Mindy F Levin1,2,3, Melanie C Baniña4,5, Silvi Frenkel-Toledo6,7, Sigal Berman8, Nachum Soroker7,9, John M Solomon10, Dario G Liebermann6. 1. School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, QC, Canada. mindy.levin@mcgill.ca. 2. Center for Interdisciplinary Research in Rehabilitation (CRIR), Montreal, QC, Canada. mindy.levin@mcgill.ca. 3. School of Physical and Occupational Therapy, McGill University, 3654 Promenade Sir William Osler, Montreal, QC, H3S 1Y5, Canada. mindy.levin@mcgill.ca. 4. School of Physical and Occupational Therapy, Faculty of Medicine, McGill University, Montreal, QC, Canada. 5. Center for Interdisciplinary Research in Rehabilitation (CRIR), Montreal, QC, Canada. 6. Department of Physical Therapy, Stanley Steyer School of Health Professions, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 7. Department of Neurological Rehabilitation, Loewenstein Hospital, Ra'anana, Israel. 8. Department of Industrial Engineering and Management, Ben-Gurion University of the Negev, Beer-Sheva, Israel. 9. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 10. Department of Physiotherapy, School of Allied Health Sciences (SOAHS), Manipal University, Manipal, Karnataka, India.
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.
RCT Entities:
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.
Authors: An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher Journal: BMJ Date: 2013-01-08
Authors: C Gowland; P Stratford; M Ward; J Moreland; W Torresin; S Van Hullenaar; J Sanford; S Barreca; B Vanspall; N Plews Journal: Stroke Date: 1993-01 Impact factor: 7.914
Authors: Andrés Molero-Chamizo; Ángeles Salas Sánchez; Belén Álvarez Batista; Carlos Cordero García; Rafael Andújar Barroso; G Nathzidy Rivera-Urbina; Michael A Nitsche; José R Alameda Bailén Journal: Front Pharmacol Date: 2021-04-21 Impact factor: 5.810