Levin, M. F., Berman, S., Weiss, N., Parmet, Y., Banina, M. C., Frenkel-Toledo, S., et al. (2023). ENHANCE proof-of-concept three-arm randomized trial: effects of reaching training of the hemiparetic upper limb restricted to the spasticity-free elbow range (Vol. 13).
Abstract: Post-stroke motor recovery processes remain unknown. Timescales and patterns of upper-limb (UL) recovery suggest a major impact of biological factors, with modest contributions from rehabilitation. We assessed a novel impairment-based training motivated by motor control theory where reaching occurs within the spasticity-free elbow range. Patients with subacute stroke (</= 6 month; n = 46) and elbow flexor spasticity were randomly allocated to a 10-day UL training protocol, either personalized by restricting reaching to the spasticity-free elbow range defined by the tonic stretch reflex threshold (TSRT) or non-personalized (non-restricted) and with/without anodal transcranial direct current stimulation. Outcomes assessed before, after, and 1 month post-intervention were elbow flexor TSRT angle and reach-to-grasp arm kinematics (primary) and stretch reflex velocity sensitivity, clinical impairment, and activity (secondary). Results were analyzed for 3 groups as well as those of the effects of impairment-based training. Clinical measures improved in both groups. Spasticity-free range training resulted in faster and smoother reaches, smaller (i.e., better) arm-plane path length, and closer-to-normal shoulder/elbow movement patterns. Non-personalized training improved clinical scores without improving arm kinematics, suggesting that clinical measures do not account for movement quality. Impairment-based training within a spasticity-free elbow range is promising since it may improve clinical scores together with arm movement quality.Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique Identifier: NCT02725853; Initial registration date: 01/04/2016.
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Levin, M. F., Banina, M. C., Frenkel-Toledo, S., Berman, S., Soroker, N., Solomon, J. M., et al. (2018). Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial. Trials, 19(1), 7.
Abstract: BACKGROUND: Recovery 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. METHODS: This 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov, ID: NCT02725853 . Initially registered on 12 January 2016.
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Banina, M. C., Molad, R., Solomon, J. S., Berman, S., Soroker, N., Frenkel-Toledo, S., et al. (2020). Exercise intensity of the upper limb can be enhanced using a virtual rehabilitation system. Disabil Rehabil Assist Technol, , 1–7.
Abstract: Purpose: Motor recovery of the upper limb (UL) is related to exercise intensity, defined as movement repetitions divided by minutes in active therapy, and task difficulty. However, the degree to which UL training in virtual reality (VR) applications deliver intense and challenging exercise and whether these factors are considered in different centres for people with different sensorimotor impairment levels is not evidenced. We determined if (1) a VR programme can deliver high UL exercise intensity in people with sub-acute stroke across different environments and (2) exercise intensity and difficulty differed among patients with different levels of UL sensorimotor impairment.Methods: Participants with sub-acute stroke (<6 months) with Fugl-Meyer scores ranging from 14 to 57, completed 10 approximately 50-min UL training sessions using three unilateral and one bilateral VR activity over 2 weeks in centres located in three countries. Training time, number of movement repetitions, and success rates were extracted from game activity logs. Exercise intensity was calculated for each participant, related to UL impairment, and compared between centres.Results: Exercise intensity was high and was progressed similarly in all centres. Participants had most difficulty with bilateral and lateral reaching activities. Exercise intensity was not, while success rate of only one unilateral activity was related to UL severity.Conclusion: The level of intensity attained with this VR exercise programme was higher than that reported in current stroke therapy practice. Although progression through different activity levels was similar between centres, clearer guidelines for exercise progression should be provided by the VR application.Implications for rehabilitationVR rehabilitation systems can be used to deliver intensive exercise programmes.VR rehabilitation systems need to be designed with measurable progressions through difficulty levels.
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