title: 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.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Cliniclatrials.gov Identifier: NCT01774669 (15 January 2013).
authors.affiliation: Research Department, Reha Rheinfelden, Salinenstrasse 98, 4310 Rheinfelden, Switzerland. c.schuster@reha-rhf.ch.
authors.forename: Corina
authors.initials: C
authors.lastname: Schuster-Amft
authors.forename: Kynan
authors.initials: K
authors.lastname: Eng
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lehmann
authors.forename: Ludwig
authors.initials: L
authors.lastname: Schmid
authors.forename: Nagisa
authors.initials: N
authors.lastname: Kobashi
authors.forename: Irène
authors.initials: I
authors.lastname: Thaler
authors.forename: Martin L
authors.initials: ML
authors.lastname: Verra
authors.forename: Andrea
authors.initials: A
authors.lastname: Henneke
authors.forename: Sandra
authors.initials: S
authors.lastname: Signer
authors.forename: Michael
authors.initials: M
authors.lastname: McCaskey
authors.forename: Daniel
authors.initials: D
authors.lastname: Kiper
mesh_terms: D001291:Attitude of Health Personnel; D002985:Clinical Protocols; D003071:Cognition; D004185:Disability Evaluation; D017144:Focus Groups; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007407:Interviews as Topic; D009043:Motor Activity; D009788:Occupational Therapy / Q000379:methods*; D010361:Patients / Q000523:psychology; D059825:Physical Therapists / Q000523:psychology; D026741:Physical Therapy Modalities; D011237:Predictive Value of Tests; D011569:Psychiatric Status Rating Scales; D020127:Recovery of Function; D012107:Research Design; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology; D000071939:Stroke Rehabilitation; D011795:Surveys and Questionnaires; D013557:Switzerland; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome; D034941:Upper Extremity / Q000294:innervation*; D014584:User-Computer Interface; D018910:Video Games