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IRCT20211106052977N1 IRCT 2022-08-12 Shahid Beheshti University of Medical Sciences The effect of mirror therapy on the lower extremities of children with Hemiplegic cerebral palsy The efficacy of mirror therapy on lower limb motor function in children with Hemiplegic cerebral palsy 5 to 12 years 2021-05-10 anticipated 24 Complete https://irct.ir/trial/65155 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By simple random sampling using lottery (random allocation law) and without placement (according to the number of people in both groups, the two letters A and B, where the letter A represents the control group and the letter B represents the treatment group, on paper In the next step, the papers are poured into the bag, then the papers are randomly removed from the bag without replacement and the sequence created is recorded.) The children are divided into a control group and a treatment group, Blinding description: In this research, participants are unaware that they are in the control or treatment group because the treatment group receives mirror therapy and the control group receives sham therapy. The evaluator is also unaware of the assignment of individuals to the control and treatment group. In addition, the data analyzer is unaware of assigning individuals to the control and treatment groups because they are defined as groups A and B. N/A cerebral palsy. Intervention 1: Intervention group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the healthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees. Intervention 2: Control group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the unhealthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees. Yes - There is a plan to make this available What will be shared: Data related to the main outcomes and demographic factors can be shared after the individuals are not identified. When: It is possible to start the data access period after 6 months from the printing of the results. To whom: Research-related data is only available upon request to researchers affiliated with academic institutions. Conditions: Research-related data and documentation can only be used if used in conjunction with related research. Where to obtain: To receive the documents, researchers can apply by sending a message with sufficient explanations to j.alipour76@gmail.com to receive the documents and data. How to obtain: After sending the message to the mentioned email, the researchers will be notified of the result of the request after one to two weeks. Comments:
public Reihaneh Askary Kachoosangy
Imam Hussein Hospital, Madani St, Tehran
Tehran Iran (Islamic Republic of) 1617763141 00982173430 re-askary@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Javad Alipour
No. 26, shiraz Street, west zayandeh rood Avenue, vanak sq, Tehran, Iran
Tehran Iran (Islamic Republic of) 1991613651 +98 21 8803 2381 j.alipour76@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The child should be between 5 and 12 years old. The child should be diagnosed with spastic hemiplegia according to a pediatric neurologist. The child must be able to walk independently at least 10 meters. The child's muscle tone should be less than 3 on the MODIFIED ASHWORTH scale. The child must be able to follow verbal instructions. The child should be at levels one and two according to the GMFCS scale in terms of gross motor function. 5 years 12 years Both The child has uncontrolled seizures. The child has a cognitive disability according to medical history. The child has a problem with hemianopia and unilateral neglect. The child has other neurological diseases. The child has had orthopedic surgery on the lower limb according to medical history. The child has a fixed limit on range of motion in the lower limb joints. According to medical history, the child has Auditory acuity problems that have not been corrected or treated. According to medical history, the child has Visual acuity problems that have not been corrected or treated. The child had a Botox injection in the lower limb for up to 6 months before the intervention. Rehabilitation Placebo Intervention group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the healthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees. Control group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the unhealthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees. Dynamic balance score in the timed up and go test. Timepoint: Determining the dynamic balance score before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: Timed Up and Go Test. Static balance score in the pediatric balance scale. Timepoint: Determining the static balance score before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: pediatric balance scale. Step length obtained by analyzing data of gait analysis system. Timepoint: Determining the length of the step before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: gait analysis system. Stride length obtained by analyzing data of gait analysis system. Timepoint: Determining the length of the stride before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: gait analysis system. Stance phase time obtained by analyzing data of gait analysis system. Timepoint: Determining the stance phase time before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: gait analysis system. Swing phase time obtained by analyzing data of gait analysis system. Timepoint: Determining the swing phase time before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: gait analysis system. Spasticity score calculated using the modified Ashworth scale. Timepoint: Determination of spasticity before the intervention, at the end of the intervention period and one month after the intervention. Method of measurement: modified Ashworth scale. Shahid Beheshti University of Medical Sciences Approved 2021-03-09 Ethics committee of Shahid Beheshti University of Medical Sciences No 26, shiraz Street, west zayandeh rood Avenue, vanak square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)