Background: The Wolf Motor Function Test (WMFT) evaluates the upper limb (UL) performance of adults with hemiparesis by combining
Single sessions of PSS + tDCS, tDCS alone, or RPSS alone did not improve training effects in chronic stroke patients with moderate to severe impairment.
Background: Repetitive peripheral nerve sensory stimulation (RPSS) has emerged as a potential adjuvant strategy to motor training in stroke rehabilitation. The aim of this study is to test the hypothesis that 3 h sessions of active RPSS associated with functional electrical stimulation (FES) and task-specific training (TST) distributed three times a week, over 6 weeks, is more beneficial to improve upper limb motor function than sham RPSS in addition to FES and TST, in subjects with moderate to severe hand motor impairments in the chronic phase (>6 months) after stroke. Methods: In this single-center, randomized, placebo controlled, parallel-group, double-blind study we compare the effects of 18 sessions of active and sham RPSS as add-on interventions to FES and task-specific training of the paretic upper limb, in 40 subjects in the chronic phase after ischemic or hemorrhagic stroke, with Fugl-Meyer upper limb scores ranging from 7 to 50 and able to voluntarily activate any active range of wrist extension. The primary outcome measure is the Wolf Motor Function Test (WMFT) after 6 weeks of treatment. The secondary outcomes are the WMFT at 3, 10, and 18 weeks after beginning of treatment, as well as the following outcomes measured at 3, 6, 10, and 18 weeks: Motor Activity Log; active range of motion of wrist extension and flexion; grasp and pinch strength in the paretic and non-paretic sides (the order of testing is randomized within and across subjects); Modified Ashworth Scale; Fugl-Meyer Assessment-Upper Limb in the paretic arm; Barthel Index; Stroke Impact Scale. Discussion: This project represents a major step in developing a rehabilitation strategy with potential to have impact on the treatment of stroke patients with poor Conforto et al. Nerve Stimulation in Stroke motor recovery in developing countries worldwide. The study preliminarily evaluates a straightforward, non-invasive, inexpensive intervention. If feasibility and preliminary efficacy are demonstrated, further investigations of the proposed intervention (underlying mechanisms/ effects in larger numbers of patients) should be performed. Trial Registration: 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
Introduction: Transcranial direct current stimulation (tDCS) and somatosensory stimulation in the form of peripheral sensory stimulation (PSS) have emerged as potential powerful tools to enhance motor performance or increase effects of motor training in stroke victims. Objectives: To compare effects of active PSS+tDCS, tDCS alone, PSS alone and sham PSS+tDCS as add-on interventions to motor training in patients with stroke and moderate to severe upper limb impairments. Methods: Patients > 6 months post-stroke underwent four different interventions, in a cross-over design: repetitive training of wrist extension of the paretic arm preceded by either active PSS (median, ulnar and radial nerves), active anodal tDCS of the affected hemisphere, sham PSS+tDCS or active PSS+tDCS. Before and after each session, the following outcomes were blindly evaluated in the paretic upper limb: range of movement (ROM) of wrist extension (primary outcome); ROM of wrist flexion, grasp and pinch strength. Measures were compared with analysis of variance with repeated measures (ANOVARM) with factors “session” and “time”. Results: After screening 2499 patients, 22 subjects were included in the study (14 men). The mean age (± standard deviation) was 55.2±12.9 years and the mean time from stroke, 5.3±5.6 years. The mean Fugl-Meyer score for the paretic upper limb was 37±7.9. Two patients were excluded (one dropped out and one received botulinum toxin treatment). There was a significant effect of “time” (F=4.6, p=0.046), but no effects of “session” or interaction “session x time” in regard to grasp force. There were no significant effects of “session”, “time” or interaction “session x time” in regard to ROM of wrist extension, wrist flexion, or pinch force. Conclusions: Repetitive training of wrist extension specifically improved grasp force and did not influence other outcomes. PSS+tDCS, tDCS alone or PSS alone did not potentiate the effect of training.
Background: Repetitive peripheral sensory stimulation (RPSS) followed by 4- hour task-specific training improves upper limb motor function in subjects with stroke who experience moderate to severe motor upper limb impairments. Obectives: Here, we compared effects of RPSS versus sham followed by a shorter duration of training in subjects with moderate to severe motor impairments in the chronic phase after stroke. Design and setting: Single-center, randomized, placebo-controlled, parallelgroup clinical trial. Methods: We compared effects of 18 sessions of either 1.5 hours of active RPSS or sham followed by a supervised session of 30-minutes of functional electrical stimulation (FES) and 45-minutes of task-specific training (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 six 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: RPSS enhanced hand strength in chronic stroke. Despite the short duration of supervised training (2.75 hours/session), changes in WMFT in both groups were comparable to those reported after longer, more intensive training protocols. These findings are relevant to settings that impose constraints in duration of direct contact between therapists and patients.
Introduction: Peripheral sensory stimulation (PSS) administered for 2 hours prior to intensive task-oriented motor training delivered for 4 hours, over 10 days, leads to clinically significant benefits in subjects with stroke and moderate to severe upper limb motor impairment, compared to sham PSS. Whether similar results can be obtained with less intensive training programs remains to be determined. Methods: Twenty subjects with stroke in the chronic phase (>6m) and moderate to severe upper limb motor impairments were randomized to treatment with either 1.5h active PSS or sham, followed by functional electrical stimulation (FES) and task-specific training (TST) in sessions administered three times per week over six weeks. FES lasted for 30 minutes and TST, for 45 minutes. The primary outcome was the difference in performance in the Wolf Motor Function Test. The data were analyzed with a generalized estimating equations model with factors “group” (active or sham) and “time” (baseline, three and six weeks after starting treatment). Results: There were significant effects of “time” (Wald Chi-square = 16.5, p<0.001) and interaction between “group” and “time” (Wald Chi-square = 10.4, p=0.005) for the Wolf Motor Function Test, Functional Ability Scale. Post-hoc Bonferroni-corrected analyses showed a statistically significant improvement in performance between baseline and three weeks after beginning of treatment in the active (p=0.001) but not in the sham group (p=0.912). The difference between performance at baseline and six weeks after beginning of treatment almost reached statistically significance in the active (p=0.058) but not in the sham (p>0.999) group. Conclusions: These results are relevant for the design of larger clinical trials involving durations of interventions that are more easily implemented in clinical practice than rehabilitation protocols lasting for 6 hours per day. The study is ongoing.
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