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IRCT20220627055296N1 IRCT 2022-09-18 University of social welfare and rehabilitation sciences Effect of virtual reality on hand function and activity performance of children with spastic hemiplegia Effect of task oriented virtual reality on hand function and activity performance of children with spastic hemiplegia 2022-09-21 anticipated 30 Complete https://irct.ir/trial/65379 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning random to the two groups is the four blocks. Random numbers are generated so that even numbers are related to the control group, and odd numbers are related to the intervention group. Each number is placed in an envelope and a number is given to it. Then, each newly arrived child is assigned an envelope whose number is matched with the child's number (numbered in order of arrival), and his/her group is determined. Therefore, the opinion of the researcher and assessor will not be considered in the allocation of children, Blinding description: Researcher,Assessor According to blocks of four, random numbers are generated in such a way that even numbers correspond to the control group and odd numbers correspond to the intervention group, and each number is placed in an envelope and given a number. Then, each child who has just entered the study is assigned an envelope whose number matches the child's number (they are numbered in the order of entry) and his group is determined. Therefore, the opinion of the researcher and evaluator will not be considered in the allocation of children. N/A Hemiplegia cerebral palsy. Intervention 1: Intervention group: cerebral palsy hemyplegia age 6 -10 so these children receive common occupational therapy treatments, the intervention of virtual reality for 6 weeks. After six weeks, measurements are made again in both groups. The treatment in both groups is Each session lasts 45 minutes, twice a week, for 6 consecutive weeks. People in the intervention group receive the upper limb virtual reality program for 15 minutes in addition to neurodevelopmental therapy in each session. The virtual reality program includes picking up a glass and reaching it to the mouth, picking up a knife and cutting, picking up a spoon and filling it, and Finally, take it to the mouth. Based on Leap Motion, hand movements are read and the child sees the means of doing the activity (spoon, glass, etc.) on the opposite screen and the movements are displayed virtually. Intervention 2: Control group: In the control group, common occupational therapy treatments such as neurodevelopmental therapy are implemented. The treatment in this group takes place for 45 minutes in each session, twice a week, for 6 consecutive weeks. After the completion of six weeks, the measurements are performed again. The neurodevelopmental program is used for both groups according to the individual needs of the children and includes the regulation of muscle tone during activities, facilitation of normal movements for upper limb activities, training Upper extremity functional skills, activities of daily living such as eating, drinking, holding various objects are done with emphasis on practicing functional tasks as much as possible and fine motor activities. Yes - There is a plan to make this available What will be shared: only part of the data such as information related to the main outcome can be shared When: The access period starts 6 months after the results are published To whom: cerebral palsy children and their parents, re searchers,people who work in medical field Conditions: for scientific and medical purposes Where to obtain: fateme salehi fateme.salehi.817@gmail.com Dr saeid fatorehchy saeidfatorehchy@yahoo.com How to obtain: after the official release of the data Comments:
public fateme salehi nasab
Marzdaran
Tehran Iran (Islamic Republic of) 1461712345 +98 66 3340 7776 fateme.salehi.817@gmail.com University of social welfare and rehabilitation sciences scientific fateme salehi nasab
Marzdaran
Tehran Iran (Islamic Republic of) 1461712345 +98 66 3340 7776 fateme.salehi.817@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Parents consent for children's participation in the study (completing the consent form) Age range from 6 to 10 years No use of Virtual reality approaches before intervention Located in level 1 or 2 manual ability classification system Located in level 1 to 3 of the gross motor function classification system (for proper trunk control) No history of Botox injections, surgery or fractures during at least 6 months before the intervention Grade 2 or less spastic tone based on Ashworth modified scale in all upper extremity joints involved Studying in primary schools, normal or physically motor schools. No obvious and tangible deformity in the upper extremity Absence of obvious and noticeable deformity in the involved upper limb No severe vision problems or blindness of the child 6 years 10 years Both The presence of other neurological, orthopedic and psychological diseases in the child based on the medical record G80.2 Spastic hemiplegic cerebral palsy Treatment - Other Treatment - Devices Intervention group: cerebral palsy hemyplegia age 6 -10 so these children receive common occupational therapy treatments, the intervention of virtual reality for 6 weeks. After six weeks, measurements are made again in both groups. The treatment in both groups is Each session lasts 45 minutes, twice a week, for 6 consecutive weeks. People in the intervention group receive the upper limb virtual reality program for 15 minutes in addition to neurodevelopmental therapy in each session. The virtual reality program includes picking up a glass and reaching it to the mouth, picking up a knife and cutting, picking up a spoon and filling it, and Finally, take it to the mouth. Based on Leap Motion, hand movements are read and the child sees the means of doing the activity (spoon, glass, etc.) on the opposite screen and the movements are displayed virtually Control group: In the control group, common occupational therapy treatments such as neurodevelopmental therapy are implemented. The treatment in this group takes place for 45 minutes in each session, twice a week, for 6 consecutive weeks. After the completion of six weeks, the measurements are performed again. The neurodevelopmental program is used for both groups according to the individual needs of the children and includes the regulation of muscle tone during activities, facilitation of normal movements for upper limb activities, training Upper extremity functional skills, activities of daily living such as eating, drinking, holding various objects are done with emphasis on practicing functional tasks as much as possible and fine motor activities. Hand performance based on the duration obtained from the Jebsen-Taylor test. Timepoint: start of study ,after 6 weeks. Method of measurement: Jebsen Taylor hand function test. Motor control of upper extremity. Timepoint: start of the study, after 6 weeks. Method of measurement: Performance based upper extremity motor control test. Active range of motion of carpo meta carpal. Timepoint: start of the study, after 6 weeks. Method of measurement: Leap motion. Active range of motion of the fingers. Timepoint: start of the study, after 6 weeks. Method of measurement: Leap motion. Grip strength. Timepoint: start of the study, after 6 weeks. Method of measurement: Jamar dynamometer. University of social welfare and rehabilitation sciences Approved 2022-08-20 Ethics committee of university of social welfare and rehabilitation sciences Velenjak, Koodakyar Tehran Tehran Iran (Islamic Republic of)