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A non-immersive virtual reality-based intervention to enhance lower-extremity motor function and gait in patients with subacute cerebral infarction: a pilot randomized controlled trial with 1-year follow-up
Bian M, Shen Y, Huang Y, Wu L, Wang Y, He S, Huang D, Mao Y
Frontiers in Neurology 2022 Oct 4;13(985700):Epub
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: This study was conducted to evaluate whether a non-immersive virtual reality (VR)-based intervention can enhance lower extremity movement in patients with cerebral infarction and whether it has greater short-term and long-term effectiveness than conventional therapies (CTs). MATERIALS AND METHODS: This was a single-blinded, randomized clinical controlled trial. Forty-four patients with subacute cerebral infarction were randomly allocated to the VR or CT group. All intervention sessions were delivered in the inpatient unit for 3 weeks. Outcomes were measured before (baseline) and after the interventions and at 3-month, 6-month and 1-year follow-ups. The outcomes included clinical assessments of movement and balance function using the Fugl-Meyer Assessment of Lower Extremity (FMA-LE) and Berg Balance Scale (BBS), and gait parameters in the sagittal plane. RESULTS: In the VR group, the walking speed after intervention, at 3-month, 6-month, and 1-year follow-ups were significantly greater than baseline (p = 0.01, < 0.001, 0.007, and < 0.001, respectively). Compared with baseline, BBS scores after intervention, at 3-month, 6-month, and 1-year follow-ups were significantly greater in both the VR group (p = 0.006, 0.002, < 0.001, and 0.001, respectively) and CT group (p = < 0.001, 0.002, 0.001, and < 0.001, respectively), while FMA-LE scores after intervention, at 3-month, 6-month, and 1-year follow-ups were significant increased in the VR group (p = 0.03, < 0.001, 0.003, and < 0.001, respectively), and at 3-month, 6-month, and 1-year follow-ups in the CT group (p = 0.02, 0.004 and < 0.001, respectively). In the VR group, the maximum knee joint angle in the sagittal plane enhanced significantly at 6-month follow-up from that at baseline (p = 0.04). CONCLUSION: The effectiveness of the non-immersive VR-based intervention in our study was observed after the intervention and at the follow-ups, but it was not significantly different from that of CTs. In sum, our results suggest that non-immersive VR-based interventions may thus be a valuable addition to conventional physical therapies to enhance treatment efficacy.

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