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IRCT20250629066292N1 IRCT 2025-07-21 Tehran University of Medical Sciences Development of Rehabilitation Protocols Based on Predictive Modeling of the Effects of Mechanical Vibrations and Robotics on Neuromuscular Control and Gait Improvement in Children with Cerebral Palsy Development of Rehabilitation Protocols Based on Predictive Modeling of the Effects of Mechanical Vibrations and Robotics on Neuromuscular Control and Gait Improvement in Children with Cerebral Palsy 2025-08-11 anticipated 36 Recruiting https://irct.ir/trial/84799 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomly allocated to either an intervention group or a control group. The randomization process will be performed using the RAND() function in Microsoft Excel. N/A Condition 1: Children with spastic hemiplegic Cerebral Palsy. Condition 2: Children with spastic diplegic Cerebral Palsy. Intervention 1: Intervention group: The intervention group will undergo treatment with the neuromuscular rehabilitation robot for 30 minutes per session, 3 times a week, over a two-month period. Participants will be seated on the adjustable chair of the robot, and their ankle will be secured in a custom brace to ensure the ankle joint's axis of rotation is aligned with that of the robot's motor .The appropriate range of motion (ROM) for the individual's ankle joint is determined. During the treatment session, low-amplitude, high-frequency vibrations are applied to the individual, both throughout the entire range of motion and statically at the end-range of dorsiflexion. Intervention 2: Control group: Children in the control group will receive a conventional occupational therapy program for the same duration and frequency, with a focus on reducing ankle spasticity. 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 At this stage of the project, a formal plan for sharing the de-identified Individual Participant Data (IPD) has not yet been developed. The decision regarding data sharing will be made after the completion of the study, following a thorough review of the participant consent forms and our institution's data sharing policies to ensure that patient confidentiality is fully protected.
public Mohammad Mehdi Mirbagheri
Poursina st, Tehran university of medical science
Tehran Iran (Islamic Republic of) 1416753955 +98 21 8891 2090 mehdi.northwestern@gmail.com Tehran University of Medical Sciences scientific Mohammad Mehdi Mirbagheri
Poursina st, Tehran university of medical science
Tehran Iran (Islamic Republic of) 1416753955 +98 21 8891 2090 mehdi.northwestern@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosed with spastic hemiplegic and diplegia Cerebral Palsy (CP). Ability to participate in the scheduled treatment and assessment sessions. Ability to communicate and follow instructions. 3 years 18 years Both Severe intellectual disability. A history of uncontrolled epilepsy or untreated seizures. G80.2 G80.1 Spastic hemiplegic cerebral palsy Spastic diplegic cerebral palsy Rehabilitation Rehabilitation Intervention group: The intervention group will undergo treatment with the neuromuscular rehabilitation robot for 30 minutes per session, 3 times a week, over a two-month period. Participants will be seated on the adjustable chair of the robot, and their ankle will be secured in a custom brace to ensure the ankle joint's axis of rotation is aligned with that of the robot's motor .The appropriate range of motion (ROM) for the individual's ankle joint is determined. During the treatment session, low-amplitude, high-frequency vibrations are applied to the individual, both throughout the entire range of motion and statically at the end-range of dorsiflexion. Control group: Children in the control group will receive a conventional occupational therapy program for the same duration and frequency, with a focus on reducing ankle spasticity. Stiffness. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Neuromuscular rehabilitation robot. Active range of motion. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Position sensor of the neuromuscular rehabilitation robot. Maximum voluntary contraction force. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Torque sensor of the neuromuscular rehabilitation robot. Speed of voluntary joint movement. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Position sensor of the neuromuscular rehabilitation robot. Ankle joint angles. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Using marker positions in the motion capture lab. Maximum step height. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Using marker positions in the motion capture lab. Center of pressure fluctuations. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Force plate. Static stability. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Force plate. Timed up and Go. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Stopwatch. 10-meter walk test. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Stopwatch. 6-minute walk test. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), After two months of receiving the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Meter. Tehran University of Medical Sciences Approved 2025-05-11 Tehran University of Medical Sciences Research Ethics Committee Poursina st, Tehran university of medical science Tehran Tehran Iran (Islamic Republic of)