VR-based cognitive rehabilitation for children with traumatic brain injuries: Feasibility and safety.

Abstract

Impact and ImplicationsChildhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs), yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the safety and efficacy of such interventions remain lacking. Per the ORBIT model, this study served as the Phase II (a-b) of randomized clinical trials to conduct preliminary testing on the feasibility and safety of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood TBI. Knowledge from this research serves as the empirical basis for the next phase of the research program to evaluate the efficacy of the VR program in pediatric TBI cognitive rehabilitation.

Virtual Reality–Based Neurorehabilitation Support Tool for People With Cognitive Impairments Resulting From an Acquired Brain Injury: Usability and Feasibility Study

“…We aimed to recruit enough inpatients with ABI to identify all usability problems in the design [54] and the early stage of this self-developed VR tool and to gather sufficient data to estimate the SD of measured outcomes for planning a subsequent larger trial [55]. Recent studies, which involved new-generation headsets, customized VR-based rehabilitation tools, focused on patient needs, tested the system in samples ranging from 11 to 35 patients with ABI, and found that VR was accepted and feasible for rehabilitation [37,38,56].…”

“…Additionally, the authors conducted second-phase trials to effectively evaluate the feasibility and preliminary efficacy of the VR-based intervention. Their primary findings suggest improvements in outcome measures of cognitive functions when the intervention is tailored to address the specific cognitive function, incorporating serious games techniques, using a patient-centered design approach, and administering sessions lasting approximately 30 minutes each [38][39][40][41].…”

Advances in Neurorehabilitation: Strategies and Outcomes for Traumatic Brain Injury Recovery

“…It has shown that it is an intervention with potential efficacy in moderate to severe TBI and its safety. The intervention group reported adequate VR satisfaction, low levels of physical exertion, and simulator sickness [73].…”

Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial

“…Power analyses were conducted in G*Power 3.1 to determine the sample size required for the proposed R00 study. We estimated the long-term intervention effect size to be 0.94 (Cohen’s d ) based on the preliminary data collected from children with moderate/severe TBIs from baseline to follow-up in a pilot study conducted prior to this project [ 28 ]. Using a directional one-tail test (as the intervention is expected to improve EFs) and alpha = 0.05, a total sample size of 30 participants is required to offer a power of 0.80.…”

“…This assessment will be administered immediately (up to 2 weeks) after the completion of the intervention. Although this measure has been used in previous pediatric TBI research its psychometric properties are unknown [ 28 ].…”