Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial
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-invasi...
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doaj-12842af28a964a4c83444c47fa0f86962020-11-25T01:20:10ZengBMCTrials1745-62152018-01-011911910.1186/s13063-017-2377-6Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trialMindy F. Levin0Melanie C. Baniña1Silvi Frenkel-Toledo2Sigal Berman3Nachum Soroker4John M. Solomon5Dario G. Liebermann6School of Physical and Occupational Therapy, Faculty of Medicine, McGill UniversitySchool of Physical and Occupational Therapy, Faculty of Medicine, McGill UniversityDepartment of Physical Therapy, Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv UniversityDepartment of Industrial Engineering and Management, Ben-Gurion University of the NegevDepartment of Neurological Rehabilitation, Loewenstein HospitalDepartment of Physiotherapy, School of Allied Health Sciences (SOAHS), Manipal UniversityDepartment of Physical Therapy, Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv UniversityAbstract 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.http://link.springer.com/article/10.1186/s13063-017-2377-6StrokeSpasticitySpatial thresholdtDCSNeurorehabilitation |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Mindy F. Levin Melanie C. Baniña Silvi Frenkel-Toledo Sigal Berman Nachum Soroker John M. Solomon Dario G. Liebermann |
spellingShingle |
Mindy F. Levin Melanie C. Baniña Silvi Frenkel-Toledo Sigal Berman Nachum Soroker John M. Solomon Dario G. Liebermann Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial Trials Stroke Spasticity Spatial threshold tDCS Neurorehabilitation |
author_facet |
Mindy F. Levin Melanie C. Baniña Silvi Frenkel-Toledo Sigal Berman Nachum Soroker John M. Solomon Dario G. Liebermann |
author_sort |
Mindy F. Levin |
title |
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
title_short |
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
title_full |
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
title_fullStr |
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
title_full_unstemmed |
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
title_sort |
personalized upper limb training combined with anodal-tdcs for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2018-01-01 |
description |
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. |
topic |
Stroke Spasticity Spatial threshold tDCS Neurorehabilitation |
url |
http://link.springer.com/article/10.1186/s13063-017-2377-6 |
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