Abstract
BackgroundFifty percent of all stroke survivors remain with functional impairments of their upper limb. While there is a need to improve the effectiveness of rehabilitative training, so far no new training approach has proven to be clearly superior to conventional therapy. As training with rewarding feedback has been shown to improve motor learning in humans, it is hypothesized that rehabilitative arm training could be enhanced by rewarding feedback. In this paper, we propose a trial protocol investigating rewards in the form of performance feedback and monetary gains as ways to improve effectiveness of rehabilitative training.MethodsThis multicentric, assessor-blinded, randomized controlled trial uses the ArmeoSenso virtual reality rehabilitation system to train 74 first-ever stroke patients (< 100 days post stroke) to lift their impaired upper limb against gravity and to improve the workspace of the paretic arm. Three sensors are attached to forearm, upper arm, and trunk to track arm movements in three-dimensional space while controlling for trunk compensation. Whole-arm movements serve as input for a therapy game. The reward group (n = 37) will train with performance feedback and contingent monetary reward. The control group (n = 37) uses the same system but without monetary reward and with reduced performance feedback. Primary outcome is the change in the hand workspace in the transversal plane. Standard clinical assessments are used as secondary outcome measures.DiscussionThis randomized controlled trial will be the first to directly evaluate the effect of rewarding feedback, including monetary rewards, on the recovery process of the upper limb following stroke. This could pave the way for novel types of interventions with significantly improved treatment benefits, e.g., for conditions that impair reward processing (stroke, Parkinson’s disease).Trial registrationClinicalTrials.gov, ID: NCT02257125. Registered on 30 September 2014.
Highlights
MethodsThis multicentric, assessor-blinded, randomized controlled trial uses the ArmeoSenso virtual reality rehabilitation system to train 74 first-ever stroke patients (< 100 days post stroke) to lift their impaired upper limb against gravity and to improve the workspace of the paretic arm
Fifty percent of all stroke survivors remain with functional impairments of their upper limb
We use the ArmeoSenso, a standardized virtual reality (VR)-based training system [18] that is delivered in two versions for two different study groups, one version with and one without reward and enhanced performance feedback
Summary
Ethics and reporting The study protocol follows the Consolidated Standards of Reporting Trials (CONSORT) Statement on randomized trials of non-pharmacological treatment [19] and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT; see Fig. 5 for the SPIRIT Figure and the SPIRIT Checklist in Additional file 1) guidance for protocol reporting [20]. The randomization list containing the subject ID, the corresponding group allocation and a randomly generated password was sent to an independent (unblinded) study staff member (“admin”) who has set up respective patient-user computer accounts used for accessing the therapy game. After 60 min of net training time, the automated assessments will be repeated and the patient will be asked to fill in a short motivation questionnaire (see the “Secondary outcome” section) Both groups train with modified versions of the ArmeoSenso “METEORS” game (see [18, 21]). The money won during the preceding round, during the ongoing training session and the total money gathered over the whole course of the study, is presented on the feedback screen (Fig. 4a), which is followed by a high score list showing the top 10 results (Fig. 4b). Primary outcome: Workspace assessment Secondary outcomes: Fugl-Meyer Assessment – Upper
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