Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training on Sitting Balance and Quality of Life in individuals with Incomplete Spinal Cord Injury: Study Protocol for a Randomized Controlled Trial

Background : Individuals with incomplete Spinal Cord Injury (iSCI) often face significant impairments in sitting balance and mobility due to trunk instability. These challenges can severely impact functional abilities, participation in daily activities and overall Quality of Life (QoL). Studies have highlighted the potential of virtual reality (VR) training to improve sitting balance in individuals with iSCI. Furthermore, Sensory Electrical Stimulation (SES) has shown positive effects on sitting balance in various neurological populations. However, research exploring the combined effectiveness of VR and SES on sitting balance and QoL specifically within the iSCI human population remains limited. Methodology : This study will be a double-blind parallel, two-group, randomized controlled trial that aims to evaluate the effectiveness of SES augmented VR training on sitting balance and QoL in individuals with iSCI. A total of 22 participants with iSCI, with a neurological level of injury between T6 and T12 will be recruited from the rehabilitation department at the Indian Spinal Injuries Centre, adhering to inclusion criteria. Participants will be randomly assigned to one of two groups using a 1:1 allocation ratio. The intervention group will engage in VR-based balance training along with SES application, while the control group will solely engage in VR-based balance training. Both groups will undergo interventions consisting of 30-minute sessions, five times a week for a duration of 4 weeks. Outcome measures : The assessment of sitting balance will be done using the Modified Functional Reach Test (mFRT) and the Star Test using the Tecnobody Prokin 252 Trunk Sensor. Additionally, the International Spinal Cord Society Quality of Life Basic Data Set (ISCoS QoL BDS) Version 1.0 will be used to measure QoL. Discussion : The effectiveness of the SES augmented VR based balance training program will be evaluated based on the changes in the mFRT, Star Test (Prokin 252 Trunk Sensor) and ISCoS Quality of Life Basic Data Set Version 1.0 following four weeks of intervention. This trial aims to enhance understanding of how SES augmented VR training can improve sitting balance and QoL in individuals with iSCI. Trial Registration : The trial is registered with the Clinical Trials Registry – India on 18 ^th April 2024 with registration number CTRI/2024/04/065897.