1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  Proposals should be directed to sylajapn@hotmail.com


6. For how long will this data be available start date provided 07-11-2025 and end date provided 06-11-2028?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

The proposed project is to build a comprehensive, large-scale computational neural model of the key parts of the brain involved in the control of upper extremities. The model must simulate the effects of specific stroke lesions and their effects on arm movements. The model allows customization to a given patient based on measurements of the site, location, disruption in the structure-function relation in the stroke-afflicted brain. Proposed treatment modalities will be first simulated on the model, and only the most effective solutions will be administered to the patient. The use of such large-scale, comprehensive computational models for the treatment of neurological disease can be a game-changer in clinical neuroscience. It has the potential to transform the current empirical traditions of clinical neurology, into a quantitative, data and model-driven, scientific practice.

The objectives of the project is

1. Development of the large-scale, computational neuroscience model:
2. Movement analysis and modeling:
3. Development of Virtual Reality-based Gaming system
4. Clinical: Evaluating the feasibility and efficacy of virtual reality-based gaming in stroke survivors with impairment of the upper extremity
5. Neuroimaging: Measurement of pre-treatment and post-treatment recovery process in the  function of the brain using resting-state functional imaging studies

Hypothesis: The hypothesis for our study is that the proposed VR gaming-based rehabilitation scheme gives better clinical outcomes than a comparable traditional rehabilitation scheme. Combined with the computational modeling effort, it is expected that we can bridge the gaps in terms of characterizing, on the one hand, the relation between VR gaming parameters and the behavioral improvements and on the other hand probe the neural substrates of these improvements. It is also envisaged that the computational models allow us to customize the therapies for individual patients.

Study Methodology: In the patients who fulfill the inclusion criteria, informed consent will be taken and then baseline NIHSS, Wolf motor function test, Fugl Meyer score for upper limb will be done. In addition, a quality-of-life scale - SF 36, mRS, and Barthel Index will be done. Following this patients will be randomized either to intervention or control group using the software. Then they undergo MRI brain protocol which includes resting-state functional MRI which will be done at baseline and after 12 weeks of therapy.

Each arm will receive the therapy for 12 weeks, 3 sessions per week. Each session will be for 30-45 minutes each. The conventional arm will receive routine therapy for strengthening and functional activities and the intervention arm will receive training on virtual reality-based gaming. A repeat assessment of the Wolf motor function test, Fugl Meyer score for upper limb, quality of life assessment mRS, and Barthel Index will be done at the end of 3 months. In addition,10  healthy controls will undergo MRI brain protocol including resting-state functional MRI which will be important for the modeling.