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Virtual reality for upper limb rehabilitation in sub-acute and chronic stroke: a randomized controlled trial
Kiper P, Szczudlik A, Agostini M, Opara J, Nowobilski R, Ventura L, Tonin P, Turolla A
Archives of Physical Medicine and Rehabilitation 2018 May;99(5):834-842
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; 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*

OBJECTIVE: To evaluate the effectiveness of reinforced feedback in virtual environment (RFVE) treatment combined with conventional rehabilitation (CR) in comparison with CR alone, and to study whether changes are related to stroke aetiology (ie, ischemic or hemorrhagic). DESIGN: Randomized controlled trial. SETTING: Inpatients in a hospital facility for intensive rehabilitation. PARTICIPANTS: 136 patients within one year from onset of a single stroke. INTERVENTIONS: The experimental treatment was based on the combination of RFVE with CR, while control treatment was based on the same amount of CR. Both treatments lasted 2 hours daily, 5 days a week, for 4 weeks. MAIN OUTCOME MEASURES: Fugl-Meyer upper extremity (F-M UE) scale (primary outcome), Functional Independence Measure (FIM), National Institutes of Health Stroke Scale (NIHSS), and Edmonton Symptom Assessment Scale (ESAS) (secondary outcomes). Kinematic parameters of requested movements: duration (Time), mean linear velocity (Speed), number of submovements (Peak) (secondary outcomes). RESULTS: 136 patients (ischemic = 78, hemorrhagic = 58) were randomized in two groups (RFVE = 68, CR = 68) and stratified by stroke aetiology (ischemic, hemorrhagic). Both groups improved after treatment, but the experimental group had better results than the control group (Mann-Whitney U test) at: F-M UE (p < 0.001), FIM (p < 0.001), NIHSS (p <= 0.014), ESAS (p <= 0.022), time (p < 0.001), speed (p < 0.001), peak (p < 0.001). Stroke aetiology did not have significant effects on patient outcomes. CONCLUSION: The RFVE therapy combined with CR treatment promotes better outcomes for upper limb than the same amount of CR, regardless of stroke aetiology (clinical trial registration -- NCT01955291).

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