Asl
Girls' Dormitory of Tehran University of Medical Sciences, North Kargar Ave, Amir Abad, Tehran
Tehran Iran (Islamic Republic of) 5539955975 +98 21 8670 5503 a-kazemnazhand@razi.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Hamid Dalvand
Tehran, Pich-e Shomiran, School of Rehabilitation, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) 1439955975 +98 21 8670 5503 hamiddalvand@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Children with cerebral palsy participating, second and third grade of primary school Children diagnosed with spastic cerebral palsy by pediatric neuroscience specialty Children in the gross movement classification system (GMFCS E&R) at levels I, II, III Children in manual abilities classification system (MACS) at levels I, II, III Children have the ability to write with pencil Children with cognitive scores above 70 Children who do not achieve complete scores according to legibility criteria according to Persian Handwriting Test (PHAT) Children who have difficulty in the Visual Perception Skills Test (TVPS-R), i.e. obtain scores below the defined average Children who do not achieve complete scores by age in the Visual-Motor Integrity Test (DTVMI) 8 years no limit Both Children with modified visual acuity with glasses less than 0.8 in close vision Children with obvious eye deviation (strabismus) Children with any kind of orthopedic anomalies, upper extremity surgeries in the last six months or botulinum injections in the last three months G80 Cerebral palsy Rehabilitation Rehabilitation Rehabilitation First intervention group: This group, consisting of 10 children, will receive a computerized visual perception game intervention for 20 sessions. The visual perception games target skills related to visual processing and progress from easy to difficult levels. The games consist of a series of cards adapted from exercise books and designed as games. These cards were suggested by occupational therapists, optometrists, educators, learning specialists, and other health professionals, and aim to train skills such as figure-ground discrimination, visual discrimination, visual form constancy, visual closure, visual sequential memory, visuospatial relations, and visual memory in children who need improvement in these areas. In each session, a specific number of exercises will be assigned to the child, who will play the games on the researcher’s computer and receive guidance from the therapist if errors occur. Each session will last 45 minutes, with two sessions per week, totaling 20 sessions over 10 weeks. In addition to this intervention, traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) will be provided to these children by occupational therapists from the same schools and clinics. Second intervention group: This group, consisting of 10 children with cerebral palsy, will receive a computerized visual-motor integration game intervention for 20 sessions. The games are designed based on the German software CogPack and include nine different modules aimed at training visual-motor integration skills. The names of these games are: Visual-Motor, Flying Saucers, Ball, Falling Stars, Maze, Board and Cake Division, Navigation, and Mirror, each with multiple difficulty levels. A specific number of these modules will be completed in each session. Each session will last 45 minutes, conducted on the researcher’s computer by the child, with two sessions per week over a total of 10 weeks. In addition to this intervention, traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) will be provided to these children by occupational therapists from the same schools and clinics. Control group: This group, consisting of 10 children with cerebral palsy, will not receive any intervention from the researcher during the study. They will only participate in traditional handwriting exercises (including sensory-motor activities and paper-and-pencil tasks) provided by occupational therapists from the same schools and clinics. Handwriting. Timepoint: Before the study and after the end of the study (the interval between pre-test and post-test will be 10 weeks). Method of measurement: Persian Handwriting Assessment Tool (PHAT). Visual-motor integrity. Timepoint: Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test). Method of measurement: the Beery Bactenica visual Motor Integrity Development Test. Visual percetion. Timepoint: Before the start of the intervention and after the end of the intervention (10 weeks gap between pre-test and post-test). Method of measurement: Visual Perception Skills Test TVPS-R. Cognitive Ability. Timepoint: At the time of determining the entry criteria (before the beginning of the intervention). Method of measurement: With Sparkle Form. Gross Motor Function. Timepoint: At the time of determining the entry criteria (before the beginning of the intervention). Method of measurement: Gross Movement Classification System GMFCS. Ability of the hand. Timepoint: At the time of determining the entry criteria (before the beginning of the intervention). Method of measurement: Manual Ability Classification System MACS. Visual acuity. Timepoint: At the time of determining the entry criteria (before the beginning of the intervention). Method of measurement: With the Snellen Vision Chart. Tehran University of Medical Sciences Approved 2023-04-30 Ethics Committee of Tehran University of Medical Sciences Tehran Medical Sciences Girls' Dormitory, north kargar. amir abad. tehran Tehran Tehran Iran (Islamic Republic of)