Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for a randomized controlled trial.

BACKGROUND: Stroke survivors have long-term upper limb impairment, which impacts the quality of life (QOL) and social reintegration, but there is lack of effective therapeutic strategies and novel technologies. Customized multi-muscle functional electrical stimulation (FES) based on the muscle synergy of healthy adults and robotic-assisted therapy (RAT) have been proved efficacy respectively. Synergy-based FES combined with RAT can be a novel and more effective therapy for upper limb recovery of stroke survivors from the perspective of synergistic enhancement. However, few studies have examined the effectiveness of combined synergy-based FES and RAT, especially for motor control evaluated by reach-to-grasp (RTG) movements. The main objective of the following research protocol is to evaluate the effectiveness and efficacy, as well as adoptability, of FES-RAT and FES or RAT rehabilitation program for upper limb function improvement after stroke. METHODS: This will be an assessor-blinded randomized controlled trial involving a 12-week intervention and a 6-month follow-up. Stratified randomization will be used to equally and randomly assign 162 stroke patients into the FES + conventional rehabilitation program (CRP) group, RAT + CRP group and FES-RAT + CRP group. Interventions will be provided in 5 sessions per week, with a total of 60 sessions. The primary outcome measurements will include the Fugl-Meyer Assessment and Biomechanical Assessment of RTG movements. The secondary outcome measurements will include quality of life and brain neuroplasticity assessments by MRI. Evaluations will be performed at five time points, including at baseline, 6 weeks and 12 weeks from the start of treatment, and 3 months and 6 months following the end of treatment. A two-way analysis of variance with repeated measures will be applied to examine the main effects of the group, the time factor and group-time interaction effects. DISCUSSION: The results of the study protocol will provide high quality evidence for integrated synergy-based FES and RAT, and synergy-based FES alone and guide the design of more effective treatment methods for stroke rehabilitation. TRIAL REGISTRATION: ChiCTR2300071588.

Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial.

BACKGROUND: Statistics show that every year, 5.4 million people in the world suffer a stroke. Post-stroke cognitive impairment (PSCI) is one of the most common complications after stroke with a rate of 75%, which leads to decreased functions for independent living and reduced quality of life (QOL). Exercise training has been reported to be useful to improve the cognitive functions of post-stroke patients. Yijinjing, a traditional Chinese Qigong exercise characterized by an integration of mind and body in moderate exercise intensity, can improve cognitive functions of PSCI patients. This study aims to explore the feasibility and effectiveness of the Yijinjing exercise in this regard. METHODS: A single-blind, superiority, randomized controlled trial will be employed with evaluations at 3 and 6 months. Seventy-two PSCI patients will be recruited and randomly assigned to the Yijinjing exercise intervention group or the control group (1:1). Participants in the control group will receive routine rehabilitation therapies, including occupational therapy, physical therapy, acupuncture therapy, and health education 5 times a week for 3 months. The intervention group will receive a 12-week routine rehabilitation therapy combined with the Yijinjing exercise intervention for 40 min each session and 3 sessions a week. The primary outcome of cognition will be measured by the Montreal Cognitive Assessment scale (MoCA). Secondary outcomes include executive function, memory function, visuospatial function, sleep quality, gait and motor function, activity of daily living (ADL), and quality of life (QOL). DISCUSSION: Current evidence has reported the effectiveness of traditional Chinese exercise in improving the post-stroke population's motor functions. This research is a randomized controlled trial that evaluates traditional Chinese exercise's effectiveness for PSCI patients. It is expected to expand the traditional Chinese exercise scope and provide a new treatment approach for stroke populations with cognitive impairments. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026532 . Registered on 13 October 2019.

[Chronic effects on the prevention of atrial fibrillation recurrence in patients with lone paroxysmal atrial fibrillation treated with amiodarone, segmental pulmonary vein ablation, or amiodarone plus losartan: a prospective cohort study].

OBJECTIVE: This study was designed to compare clinical efficacy of segmental pulmonary vein ablation (SPVI), amiodarone or amiodarone plus losartan on sinus rhythm maintenance in patients with lone paroxysmal atrial fibrillation (PAF). METHODS: Patients with lone PAF were treated with amiodarone alone (A, n = 52), segmental pulmonary vein isolation (SPVI, n = 51), or amiodarone plus losartan (AL, n = 51). The primary endpoint of this study was the incidence of symptomatic atrial tachyarrhythmia (> 30 s) documented by 12 lead ECG or Holter during 12 months follow-up period. RESULTS: During follow-up, AF was documented in 24 patients (46.2%) in A group, 11 patients (21.6%) in SPVI group and 12 (23.5%) in AL group (P < 0.05 vs. A group). The Kaplan-Meier survival analysis demonstrated a significant equally reduction in AF recurrence in SPVI and AL groups (P = 0.009, log-rank test and P = 0.018, log-rank test, respectively) compared with A group. The hazard ratio for AF recurrence in patients treated with SPVI and amiodarone plus losartan was 0.41 (95% CI 0.200 to 0.848, P = 0.016) and 0.46 (95% CI 0.225 to 0.953, P = 0.036), respectively. Incidences of major adverse cardiac events were similar among the groups (9.6% in A, 3.9% in SPVI and 7.8% in AL group, P > 0.05). CONCLUSION: The results of this study suggest that the segmental pulmonary vein isolation and amiodarone plus losartan are superior to amiodarone alone for preventing AF recurrence in patients with lone PAF.

[Relationship between body mass index, waist circumference and blood pressure among 5246 residents in Chongqing area].

OBJECTIVE: To explore the relationship between body mass index, waist circumference and blood pressure among residents in Chongqing area. METHODS: A total of 5246 residents aged 15 and over in Chongqing area were enrolled in this study by use of stratified sampling and cluster sampling methods. Data on blood pressure (SBP, DBP), pulse, height, body weight, waist and hip circumferences as well as questionnaire survey were analyzed. RESULTS: The level of SBP and DBP and hypertension prevalence rate were significantly positively correlated with BMI (all P < 0.01). SBP, DBP levels and hypertension prevalence rate were significantly higher in people with abdomen obesity than people with normal waist circumference (all P < 0.01). BMI, waist circumference in hypertensive residents were significantly higher than non-hypertensive residents (all P < 0.01). CONCLUSION: Blood pressure level and hypertension prevalence rate were closely related with BMI and waist circumference among residents in Chongqing area.

[Long-term clinical efficacy of losartan or perindopril combination therapy with low-dose amiodarone in patients with paroxysmal atrial fibrillation].

OBJECTIVE: The purpose of the present study was to evaluate the clinical efficacy of perindopril or losartan in combination with low-dose amiodarone on maintenance of sinus rhythm in patients with idiopathic paroxysmal atrial fibrillation (PAF). METHODS: One hundred and eighty-one patients with idiopathic PAF were included in the study and randomly divided into three groups: group 1 (amiodarone group, n = 61) was treated with amiodarone alone, group 2 (amiodarone plus losartan, n = 59) was treated with amiodarone and perindopril in combination, and group 3 (amiodarone plus perindopril group, n = 61) was treated with amiodarone and perindopril in combination. The left atrial diameter (LAD) was measured with transthoracic echocardiogram at before and after 6, 12, 18 and 24-month of treatment. The duration of observation was up to two years and the primary end point of the study was the first recurrence of AF. RESULTS: During the 6 month following up, there was no difference in LAD among the three groups. After 12 months, LAD in group 1 was significantly larger than group 2 and group 3 (P < 0.05). At 7th-month, the sinus rhythm maintenance of group 1 was lower significantly than group 2 and group 3. At the end of the study, the maintenance of sinus rhythm in group 2 and group 3 was higher significantly than in group 1 (83.05% and 80.33% vs 59.01%, P < 0.05), nevertheless, there was no significant difference between group 2 and group 3. CONCLUSIONS: The results of this study suggest that the combination of amiodarone with angiotensin converting enzyme inhibitor perindopril or with angiotensin II receptor antagonist losartan are more effective than amiodarone alone in sinus rhythm maintenance for idiopathic PAF. ACEI and ARB can inhibit the enlargement of left atrium and reduce recurrence rate in patients with idiopathic PAF.