Adriana B Conforto1,2,3, André G Machado4,5, Nathalia H V Ribeiro1, Ela B Plow4,5, Sook-Lei Liew6, Claudia da Costa Leite3,7, Artemis Zavaliangos-Petropulu6, Isabella Menezes1, Sarah M Dos Anjos8, Rafael Luccas1, Paul Hunter Peckham9, Leonardo G Cohen10. 1. Neurology Clinical Division, Hospital Das Clínicas, 117265São Paulo University and Fundação Faculdade de Medicina, São Paulo, Brazil. 2. Hospital Israelita Albert Einstein, São Paulo, Brazil. 3. Núcleo de Apoio à Pesquisa Em Neurociências (Center for Interdisciplinary Research on Applied Neurosciences: NAPNA), São Paulo University, São Paulo, Brazil. 4. Departament of Neurosciences, 2569Lerner Reasearch Institute, Cleveland Clinic, Cleveland, OH, USA. 5. 2546Case Western Reserve University, Cleveland, OH, USA. 6. Chan Division of Occupational Science and Occupational Therapy, Biokinesiology and Physical Therapy, Biomedical Engineering, and Neurology; USC Stevens Neuroimaging and Informatics Institute, 5116University of Southern California, Los Angeles, CA, USA. 7. LIM 44. Department of Radiology of Oncology, 37884Faculdade de Medicina, Hospital Das Clínicas/São Paulo University, São Paulo, Brazil. 8. School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, USA. 9. MetroHealth Medical Center, Cleveland, OH, USA. 10. Human Cortical Physiology and Stroke Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
Abstract
INTRODUCTION: Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST) improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Here, we compared effects of RPSS vs sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke. METHODS: This single-center, randomized, placebo-controlled, parallel-group clinical trial compared effects of 18 sessions of either 1.5 h of active RPSS or sham followed by a supervised session that included 45 min of TST of the paretic upper limb. In both groups, subjects were instructed to perform functional tasks at home, without supervision. The primary outcome measure was the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. Grasp and pinch strength were secondary outcomes. RESULTS: In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment. Grasp strength improved significantly in the active, but not in the sham group, at 3 and 6 weeks. Pinch strength improved significantly in both groups at 3 weeks, and only in the active group at 6 weeks. CONCLUSIONS: The between-group difference in changes in WMFT was not statistically significant. Despite the short duration of supervised treatment, WMFT improved significantly in subjects treated with RPSS or sham. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients. In addition, RPSS led to significant gains in hand strength.Trial Registry Name: Peripheral Nerve Stimulation and Motor Training in Stroke Clinical Trials.gov identifier: NCT0265878 https://clinicaltrials.gov/ct2/show/NCT02658578.
INTRODUCTION: Repetitive peripheral sensory stimulation (RPSS) followed by 4-hour task-specific training (TST) improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Here, we compared effects of RPSS vs sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke. METHODS: This single-center, randomized, placebo-controlled, parallel-group clinical trial compared effects of 18 sessions of either 1.5 h of active RPSS or sham followed by a supervised session that included 45 min of TST of the paretic upper limb. In both groups, subjects were instructed to perform functional tasks at home, without supervision. The primary outcome measure was the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. Grasp and pinch strength were secondary outcomes. RESULTS: In intention-to-treat analysis, WMFT improved significantly in both active and sham groups at 3 and 6 weeks of treatment. Grasp strength improved significantly in the active, but not in the sham group, at 3 and 6 weeks. Pinch strength improved significantly in both groups at 3 weeks, and only in the active group at 6 weeks. CONCLUSIONS: The between-group difference in changes in WMFT was not statistically significant. Despite the short duration of supervised treatment, WMFT improved significantly in subjects treated with RPSS or sham. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients. In addition, RPSS led to significant gains in hand strength.Trial Registry Name: Peripheral Nerve Stimulation and Motor Training in Stroke Clinical Trials.gov identifier: NCT0265878 https://clinicaltrials.gov/ct2/show/NCT02658578.
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