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IRCT20200915048725N2 IRCT 2021-08-01 Iran University of Medical Sciences Comparison of the effect of Hinged AFOs with and without vibration on gait and function in children with spastic hemiplegic cerebral palsy Comparison of the effect of Hinged AFOs with and without vibration on gait and daily function in children with spastic hemiplegic cerebral palsy 2021-07-10 anticipated 24 Complete https://irct.ir/trial/56798 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Spastic hemiplegic cerebral palsy. Intervention 1: The orthosis designed for the intervention group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot. The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet. This orthosis also has a vibrating system. The vibrating system consists of five 5 mm diameter Lee coil vibrators with a frequency of 60 Hz, which are located on the two muscles of gastrocnemius and soleus. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. Vibration control will be via a floor switch so that the vibrators will be turned on by placing the heel on the ground. Due to the accurate recording of the amount of light and the number of times the vibrators are turned on, a data logger will be connected to the system to record the system data based on the duration of use during one month. Intervention 2: Control group: The orthosis designed for this group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot.The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. The orthosis does not have a vibrating system for this group of participants. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data may be available upon reasonable request
public Maryam Jalali
Madadkaran Ave., Shahnazari St., Mirdamad
Tehran Iran (Islamic Republic of) ۱۳۴۸۷ - ۱۵۴۵۹ +98 21 2222 0947 jalali.m@iums.ac.ir Iran University of Medical Sciences scientific Maryam Jalali
Madadkaran Ave., Shahnazari St., Mirdamad
Tehran Iran (Islamic Republic of) ۱۳۴۸۷ - ۱۵۴۵۹ +98 21 2222 7124 jalali.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Children with spastic hemiplegic cerebral palsy aged 4 to 12 years AFO prescribed by a medical specialist or therapist GMFCS level I to III The child is able to stand independently At least 2 weeks have passed since the previous lower limb orthosis was received At least six months have passed since the last Botox injection in the lower extremities spasticity grade based on Ashworth scale (2 and 3) 4 years 12 years Both Any injuries or wounds at the orthosis site G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation The orthosis designed for the intervention group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot. The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet. This orthosis also has a vibrating system. The vibrating system consists of five 5 mm diameter Lee coil vibrators with a frequency of 60 Hz, which are located on the two muscles of gastrocnemius and soleus. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. Vibration control will be via a floor switch so that the vibrators will be turned on by placing the heel on the ground. Due to the accurate recording of the amount of light and the number of times the vibrators are turned on, a data logger will be connected to the system to record the system data based on the duration of use during one month. Control group: The orthosis designed for this group is a hinged AFO. Based on the ability of each participant to control the knee joint, range of motion of the ankle joint in the direction of dorsiflexion will be adjusted. In fact, participants with a higher level of knee control will be able to more range of motion of dorsiflexion, and accordingly, participants who have less knee control will be able to less range of motion of the ankle . The joints are made of stainless steel with a weight of 100 grams. A joint pair will be used for each orthosis. Also, the body of the orthosis is made of polypropylene sheet with a thickness of four mm, which will be shaped based on the shape of each participant's foot.The orthosis trim line is from lower than head of fibula bony to the fingertips. It will then be connected to the participants' feet via four straps. A strap is located at the leg below the knee. One strap above the ankle and one strap below the ankle and the last strap will be on the toes. The duration of treatment is one month. Participants wear orthoses for at least 8 hours each day. The orthosis does not have a vibrating system for this group of participants. The total weight of the orthosis will be between 300 and 500 grams depending on the size of the participants' feet. Ankle joint kinematic. Timepoint: Before the intervention and one month after. Method of measurement: Three-dimensional motion analysis. Knee joint kinematic. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis. Hip joint kinematic. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis. Stride length. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis. Step width. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Three-dimensional motion analysis. Function. Timepoint: Before the intervention and one month after the intervention and two weeks after weaning of the orthosis. Method of measurement: PEDI questionnaire. ُSpeed of walking. Timepoint: Before the intervention and one month after the intervention. Method of measurement: 120 / step length × cadence. Cadence. Timepoint: Before the intervention and one month after the intervention. Method of measurement: Number of steps per second. Duration of a complete walking cycle. Timepoint: Before the intervention and one month after the intervention. Method of measurement: According to each participant's gait pattern, the initial contact is detected based on kinematic data and the time interval between two successive initial contacts will be measured. Spasticity of the gastrosoleus muscles. Timepoint: Before the intervention and one month after the intervention and two weeks after weaning the orthosis. Method of measurement: Ashworth Scale. Satisfaction. Timepoint: Before the intervention and one month after the intervention. Method of measurement: OPUS Satisfaction Questionnaire. Iran University of Medical Sciences Approved 2021-05-16 Ethics committee of Iran University of Medicine Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)