Evaluation of upper extremity neurorehabilitation using technology: a European Delphi consensus study within the EU COST Action Network on Robotics for Neurorehabilitation.

BACKGROUND: The need for cost-effective neurorehabilitation is driving investment into technologies for patient assessment and treatment. Translation of these technologies into clinical practice is limited by a paucity of evidence for cost-effectiveness. Methodological issues, including lack of agreement on assessment methods, limit the value of meta-analyses of trials. In this paper we report the consensus reached on assessment protocols and outcome measures for evaluation of the upper extremity in neurorehabilitation using technology. The outcomes of this research will be part of the development of European guidelines. METHODS: A rigorous, systematic and comprehensive modified Delphi study incorporated questions and statements generation, design and piloting of consensus questionnaire and five consensus experts groups consisting of clinicians, clinical researchers, non-clinical researchers, and engineers, all with working experience of neurological assessments or technologies. For data analysis, two major groups were created: i) clinicians (e.g., practicing therapists and medical doctors) and ii) researchers (clinical and non-clinical researchers (e.g. movement scientists, technology developers and engineers). RESULTS: Fifteen questions or statements were identified during an initial ideas generation round, following which the questionnaire was designed and piloted. Subsequently, questions and statements went through five consensus rounds over 20 months in four European countries. Two hundred eight participants: 60 clinicians (29 %), 35 clinical researchers (17 %), 77 non-clinical researchers (37 %) and 35 engineers (17 %) contributed. At each round questions and statements were added and others removed. Consensus (≥69 %) was obtained for 22 statements on i) the perceived importance of recommendations; ii) the purpose of measurement; iii) use of a minimum set of measures; iv) minimum number, timing and duration of assessments; v) use of technology-generated assessments and the restriction of clinical assessments to validated outcome measures except in certain circumstances for research. CONCLUSIONS: Consensus was reached by a large international multidisciplinary expert panel on measures and protocols for assessment of the upper limb in research and clinical practice. Our results will inform the development of best practice for upper extremity assessment using technologies, and the formulation of evidence-based guidelines for the evaluation of upper extremity neurorehabilitation.

Designing a placebo device: involving service users in clinical trial design.

BACKGROUND: Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. AIMS: To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. DESIGN: Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. CONTENT OF THE FORA: A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. CONCLUSION AND DISCUSSION: This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability.

Decoding emotional prosody in Parkinson's disease and its potential neuropsychological basis.

Parkinson's disease patients may have difficulty decoding prosodic emotion cues. These data suggest that the basal ganglia are involved, but may reflect dorsolateral prefrontal cortex dysfunction. An auditory emotional n-back task and cognitive n-back task were administered to 33 patients and 33 older adult controls, as were an auditory emotional Stroop task and cognitive Stroop task. No deficit was observed on the emotion decoding tasks; this did not alter with increased frontal lobe load. However, on the cognitive tasks, patients performed worse than older adult controls, suggesting that cognitive deficits may be more prominent. The impact of frontal lobe dysfunction on prosodic emotion cue decoding may only become apparent once frontal lobe pathology rises above a threshold.