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IRCT20171219037953N2 IRCT 2023-10-18 Iran University of Medical Sciences VWM-B program and executive functions in Dyslexia VWM-B Investigating the effectiveness of the Verbal Working Memory-Balance (VWM-B) robotic training program on executive functions in children with developmental dyslexia 2023-04-03 anticipated 30 Complete https://irct.ir/trial/70215 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: As mentioned, participants may become aware of the differences in training types through their parents or other means, making this a quasi-double-blinding study, Randomization description: Using Excel software, we employed a block randomization method that divided our participants (N=30) into two equal groups. In Excel, the entire participants are encoded in a column with numbers from 1 to 30. At first, participants' names are written on separate pieces of paper. These papers are then seal, place in a bag, and randomly draw to assign each person a number from 1 to 30. Next to this column, another column is made. The participants are divided into five blocks of six people, and each block is assigned a number. From top to down, the first six people are numbered by block 1. The second six people are numbered by block 2 and so forth the last six people are numbered by block 5. Using the Randbetween function in Excel, three participants from each block randomly assign to the control group and the remaining three to the experiment group. This lottery process repeats for all five blocks, resulting in 15 participants in each group, Blinding description: In this study, all participants and an assessor who is not part of the research group will be blinded. Parents will be informed, but participants will not know which group they have been assigned to (the experiment group will receive verbal working memory-balance program training, while the control group will receive verbal working memory program training). Data will be collected before and after the treatment by a blinded assessor who will not know which group each participant belongs to. However, participants may become aware of the differences in training types through their parents or other means, making this a quasi-double-blinding study. This quasi-double-blinding approach is consistent with two previously reports that used the same training programs and the same grouping. Ramezani M, Behzadipour S, Fawcett AJ, Joghataei MT. Verbal Working Memory‐Balance program training alters the left fusiform gyrus resting‐state functional connectivity: A randomized clinical trial study on children with dyslexia. Dyslexia. 2023 Jun 19. Ramezani M, Behzadipour S, Pourghayoomi E, Joghataei MT, Shirazi E, Fawcett AJ. Evaluating a new verbal working memory-balance program: a double-blind, randomized controlled trial study on Iranian children with dyslexia. BMC neuroscience. 2021 Dec;22:1-7. N/A ِDevelopmental Dyslexia. Intervention 1: Experiment group: The newly designed VWM-B program has been performed using the robotic device. Like the VWM program, each training trial in the VWM-B program includes all three sub-processes of working memory (WM). The difference is that balance movements have been combined with the maintenance and retrieval steps of WM. Participants’ standing condition was controlled for uniformity among subjects. The feet position on the platform was the same for all participants, with an approximate distance of 10 cm between the feet. Also, the monitor was located at eye level, with a distance of approximately 50 cm. For the encoding step, similar to the VWM program, a trial began 3 s after touching the start button on the monitor, and the main target box appeared on the monitor for 10 s. Then, the component boxes appeared on the screen. In addition to the component boxes, a red circle (CoP marker) also appeared on the screen. This circle represented the position of the subject’s center of pressure and was used to introduce balance tasks to the program. As a new method, training the maintenance and manipulation of information was performed in two forms: passive and active balance. In the passive state, the motorized moving platform underneath the subject’s feet was tilted and the CoP marker was correspondingly moved toward the component boxes implying a passive exercise. After the component box was hit by the CoP marker, the participant had 10 s to recite the word inside the box. Then, the platform and the CoP marker returned to the start position. This procedure was repeated for all component boxes in the correct order. In the active state, the platform had no tilting motion, and the subject had to actively move his CoP toward the component boxes using ankle/hip strategies. After hitting each component box, the participant attempted to read the word aloud without time limitation. Following reading the word, he returned to the start position and repeated the procedure for all component boxes. For the retrieval step in the VWM program, the target is shown and the user should accept or reject recalling the target. However, in the VWM-B program’s retrieval step, the subject has to move his CoP to select the target. These texts are referenced by: Ramezani M, Behzadipour S, Pourghayoomi E, Joghataei MT, Shirazi E, Fawcett AJ. Evaluating a new verbal working memory-balance program: a double-blind, randomized controlled trial study on Iranian children with dyslexia. BMC Neurosci. 2021 Sep 15;22(1):55. doi 10.1186/s12868-021-00660-1. PMID: 34525977; PMCID: PMC8442443. Intervention 2: Control group: While training with the VWM program, the subject sat on a chair in a relaxed mood with arms resting on the table. A 19-inch touchscreen monitor ran the software, which was specially designed for the proposed training program, and a speaker was used to recite the words. As mentioned above, each training trial of the VWM program includes all three sub-processes (encoding, maintenance, and retrieval steps) of the working memory (WM). Each trial began 3 seconds after touching the start button on the monitor. For the encoding step, the target, which could be a word, a series of words, or a statement, written inside a box (target box), was shown on the monitor for 10 s. At the same time, the target was recited by playing a pre-recorded voice on the computer. For the maintenance step, the target was decomposed into its components (sentence to its words or word to its letters) and shown on the monitor inside separate boxes (component boxes) for 10 s. Finally, for the retrieval step, twice as many boxes, which included the practiced components and new ones appeared on the monitor. The participant had 10 s to select and touch the boxes, which had appeared and been recited as a component of the target. These texts are referenced by: Ramezani M, Behzadipour S, Pourghayoomi E, Joghataei MT, Shirazi E, Fawcett AJ. Evaluating a new verbal working memory-balance program: a double-blind, randomized controlled trial study on Iranian children with dyslexia. BMC Neurosci. 2021 Sep 15;22(1):55. doi 10.1186/s12868-021-00660-1. PMID: 34525977; PMCID: PMC8442443. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mehdi Ramezani
Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 ergotherapist.ramezani@gmail.com Iran University of Medical Sciences scientific Mehdi Ramezani
Hemmat Highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 86701 ergotherapist.ramezani@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Normal IQ level Normal attention level Normal or corrected vision/hearing conditions Right-handedness using the short form of Edinburgh handedness inventory Native-Persian language Average socio-economic status as reported by the family 8 years 10 years Both History of taking drugs affecting the central nervous system History of neurological or psychiatric disorders Not partaking in after-treatment assessments Failing to complete a minimum of 75% of the training sessions (being absent in more than 4 out of 15 sessions) R48.0 Dyslexia and alexia Treatment - Devices Treatment - Devices Experiment group: The newly designed VWM-B program has been performed using the robotic device. Like the VWM program, each training trial in the VWM-B program includes all three sub-processes of working memory (WM). The difference is that balance movements have been combined with the maintenance and retrieval steps of WM. Participants’ standing condition was controlled for uniformity among subjects. The feet position on the platform was the same for all participants, with an approximate distance of 10 cm between the feet. Also, the monitor was located at eye level, with a distance of approximately 50 cm. For the encoding step, similar to the VWM program, a trial began 3 s after touching the start button on the monitor, and the main target box appeared on the monitor for 10 s. Then, the component boxes appeared on the screen. In addition to the component boxes, a red circle (CoP marker) also appeared on the screen. This circle represented the position of the subject’s center of pressure and was used to introduce balance tasks to the program. As a new method, training the maintenance and manipulation of information was performed in two forms: passive and active balance. In the passive state, the motorized moving platform underneath the subject’s feet was tilted and the CoP marker was correspondingly moved toward the component boxes implying a passive exercise. After the component box was hit by the CoP marker, the participant had 10 s to recite the word inside the box. Then, the platform and the CoP marker returned to the start position. This procedure was repeated for all component boxes in the correct order. In the active state, the platform had no tilting motion, and the subject had to actively move his CoP toward the component boxes using ankle/hip strategies. After hitting each component box, the participant attempted to read the word aloud without time limitation. Following reading the word, he returned to the start position and repeated the procedure for all component boxes. For the retrieval step in the VWM program, the target is shown and the user should accept or reject recalling the target. However, in the VWM-B program’s retrieval step, the subject has to move his CoP to select the target. These texts are referenced by: Ramezani M, Behzadipour S, Pourghayoomi E, Joghataei MT, Shirazi E, Fawcett AJ. Evaluating a new verbal working memory-balance program: a double-blind, randomized controlled trial study on Iranian children with dyslexia. BMC Neurosci. 2021 Sep 15;22(1):55. doi 10.1186/s12868-021-00660-1. PMID: 34525977; PMCID: PMC8442443. Control group: While training with the VWM program, the subject sat on a chair in a relaxed mood with arms resting on the table. A 19-inch touchscreen monitor ran the software, which was specially designed for the proposed training program, and a speaker was used to recite the words. As mentioned above, each training trial of the VWM program includes all three sub-processes (encoding, maintenance, and retrieval steps) of the working memory (WM). Each trial began 3 seconds after touching the start button on the monitor. For the encoding step, the target, which could be a word, a series of words, or a statement, written inside a box (target box), was shown on the monitor for 10 s. At the same time, the target was recited by playing a pre-recorded voice on the computer. For the maintenance step, the target was decomposed into its components (sentence to its words or word to its letters) and shown on the monitor inside separate boxes (component boxes) for 10 s. Finally, for the retrieval step, twice as many boxes, which included the practiced components and new ones appeared on the monitor. The participant had 10 s to select and touch the boxes, which had appeared and been recited as a component of the target. These texts are referenced by: Ramezani M, Behzadipour S, Pourghayoomi E, Joghataei MT, Shirazi E, Fawcett AJ. Evaluating a new verbal working memory-balance program: a double-blind, randomized controlled trial study on Iranian children with dyslexia. BMC Neurosci. 2021 Sep 15;22(1):55. doi 10.1186/s12868-021-00660-1. PMID: 34525977; PMCID: PMC8442443. Executive functions including verbal semantic and phonemic fluency, trail making, response inhibition, verbal working memory, and text comprehension. Timepoint: Before and after the intervention. Method of measurement: Questionnaires. Reading skills. Timepoint: Before and after the intervention. Method of measurement: Questionnaires. Iran University of Medical Sciences Approved 2023-02-22 Ethics Committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)