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Feasibility, safety and efficacy of a virtual reality exergame system to supplement upper extremity rehabilitation post-stroke: a pilot randomized clinical trial and proof of principle
Norouzi-Gheidari N, Hernandez A, Archambault PS, Higgins J, Poissant L, Kairy D
International Journal of Environmental Research & Public Health 2020 Jan;17(1):113
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

(1) BACKGROUND: Increasing the amount of therapy time has been shown to improve motor function in stroke survivors. However, it is often not possible to increase the amount of therapy time provided in the current one-on-one therapy models. Rehabilitation-based virtual reality exergame systems, such as Jintronix, can be offered to stroke survivors as an adjunct to traditional therapy. The goal of this study was to examine the safety and feasibility of providing additional therapy using an exergame system and assess its preliminary clinical efficacy. (2) METHODS: Stroke survivors receiving outpatient rehabilitation services participated in this pilot randomized control trial in which the intervention group received 4 weeks of exergaming sessions in addition to traditional therapy sessions. (3) RESULTS: Nine subjects in the intervention and nine subjects in the control group completed the study. The intervention group had at least two extra sessions per week, with an average duration of 44 min per session and no serious adverse events (falls, dizziness, or pain). The efficacy measures showed statistically meaningful improvements in the activities of daily living measures (ie, MAL-QOM (motor activity log-quality of movement) and both mobility and physical domains of the SIS (stroke impact scale) with mean difference of 1.0%, 5.5%, and 6.7% between the intervention and control group, respectively) at post-intervention. (4) CONCLUSION: Using virtual reality exergaming technology as an adjunct to traditional therapy is feasible and safe in post-stroke rehabilitation and may be beneficial to upper extremity functional recovery.

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