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IRCT20240307061203N1 IRCT 2024-03-24 The University of Faisalabad virtual reality on trunk control with developmental delays Effect of virtual reality on trunk control in children with developmental delays 2024-02-17 anticipated 22 Complete https://irct.ir/trial/76080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: developmental delays, trunk control measurement scale, Randomization description: The randomization will be done with the help of lottery method. Lottery generated numbers will be drawn from the computer by the help of sample size. Different numbers will enter in the poll of group, Blinding description: single blinded: outcome assessors are typically kept unaware of which participants received the experimental treatment and which received the control or comparative intervention. This blinding helps to prevent conscious or unconscious biases that could influence the assessment of study outcomes. 2-3 Delayed developmental milestone. 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 24 sessions in alternating three days a week for 8 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. Yes - There is a plan to make this available What will be shared: Effect of virtual reality on trunk control in children with developmental delays When: 15 days after publication To whom: google scholar Conditions: Access to the data will be facilitated through a specified mechanism, such as a secure online portal or data sharing platform. Requests for access will be reviewed by a designated committee or entity responsible for ensuring that they meet the established criteria and comply with relevant regulations and guidelines. Additional supporting information and documents may be provided to assist requesters Where to obtain: The University of Faisalabad 38000 https://tuf.edu.pk/ 00924187509715 How to obtain: To receive the documents or data files, the process typically involves the following steps: 1. Request Initiation: The applicant submits a formal request specifying the documents or data files they need. 2. Verification and Authorization: The organization verifies the request and ensures that the applicant is authorized to access the requested documents or data files. This may involve confirming the identity of the requester and checking their permissions. 3. Processing Time: The processing time varies depending on the complexity of the request, the volume of documents or data files, and any legal or regulatory requirements. It could range from a few hours to several weeks. 4. Document Retrieval or Data Extraction: Once the request is approved, the organization retrieves the documents from their archives or extracts the requested data from their databases. 5. Quality Assurance: Before releasing the documents or data files to the applicant, the organization may conduct quality checks to ensure accuracy and completeness. 6. Delivery: The documents or data files are delivered to the applicant through a secure channel, such as encrypted email, secure file transfer protocols, or a secure online portal. 7. Confirmation of Receipt: The applicant acknowledges receipt of the documents or data files, confirming that they have received the information they requested. Comments:
public Dr. Zainab Boota
Faisal Town, West Canal Road, Faisalabad, Punjab
Faisalabad Pakistan 38000 0092413357916317 zainboota9698@gmail.com The University of Faisalabad scientific Dr. warda jabbar;PT
Faisal Town, West canal Road Faisalabad, punjab
Faisalabad Pakistan 38000 0092 41 313 8650848 Wardah.jabbar5@gmail.com The University of faisablabad Pakistan Willing to give consent. Both gender male/female Age limit 3-8 years 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) Malgnanices and Infectious disorders ( encephalitis, meningitis, malignancy, tumors ) Patients having musculoskeletal problems ( fracture, congenital hip dysplesia) Spastic CP with Ashworth scale 2 + Any surgery within last 6 months A diagnosis of Autism or attention deficit disorders Psychiatric disorder 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 24 sessions in alternating three days a week for 8 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. 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