Abstract
BackgroundImpaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery. The SaeboGlove assists digital extension and may improve outcome after stroke. We recently performed a single group, open, pilot trial of the SaeboGlove early after stroke which demonstrated satisfactory safety, feasibility and acceptability. An adequately powered randomised clinical trial is now needed to assess the clinical effectiveness of the SaeboGlove.MethodsSUSHI is a pragmatic, multicentre, parallel-group, randomised controlled trial with blinded outcome assessment, and embedded process and economic evaluations. Adults, 7–60 days post-stroke, with upper limb disability and severe hand impairment, including reduced active digital extension, will be recruited from NHS inpatient stroke services in Scotland. Participants will be randomised on a 1:1 basis to receive 6 weeks of self-directed, repetitive, functional-based practice involving a SaeboGlove plus usual care, or usual care only. The primary outcome is upper limb function measured by the Action Research Arm Test (ARAT) at 6 weeks. Secondary outcomes will be measured at 6 and 14 weeks. A process evaluation will be performed via interviews with ‘intervention’ participants, and their carers and clinical therapists. A within-trial cost-effectiveness analysis will be performed. 110 participants are required to detect a difference between groups of 9 in the ARAT with 90% power at a 5% significance level allowing for 11% attrition.DiscussionSUSHI will determine if SaeboGlove self-directed, repetitive, functional-based practice improves upper limb function after stroke, whether it is acceptable to stroke survivors and whether it is cost-effective.
Highlights
Impaired active digital extension is common after stroke, hindering functional rehabilitation, and predicting poor recovery
It affects around 80% of people with stroke[2] and approximately 50% of them have no improvement in upper limb function six months post-stroke.[3]
We describe the SUSHI trial
Summary
Stroke is the third leading cause of disability worldwide.[1]. Upper limb motor impairment contributes significantly to the burden experienced by stroke survivors. The SaeboGlove is a CE marked mechanical hand orthosis already used in some health services It consists of a glove, fixed using velcro inside a wrist splint (Figure 1),[18] and offers digital extensor assistance using tensioner bands which span between hooks over weak joints to enable hand opening.[18] it improves access to repetitive, functional-based upper limb rehabilitation and self-practice opportunities,[19] regardless of extensor weakness severity. This might promote engagement in recommended rehabilitation activities and improve long-term recovery; addressing key priorities in stroke care. We hypothesise that upper limb function (ARAT) will be significantly greater in the intervention group immediately post intervention
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