Abstract
Enriched environments and tools are believed to promote grasp rehabilitation after stroke. We designed S2, an interactive grasp rehabilitation system consisting of smart objects, custom orthoses for selective grasp constraining, and an electrode array system for forearm NMES. Motor improvements and perceived usability of a new enriched upper limb training system for sub-acute stroke patients was assessed in this interim analysis. Inclusion criteria: sub-acute stroke patients with , ipsilesional , and contralesional . Effects of 30-min therapy supplements, conventional vs. S2 prototype, are compared through a parallel two-arms dose-matched open-label trial, lasting 27 sessions. Clinical centres: Asklepios Neurologische Klinik Falkenstein, Königstein im Taunus, Germany, and Clinica Villa Beretta, Costa Masnaga, Italy. Assessment scales: ARAT, System Usability, and Technology Acceptance. Methodology: 26 participants were block randomized, allocated to the study (control , experimental ) and underwent the training protocol. Among them, 11 participants with ARAT score at inclusion below 35, n = 6 in the experimental group, and n = 5 in the control group were analysed. Results: participants in the enriched treatment group displayed a larger improvement in the ARAT scale (+14.9 pts, ). Perceived usability differed between clinics. No adverse effect was observed in relation to the treatments. Trial status: closed. Conclusions: The S2 system, developed according to shared clinical directives, was tested in a clinical proof of concept. Variations of ARAT scores confirm the feasibility of clinical investigation for hand rehabilitation after stroke.
Highlights
Stroke is the leading cause of disability in developed countries
The minimal clinically important difference (MCID) of the total Action Research Arm Test (ARAT) score in chronic stroke patients is approximated to 6 pt, roughly equal to 10% of the scale
According to Lang [31], in sub-acute stroke patients the patient-perceived MCID has to be considered of 12 pt for the dominant side, or 17 pt for the non-dominant side, representing 21% and 30% of the scale, respectively)
Summary
Stroke is the leading cause of disability in developed countries. Impairment affects the large majority of stroke survivors and most of them require rehabilitation. Effective treatment is timely required to avoid the learned non-use of the affected arm [1,2]. Increased life span in developed countries, and lowered averaged age of first stroke translate into higher occurrence of stroke, longer disability-adjusted life expectancy, and higher cumulative post-stroke assistance [3,4]. More recently the COVID-19 pandemic caused a surge in the stroke population [5,6,7] and is expected to substantially modify the scenarios of treatment and social care [8]. Stroke survivors need constant external assistance even in basic daily activities. Environmental and personal factors can hugely affect patients’ reactions and expectations [9,10] in the acute and sub-acute phase
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