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Effect of a four-week virtual reality-based training versus conventional therapy on upper limb motor function after stroke: a multicenter parallel group randomized trial
Schuster-Amft C, Eng K, Suica Z, Thaler I, Signer S, Lehmann I, Schmid L, McCaskey MA, Hawkins M, Verra ML, Kiper D
PLoS ONE 2018 Oct;13(10):e0204455
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*

BACKGROUND: Virtual reality-based training has found increasing use in neurorehabilitation to improve upper limb training and facilitate motor recovery. OBJECTIVE: The aim of this study was to directly compare virtual reality-based training with conventional therapy. METHODS: In a multi-center, parallel-group randomized controlled trial, patients at least 6 months after stroke onset were allocated either to an experimental group (virtual reality-based training) or a control group receiving conventional therapy (16 x 45 minutes within 4 weeks). The virtual reality-based training system replicated patients' upper limb movements in real-time to manipulate virtual objects. Blinded assessors tested patients twice before, once during, and twice after the intervention up to 2-month follow-up for dexterity (primary outcome: Box and Block Test), bimanual upper limb function (Chedoke-McMaster Arm and Hand Activity Inventory), and subjective perceived changes (Stroke Impact Scale). RESULTS: 54 eligible patients (70 screened) participated (15 females, mean age 61.3 years, range 20 to 81 years, time since stroke 3.0 +/- SD 3 years). 22 patients were allocated to the experimental group and 32 to the control group (3 drop-outs). Patients in the experimental and control group improved: Box and Block Test mean 21.5 +/- SD 16 baseline to mean 24.1 +/- SD 17 follow-up; Chedoke-McMaster Arm and Hand Activity Inventory mean 66.0 +/- SD 21 baseline to mean 70.2 +/- SD 19 follow-up. An intention-to-treat analysis found no between-group differences. CONCLUSIONS: Patients in the experimental and control group showed similar effects, with most improvements occurring in the first two weeks and persisting until the end of the two-month follow-up period. The study population had moderate to severely impaired motor function at entry (Box and Block Test mean 21.5 +/- SD 16). Patients, who were less impaired (Box and Block Test range 18 to 72) showed higher improvements in favor of the experimental group. This result could suggest that virtual reality-based training might be more applicable for such patients than for more severely impaired patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT01774669.

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