Using mixed methods to evaluate efficacy and user expectations of a virtual reality-based training system for upper-limb recovery in patients after stroke: a study protocol for a randomised controlled trial.

Background: In recent years, virtual reality has been introduced to neurorehabilitation, in particular with the intention of improving upper-limb training options and facilitating motor function recovery.

Methods/design: The proposed study incorporates a quantitative part and a qualitative part, termed a mixed-methods approach: (1) a quantitative investigation of the efficacy of virtual reality training compared to conventional therapy in upper-limb motor function are investigated, (2a) a qualitative investigation of patients' experiences and expectations of virtual reality training and (2b) a qualitative investigation of therapists' experiences using the virtual reality training system in the therapy setting. At three participating clinics, 60 patients at least 6 months after stroke onset will be randomly allocated to an experimental virtual reality group (EG) or to a control group that will receive conventional physiotherapy or occupational therapy (16 sessions, 45 minutes each, over the course of 4 weeks). Using custom data gloves, patients' finger and arm movements will be displayed in real time on a monitor, and they will move and manipulate objects in various virtual environments. A blinded assessor will test patients' motor and cognitive performance twice before, once during, and twice after the 4-week intervention. The primary outcome measure is the Box and Block Test. Secondary outcome measures are the Chedoke-McMaster Stroke Assessments (hand, arm and shoulder pain subscales), the Chedoke-McMaster Arm and Hand Activity Inventory, the Line Bisection Test, the Stroke Impact Scale, the MiniMentalState Examination and the Extended Barthel Index. Semistructured face-to-face interviews will be conducted with patients in the EG after intervention finalization with a focus on the patients' expectations and experiences regarding the virtual reality training. Therapists' perspectives on virtual reality training will be reviewed in three focus groups comprising four to six occupational therapists and physiotherapists.

Discussion: The interviews will help to gain a deeper understanding of the phenomena under investigation to provide sound recommendations for the implementation of the virtual reality training system for routine use in neurorehabilitation complementing the quantitative clinical assessments.

Trial Registration: Cliniclatrials.gov Identifier: NCT01774669 (15 January 2013).