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IRCT20250202064598N1 IRCT 2025-03-17 Esfahan University of Medical Sciences The effects of optimizing ankle-foot orthosis footwear combinations on the kinematics of children with cerebral palsy The effects of biomechanically optimized ankle foot orthosis footwear combinations on the trunk and upper limb kinematics in children with cerebral palsy while walking 2025-04-21 anticipated 10 Complete https://irct.ir/trial/81930 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: The study includes an intervention group of children with cerebral palsy, all of whom receive interventions and the immediate effects of each intervention on kinematic data are analyzed. Additionally, a healthy control group is included, which does not receive any interventions; only their normal kinematic data are recorded. N/A cerebral palsy. Intervention 1: Intervention group: The conventional foot and ankle orthosis is made for each patient using a 5 mm thick polypropylene sheet after taking a mold and modifying the mold. In this orthosis, the ankle will be at 90 degrees. The orthosis extends from the tips of the toes to below the knee. The orthosis incision line in the ankle area is placed one centimeter in front of the medial and lateral malleoli. If there is a difference in the length of the lower limbs, the shortening will be compensated under the orthosis. In the conventional foot and ankle orthosis, shoes with a regular PU sole are worn. After the fitting, the patient wears the orthosis and shoes, and tests are performed. Intervention 2: Intervention group: The optimized ankle foot orthosis is made using a 5 mm thick polypropylene sheet for each patient after taking a mold and modifying the mold. In the optimized orthosis, the angle of the ankle in the orthosis will match the length of the gastrosoleus muscle. The orthosis extends from the tips of the toes to below the knee. The orthosis incision line in the ankle area is placed one centimeter in front of the medial and lateral ankles. If there is a difference in the length of the lower limbs, the shortening will be compensated under the orthosis. In the optimized combination, the shoe is worn with the optimized insole. After fitting, the patient wears the orthosis and shoe and tests are performed. Intervention 3: Control group: Without intervention. Yes - There is a plan to make this available What will be shared: Study information (other than personal information) will be shared with other researchers. When: Information is shared after results or data summaries are printed. To whom: Information will be shared for academic purposes only. Conditions: Information will be shared for teaching and research of applicants. Dr. Forghani (responsible administrator) will review the applications. Where to obtain: Individuals can request information from the designated responsible person. How to obtain: Applications should be sent via email to Saeed_forghany@yahoo.co.uk. Comments:
public Saeed forghany
Hezar Jerib Street, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences, Isfahan
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3792 5041 Saeed_forghany@yahoo.co.uk Esfahan University of Medical Sciences scientific Saeed Forghany
Hezar Jerib Street, Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences
Isfahan Iran (Islamic Republic of) 73461-81746 +98 31 3792 5041 Saeed_forghany@yahoo.co.uk Esfahan University of Medical Sciences Iran (Islamic Republic of) Spastic hemiplegic cerebral palsy Independent walking without the use of assistive devices (gross motor function classification 1-2) 5 years 15 years Both Presence of fix flexion contracture more than 25 degrees of the hip and knee joints severe symptoms of ataxia or dystonia History of surgery or specific disease in the trunk, lower limbs, elbow and wrist joints within the past 6 months Spasticity greater than 3 on the modified modified Ashworth scale in the upper and lower limbs Having severe communication and cognitive impairment (having scores of 4 and 5 on the Communication function classification system) Having a score of 5 on the MACS scale in the upper limb of the affected side G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation N/A Intervention group: The conventional foot and ankle orthosis is made for each patient using a 5 mm thick polypropylene sheet after taking a mold and modifying the mold. In this orthosis, the ankle will be at 90 degrees. The orthosis extends from the tips of the toes to below the knee. The orthosis incision line in the ankle area is placed one centimeter in front of the medial and lateral malleoli. If there is a difference in the length of the lower limbs, the shortening will be compensated under the orthosis. In the conventional foot and ankle orthosis, shoes with a regular PU sole are worn. After the fitting, the patient wears the orthosis and shoes, and tests are performed. Intervention group: The optimized ankle foot orthosis is made using a 5 mm thick polypropylene sheet for each patient after taking a mold and modifying the mold. In the optimized orthosis, the angle of the ankle in the orthosis will match the length of the gastrosoleus muscle. The orthosis extends from the tips of the toes to below the knee. The orthosis incision line in the ankle area is placed one centimeter in front of the medial and lateral ankles. If there is a difference in the length of the lower limbs, the shortening will be compensated under the orthosis. In the optimized combination, the shoe is worn with the optimized insole. After fitting, the patient wears the orthosis and shoe and tests are performed. Control group: Without intervention Trunk kinematic during gait. Timepoint: At the beginning of the study and immediately after receiving the interventions. Method of measurement: 3D gait recording and analysis system. Upper limbs kinematic during gait. Timepoint: At the beginning of the study and immediately after receiving the intervention. Method of measurement: 3D gait recording and analysis system. Walking ability. Timepoint: At the beginning of the study and immediately after receiving the intervention. Method of measurement: 1 minute walking test. Dynamic balance. Timepoint: At the beginning of the study and immediately after receiving the intervention. Method of measurement: Timed up and go test. Satisfaction. Timepoint: At the beginning of the study and immediately after receiving the intervention. Method of measurement: Structured interview. Spatial-temporal gait parameters. Timepoint: At the beginning of the study and immediately after receiving the intervention. Method of measurement: 3D gait recording and analysis system. Esfahan University of Medical Sciences Approved 2025-03-10 Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib Street, Isfahan University of Medical Sciences, Isfahan Isfahan Isfehan Iran (Islamic Republic of)