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IRCT20241119063772N1 IRCT 2025-05-08 Shahid Beheshti University of Medical Sciences Effectiveness of occupation-based bilateral training in children with unilateral spastic cerebral palsy Effectiveness of occupation-based bilateral training on participation in Activities of Daily Livings (ADLs) in 6-12 years old children with unilateral spastic cerebral palsy 2025-05-24 anticipated 30 Complete https://irct.ir/trial/80453 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be recruited from the clients referred to occupational therapy clinics in Tehran based on the inclusion criteria and will be allocated to the control and intervention groups using a random number table. Accordingly, one of the researchers who is not involved in the intervention process will determine the placement of the participants in one of the two control and intervention groups based on the random number table. Participants and the outcome assessor will be blind about group allocation, Blinding description: In this single-blind study, the outcome assessor will be blind to the allocation of participants to groups. 3 Children with unilateral cerebral palsy. Intervention 1: Intervention group: In the intervention group, which consists of 15 children, children with unilateral cerebral palsy receive bilateral upper and lower limb exercises, the precise protocol of which was designed by a panel of experts. The intervention is provided over 14 days both in the clinic setting and remotely (online). The number of hours of intervention in face-to-face sessions ranges from 3 to 5 hours, depending on the conditions (the child's attention level, etc.). Intervention 2: Control group: In this group, children with unilateral spastic hemiplegic cerebral palsy will receive routine occupational therapy to treat this condition. 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 There is no further information.
public Marzieh Pashmdar Fard
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, opposite Bu Ali Hospital, Damavand Street, Imam Hossein (AS) Square, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 m.pashmdarfard@gmail.com Shahid Beheshti University of Medical Sciences scientific Mahnaz Hejazi Shirmard
Shahid Beheshti University of Medical Sciences, Faculty of Rehabilitation Sciences, opposite Bu Ali Hospital, Damavand Street, Imam Hossein (AS) Square, Tehran
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7756 1721 m.hejazishirmard@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The child has received a diagnosis of spastic unilateral hemiplegia cerebral palsy. The child is between 6 and 12 years old. The child is at levels II, III, and IV of the GMFCS scale. The child is at levels II and III of the MACS scale. The child has the ability to grasp light objects and raise the more affected hand more than 15 cm above the table surface. The child has not received upper and lower limb surgery and Botox injections in the past 6 to 12 months and does not intend to do so during the implementation of the interventions. The child's intelligence score is above 70 6 years 12 years Both The family or the child is unwilling to continue the interventions. The child has uncontrolled seizures. The child has visual or cognitive problems. The child is unable to actively participate in the assessment process. G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Intervention group: In the intervention group, which consists of 15 children, children with unilateral cerebral palsy receive bilateral upper and lower limb exercises, the precise protocol of which was designed by a panel of experts. The intervention is provided over 14 days both in the clinic setting and remotely (online). The number of hours of intervention in face-to-face sessions ranges from 3 to 5 hours, depending on the conditions (the child's attention level, etc.). Control group: In this group, children with unilateral spastic hemiplegic cerebral palsy will receive routine occupational therapy to treat this condition. The level of children's participation in daily life activities. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: Canadian occupational performance measure. Assessing the ability level of children's balance and lower extremities. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: Pediatric balance scale. Assessing children's manual skills. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: Children's Hand-use Experience Questionnaire. Assessment of gross motor skills. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: The Gross Motor Function Measure. Assessing the level of upper extremities ability and manual dexterity. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: Box and Block Test. Investigating the level of children's participation in daily life activities. Timepoint: All study variables will be assessed before the start, after the intervention (day 14), and one month after the intervention (follow-up assessment). Method of measurement: Pediatric Evaluation of Disability Inventory. Shahid Beheshti University of Medical Sciences Approved 2024-11-10 Research Ethics Committee of Shahid Beheshti University of Medical Sciences Vice President of Resear Shahid Beheshti University of Medical Sciences, School of Rehabilitation, opposite Bu Ali Hospital, Damavand Street (New Tehran), Imam Hossein (AS) Square, Tehran tehran Tehran Iran (Islamic Republic of)