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IRCT20240307061203N2 IRCT 2024-05-14 The University of Faisalabad virtual reality on trunk control and gross motor function in children with developmental delays Effect of virtual reality on trunk control and gross motor function in children with developmental delays 2024-02-17 anticipated 22 Complete https://irct.ir/trial/76754 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: developmental delays, trunk control, gross motor functions, trunk measurement scale, virtual reality, Randomization description: The randomization process will utilize a lottery method, where numbers generated by a computer will be drawn based on the sample size. The numbers will then be allocated to different groups in the poll, ensuring an effective distribution, Blinding description: In single blinded outcome assessors will kept unaware of which participants received the experimental treatment and which received the control intervention. This blinding helps to prevent conscious or unconscious biases that could influence the assessment of study outcomes. 2 gross motor developmental delays. Intervention 1: Active Control group: this group will receive handling and facilitation principle of neurodevelopmental treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. This intervention will be in three stages. In the initial stage, to stimulate flexors and extensors muscles dynamic co-activation and to maintain trunk upright without tilting body in sagital plane children will be asked to play with toys infront of them. In the second stage children will be asked to play with toys. Subsequently, toys will be placed at the child’s side to prompt weight shift, facilitating dynamic co-activation of trunk muscles and elongation of the weight-bearing side. In the third stage, elongation of the weight-bearing side will be continued by placing a toy at approximately 45 degree to induce trunk rotation in horizontal plane. Trunk rotation will be fostering on weight bearing side in this phase. Intervention 2: Intervention group: Patient in this group will receive handling and facilitation principle of neurodevelopment treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. along with immersive virtual reality treatment protocol. It will involves 18 sessions in alternating three days a week for 6 weeks. this session will last for 30 minutes, starting with 15 minute of neurodevelopmental treatment followed by 15 minutes of playing immersive VR games with 1 minute rest interval. The first game involves participants features a bird’s flight (bird’s back), task is to collect to collect golden coins with dynamic adaptation for head and trunk movements. The second game representing planetary exploration (solar system) with head-trunk rotations, and third game entails climbing a elevator ride fouces on sitting posture, elongation and weight transfer, promoting hand and body movement. 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 The University of Faisalabad
Faisal Town, West Canal Road, Faisalabad, Punjab
Faisalabad Pakistan 38000 0092413357916317 zainboota9698@gmail.com The University of Faisalabad scientific Dr. Warda Jabbar
Faisal Town, West canal Road Faisalabad, Punjab
Faisalabad Pakistan 38000 +92 313 8650848 Wardah.jabbar5@gmail.com The University of Faisalabad Pakistan Willing to participate and giving consent Both genders male/female Age limit of 3-8 years of children Being able to follow visual and verbal commands Gross motor function level II-IV Those with an appropriate cognitive level to understand a VR exercise program 3 years 8 years Both Inability to follow instructions Other Neurological disorders (polio, epilepsy, seizures, traumatic brain injury) Malignancies and Infectious disorders ( encephalitis, meningitis, malignancy, tumors ) Patients having musculoskeletal problems ( fracture, congenital hip dyspepsia) Spastic CP with Ashworth scale 2 + Any surgery within last 6 months A diagnosis of Autism or attention deficit disorders Psychiatric disorder or any cardiac anomalies affecting exercise intolerance Less than 4 months after undergoing surgery R62.0 Delayed milestone in childhood Rehabilitation Rehabilitation Active Control group: this group will receive handling and facilitation principle of neurodevelopmental treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. This intervention will be in three stages. In the initial stage, to stimulate flexors and extensors muscles dynamic co-activation and to maintain trunk upright without tilting body in sagital plane children will be asked to play with toys infront of them. In the second stage children will be asked to play with toys. Subsequently, toys will be placed at the child’s side to prompt weight shift, facilitating dynamic co-activation of trunk muscles and elongation of the weight-bearing side. In the third stage, elongation of the weight-bearing side will be continued by placing a toy at approximately 45 degree to induce trunk rotation in horizontal plane. Trunk rotation will be fostering on weight bearing side in this phase. Intervention group: Patient in this group will receive handling and facilitation principle of neurodevelopment treatment approach will be utilize to encourage trunk weight bearing, uprightness and elongation. along with immersive virtual reality treatment protocol. It will involves 18 sessions in alternating three days a week for 6 weeks. this session will last for 30 minutes, starting with 15 minute of neurodevelopmental treatment followed by 15 minutes of playing immersive VR games with 1 minute rest interval. The first game involves participants features a bird’s flight (bird’s back), task is to collect to collect golden coins with dynamic adaptation for head and trunk movements. The second game representing planetary exploration (solar system) with head-trunk rotations, and third game entails climbing a elevator ride fouces on sitting posture, elongation and weight transfer, promoting hand and body movement. Trunk control. Timepoint: Before and after 6 weeks of intervention. Method of measurement: Trunk control measurement scale. Gross motor function. Timepoint: Before and after 6 weeks of intervention. Method of measurement: Gross motor functional scale-88. Tone. Timepoint: Before and after 6 weeks of intervention. Method of measurement: Modified Ashworth Scale. Cognition. Timepoint: Before and after 6 weeks of intervention. Method of measurement: HINE performa section 3. The University of Faisalabad Approved 2024-01-05 Research and Ethics/ technical committe for The University of Faisalabad Faisal Town, West Canal Road, Faisalabad, Punjab Faisalabad Punjab Pakistan