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IRCT20210629051738N1 IRCT 2021-09-10 University of social welfare and rehabilitation sciences The effect of “swallowing therapy with action observation treatment” protocol Developing a protocol of “swallowing therapy with action observation treatment” and investigating its effectiveness on swallowing and feeding in 3 to 12 years old children with spastic cerebral palsy 2021-11-10 anticipated 20 Complete https://irct.ir/trial/58153 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be assigned to one of the two experimental and control groups using blocked randomization method with randomly selected block sizes of 4 and 6. Randomization will be done by an independent researcher from a different research center using an internet softwires so the participants and the assessor will be concealed for assignment, Blinding description: Participants will not know if they are in the experimental or control groups. As this a parental based program so participants do not need to come to clinic a lot and they are connected to therapists during the mostly through internet during the intervention and kept separated from each other. The evaluator is also different from the therapist and will not be given information about interventions and the individuals` assignment. 2-3 Condition 1: cerebral palsy. Condition 2: dysphagia. Intervention 1: Intervention group: Intervention includes action observation treatment (AOT) and functional oral sensorimotor therapy (F-OST). First each target movements performing by a healthy child in a video will be observed by the participant as (AOT) and then will be practiced as F-OST. Intervention will last for 10 weeks, 5 days a week, 2 times a day and 20 minutes each time. Intervention 2: Control group: Like the intervention group, the intervention includes functional oral sensorineural therapy (F-OST), but instead of AOT, a placebo will be used, i.e. the person will spend the same time watching the video, but the videos are not related to the target movements. The treatment will last for 10 weeks, 5 days a week, 2 times a day for 20 minutes each time. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcome measures are to be shared. When: 6 months after publication To whom: It's only available for people working in academic institutions. Conditions: Requests for sharing data should be sent to the person responsible for general inquiries. Where to obtain: Requests for sharing data should be sent to the person responsible for scientific inquiries. Maryam Mokhlesin m_mokhlessin@yahoo.com How to obtain: Data will be shared after receiving requests by email in less than 1 month. Comments:
public Maryam Mokhlesin
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 m_mokhlessin@yahoo.com Semnan University of Medical Sciences scientific Maryam Mokhlesin
Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd
Semnan Iran (Islamic Republic of) 3514799442 +98 23 3344 1022 m_mokhlessin@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Spastic cerebral palsy 3-12 years old Having problem in oral phase of dysphagia Literate caregiver Having access to internet and smart phone or computer 3 years 12 years Both progressive neurological disease severe visual problems severe hearing problems intellectual disorder orofacial syndromes uncontrol seizure Tube feeding G80 R13.1 Cerebral palsy Dysphagia Rehabilitation Rehabilitation Intervention group: Intervention includes action observation treatment (AOT) and functional oral sensorimotor therapy (F-OST). First each target movements performing by a healthy child in a video will be observed by the participant as (AOT) and then will be practiced as F-OST. Intervention will last for 10 weeks, 5 days a week, 2 times a day and 20 minutes each time. Control group: Like the intervention group, the intervention includes functional oral sensorineural therapy (F-OST), but instead of AOT, a placebo will be used, i.e. the person will spend the same time watching the video, but the videos are not related to the target movements. The treatment will last for 10 weeks, 5 days a week, 2 times a day for 20 minutes each time. Swallowing function. Timepoint: Pre and post intervention, 1 and 3 months after the intervention as follow up asessment. Method of measurement: Oral Motor Assessment Scale (OMAS), Schedule Oral Motor Assessment (SOMA), Dysphagia Disorder Survey (DDS). Feeding performance. Timepoint: Before and after therapy, 1 and 3 months after the intervention as follow up assessment. Method of measurement: Pedi-Eat scale. Caregivers` quality of life. Timepoint: Before and after therapy, 1 and 3 months after the intervention as follow up assessment. Method of measurement: Feeding swallowing impact survey. University of social welfare and rehabilitation sciences Approved 2021-08-25 Ethics committee of University of Social Welfare and Rehabilitation Sciences Kodakyar Ave., Daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)