Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial

Abstract

BackgroundRecovery of voluntary movement is a main rehabilitation goal. Efforts to identify effective upper limb (UL) interventions after stroke have been unsatisfactory. This study includes personalized impairment-based UL reaching training in virtual reality (VR) combined with non-invasive brain stimulation to enhance motor learning. The approach is guided by limiting reaching training to the angular zone in which active control is preserved (“active control zone”) after identification of a “spasticity zone”. Anodal transcranial direct current stimulation (a-tDCS) is used to facilitate activation of the affected hemisphere and enhance inter-hemispheric balance. The purpose of the study is to investigate the effectiveness of personalized reaching training, with and without a-tDCS, to increase the range of active elbow control and improve UL function.MethodsThis single-blind randomized controlled trial will take place at four academic rehabilitation centers in Canada, India and Israel. The intervention involves 10 days of personalized VR reaching training with both groups receiving the same intensity of treatment. Participants with sub-acute stroke aged 25 to 80 years with elbow spasticity will be randomized to one of three groups: personalized training (reaching within individually determined active control zones) with a-tDCS (group 1) or sham-tDCS (group 2), or non-personalized training (reaching regardless of active control zones) with a-tDCS (group 3). A baseline assessment will be performed at randomization and two follow-up assessments will occur at the end of the intervention and at 1 month post intervention. Main outcomes are elbow-flexor spatial threshold and ratio of spasticity zone to full elbow-extension range. Secondary outcomes include the Modified Ashworth Scale, Fugl-Meyer Assessment, Streamlined Wolf Motor Function Test and UL kinematics during a standardized reach-to-grasp task.DiscussionThis study will provide evidence on the effectiveness of personalized treatment on spasticity and UL motor ability and feasibility of using low-cost interventions in low-to-middle-income countries.Trial registrationClinicalTrials.gov, ID: NCT02725853. Initially registered on 12 January 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2377-6) contains supplementary material, which is available to authorized users.

Relationship Between Spasticity and Upper-Limb Movement Disorders in Individuals With Subacute Stroke Using Stochastic Spatiotemporal Modeling

“…27,28 Experimental Procedure Reach-to-grasp motion toward a hollow cone (6-cm diameter base) placed on a table at 4 target locations was recorded ( Figure 1). [29][30][31] A midsagittal reference frame was used to determine target locations. The 4 locations were at two-third arm length (near-center) and arm length (far-center) in the midsagittal plane and ~30 cm to the right/left (depending on hemiparetic side: contralateral/ipsilateral).…”

Mobile Self-Monitoring ECG Devices to Diagnose Arrhythmia that Coincide with Palpitations: A Scoping Review

“…Reed et al conducted a randomised control trial (RCT) [30] across multiple sites in the UK, deploying the AliveCor ECG device to ascertain symptomatic rhythm detection in patients attending the emergency department. Reed et al [30] recruited 242 participants over a period of 18 months, with 125 allocated to the intervention group and 117 to the control group. The findings from the RCT were positive and the primary outcome of identifying symptomatic rhythm detection was identified in 69 participants in the intervention group, and 11 participants in the control group.…”

“…Furthermore, 28.0% of participants reported having no problems or concerns when they sent a heart trace to the study team, while 32.0% of participants strongly agreed with having no problems recording a trace. Reed et al [30] reported that their study demonstrated the cost benefits of using the AliveCor ECG device relating to primary, community and secondary care for both the intervention and control groups. The authors identified a £108 cost saving for participants in the intervention group.…”

“…While no cost saving was identified for the control group, further analysis found that the cost saving per symptomatic rhythm diagnosis was less per patient in the intervention group (£474) compared to the control group (£1395). Reed et al [30] argue that their findings are generalizable from emergency medicine to general practice, across a myriad of health care systems. However, Reed et al [30] study reported findings based on the use and deployment of one particular ECG device.…”

“…Reed et al [30] argue that their findings are generalizable from emergency medicine to general practice, across a myriad of health care systems. However, Reed et al [30] study reported findings based on the use and deployment of one particular ECG device. While they did not state the justification(s) for choosing the AliveCor ECG device over other devices available on the market, the results have demonstrated the positive effects of using a mobile ECG device.…”