Immersive virtual reality applied to the rehabilitation of patients with lower limb amputation: a small randomized controlled trial for feasibility study

Abstract

AbstractLimb amputation significantly impacts the socioeconomic and health aspects of affected individuals, with clinical issues such as phantom limb pain (PLP), phantom limb telescopy (PLT), residual limb pain (RLP), and decreased balance necessitating improved treatments. Although interventions utilizing Immersive Virtual Reality (IVR) have been explored, conducting Randomized Clinical Trials (RCT) within this population presents challenges. This study serves as a feasibility study derived from a small RCT, aiming to investigate the effects of an IVR intervention protocol on individuals with lower limb amputation (LLA) while addressing methodological challenges and exploring alternative study designs. Participants were randomly assigned to either the Control Group (CG), receiving no intervention, or the Intervention Group (IG), undergoing 16 IVR sessions over 8 weeks, with twenty-one participants completing the protocol. Sessions involved observing physical exercises via a head-mounted display. All participants were assessed for pain and balance pre- and post-intervention. IG participants were also evaluated for pain, sense of presence in the virtual environment, and cybersickness on intervention days. Results indicated a significant negative correlation between RLP and time since amputation in the Intervention Group. Analysis of results between IG and CG post-assessment suggests potential benefits of IVR in improving balance and reducing PLT. Despite challenges related to sample size and participant retention, multicenter collaborations and home-based interventions are proposed to mitigate these limitations. This feasibility study lays a foundation for future research aiming to optimize VR interventions for improved outcomes in patients with LLA.