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IRCT20160808029260N4 IRCT 2022-07-15 Iran University of Medical Sciences The effect of action observation training on upper limb function and participation in children with spastic cerebral palsy The effect of meaningful action observation training on upper limb function and participation in 6 to 12-year-old children with spastic cerebral palsy 2022-11-22 anticipated 40 Complete https://irct.ir/trial/62130 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, therapeutic videos are designed according to the principles of a task-oriented approach and the participation of cerebral palsy children similar to the participants, Randomization description: In this research, randomization will be done with the Block method using block sizes of 4 to 6 by Stata software. A statistics expert arranges the assigned order of randomized groups; He, based on this ordering, selects the study groups and puts them in separate envelopes. The envelopes are arranged according to the assigned randomized order achieved by the Block method. A person who is blind to the aims of the study, during examining the inclusion criterion and registering the client information, gives the envelopes to the participants according to the arranged order. When the client enters the occupational therapist's room, the envelope will be opened and the study group will be assigned based on this method, Blinding description: Evaluator: In this study, in order to keep the evaluator blind, an attempt is made to choose the evaluator among experts who are not in the research team and are unaware of the grouping of participants. Participants: In this study, in order to keep the participants blind, the same treatment program is considered for the control and intervention groups, but in the control group, instead of showing therapeutic videos, cartoon pictures and natural scenes are shown. N/A Cerebral palsy. Intervention 1: Intervention group: rehabilitation treatment in this group includes traditional occupational therapy service as well as ''meaningful action observation training''. Each session lasts for 45 minutes and it will be repeated three times a week for one month. The first 15 minutes of each session is devoted to initial preparation techniques for example muscle warming up, stretching, etc. Then, the ''meaningful action observation training'' method is performed. In this method, a film including a performance of a number of predetermined activities is played, and the child is required to watch the model performance in the film carefully. Next, the child should repeat the steps of the performance of the activity as in the model video. Each session, the performance of meaningful action observation training lasts for 15 minutes. Then, the traditional occupational therapy service continues for 15 minutes. These services are selected according to the needs of the participants and include strengthening exercises, balancing, coordination, etc. Intervention 2: Control group: In this group, rehabilitation treatment includes traditional occupational therapy services along with a placebo. Each session lasts for 45 minutes and it will be repeated three times a week for one month. The first 15 minutes of each session, similar to the experimental group, is devoted to initial preparation techniques for example muscle warming up, stretching, etc. Then, the child watches nature scenes and cartoon pictures (as a placebo) and practices predetermined treatment activities continue for 15 minutes. These activities are similar to those of the intervention group and their Placebo videos are similar to treatment videos in the intervention group in terms of length and repetition. The last 15 minutes of each session, are devoted to traditional occupational therapy services. These services are selected according to the needs of the participants from strengthening exercises, balancing, coordination, etc. Yes - There is a plan to make this available What will be shared: demographic data of the study participants after making them unidentifiable; Primary and secondary outcome information When: After publishing the results of the study To whom: Researchers who are working in academic and scientific institutions Conditions: For doing meta-analysis review studies Where to obtain: 1) Samira Boroumand Phone number:0098 9365799466 Email address: Sa.boroumand@yahoo.com Address: School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard, Tehran, Iran 2) Afsoon Hassani Mehraban Phone number: 0098 21 22228051 Email address: mehraban.a@iums.ac.ir Address: School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard, Tehran, Iran How to obtain: The researcher can access the data of this research up to one month after sending the request and attaching the registered protocol of the review article to the introduced emails. Comments:
public Afsoon Hassani Mehraban
School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 mehraban.a@iums.ac.ir Iran University of Medical Sciences scientific Afsoon Hassani Mehraban
School of Rehabilitation, Madadkaran Alley, Shahnazari Street, Madar Square, Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 mehraban.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of spastic cerebral palsy based on a review of the child's medical record 6 to 12 years old Having therapeutic priority, the same as therapeutic videos which are prepared based on the results obtained using the Canadian Occupational Performance Measure (COPM) Getting less than 4 according to Manual Ability Classification System (MACS) 6 years 12 years Both Existence of uncontrolled seizures Existence of other neurological diseases based on the child's medical records Botox injection in the upper limb up to 6 months before attending the research project Existence of cognitive problems according to the SPARCLE classification system Existence of visual and auditory deficits that cannot be compensated by assistive devices Existence of contracture in the upper extremity joints based on the clinical examination of the therapist G80 Cerebral palsy Rehabilitation Rehabilitation Intervention group: rehabilitation treatment in this group includes traditional occupational therapy service as well as ''meaningful action observation training''. Each session lasts for 45 minutes and it will be repeated three times a week for one month. The first 15 minutes of each session is devoted to initial preparation techniques for example muscle warming up, stretching, etc. Then, the ''meaningful action observation training'' method is performed. In this method, a film including a performance of a number of predetermined activities is played, and the child is required to watch the model performance in the film carefully. Next, the child should repeat the steps of the performance of the activity as in the model video. Each session, the performance of meaningful action observation training lasts for 15 minutes. Then, the traditional occupational therapy service continues for 15 minutes. These services are selected according to the needs of the participants and include strengthening exercises, balancing, coordination, etc. Control group: In this group, rehabilitation treatment includes traditional occupational therapy services along with a placebo. Each session lasts for 45 minutes and it will be repeated three times a week for one month. The first 15 minutes of each session, similar to the experimental group, is devoted to initial preparation techniques for example muscle warming up, stretching, etc. Then, the child watches nature scenes and cartoon pictures (as a placebo) and practices predetermined treatment activities continue for 15 minutes. These activities are similar to those of the intervention group and their Placebo videos are similar to treatment videos in the intervention group in terms of length and repetition. The last 15 minutes of each session, are devoted to traditional occupational therapy services. These services are selected according to the needs of the participants from strengthening exercises, balancing, coordination, etc. Upper limb function score. Timepoint: Before and after the intervention. Method of measurement: ABILHAND-kids questionnaire. The score of participation in outside school activities. Timepoint: before and after the intervention. Method of measurement: The Iranian Children's Participation Assessment Scale. Upper limb coordination score. Timepoint: before and after the intervention. Method of measurement: The Bruininks-Oseretsky Test of Motor Proficiency. Upper limb speed and dexterity score. Timepoint: before and after the intervention. Method of measurement: The Bruininks-Oseretsky Test of Motor Proficiency. Gripping power. Timepoint: before and after the intervention. Method of measurement: The Dynamometer. Range of motion. Timepoint: before and after the intervention. Method of measurement: The Goniometer. Occupational performance score. Timepoint: before and after the intervention. Method of measurement: The Canadian Occupational Performance Measure. Iran University of Medical Sciences Approved 2022-03-14 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)