Abstract
BackgroundRecovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone.Methods/DesignA prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle.DiscussionBy enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone.Trial registrationACTRN12608000457347
Highlights
Recovery of upper limb function after stroke is poor
The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement when compared to usual therapy alone
The primary aim of the current randomised controlled trial (RCT) is to determine the ability of SMART Arm training with or without OT-stim compared to usual therapy to improve upper limb function in stroke survivors with severe upper limb disability undergoing inpatient rehabilitation
Summary
This will be the first prospective trial to compare the effect of dose-matched volumes of SMART Arm with OTstim and usual therapy, versus SMART Arm alone with usual therapy versus usual therapy alone during inpatient rehabilitation following stroke. It is likely that gait training requirements, which are paramount to determining discharge destination, are prioritised Another option is robotic therapy, availability is currently limited and functional outcomes remain inconclusive [8,41,42]. Improvements in impairments and activity using the SMART Arm have been obtained in chronic stroke survivors [16], and the indications from our pilot work are that similar outcomes may be achieved in those undertaking inpatient rehabilitation [19]. This study will allow the impact of augmenting training with electrical stimulation to be assessed in the context of severe motor disability This will be the first large study to determine the effect of outcome-triggered stimulation, in circumstances in which the stroke survivor is rewarded for performing the desired movement, rather than for generating sufficient levels of EMG i.e. regardless of the functional consequences.
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