Gothenburg Very Early Supported Discharge study (GOTVED): a randomised controlled trial investigating anxiety and overall disability in the first year after stroke

Abstract Background and purpose Early supported discharge (ESD) has been shown to be efficient and safe as part of the stroke care pathway. The best results have been seen with a multidisciplinary team and after mild to moderate stroke. However, how very early supported discharge (VESD) works has not been studied. The aim of this study was to investigate whether VESD for stroke patients in need of ongoing individualized rehabilitation affects the level of anxiety and overall disability for the patient compared with ordinary discharge routine. Methods A randomized controlled trial was performed with intention to treat analyses comparing VESD and ordinary discharge from hospital. All patients admitted at the stroke care unit at Sahlgrenska University Hospital of Gothenburg between August 2011 and April 2016 were screened. Inclusion occurred on day 4 using a block randomization of 20 and with a blinded assessor. Assessments were made 5 days post-stroke and 3 and 12 months post-stroke. Patients in the VESD group underwent continued rehabilitation in their homes with a multidisciplinary team from the stroke care unit for a maximum of 1 month. The patients in the control group had support as usual after discharge when needed such as home care service and outpatient rehabilitation. The primary outcome was anxiety as assessed by the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The secondary outcome was the patients’ degree of overall disability, measured by the modified Rankin Scale (mRS). Results No significant differences were found between the groups regarding anxiety at three or 12 months post-stroke (p = 0.811). The overall disability was significantly lower in the VESD group 3 months post-stroke (p = 0.004), compared to the control group. However, there was no significant difference between the groups 1 year post-stroke. Conclusions The VESD does not affects the level of anxiety compared to ordinary rehabilitation. The VESD leads to a faster improvement of overall disability compared to ordinary rehabilitation. We suggest considering coordinated VESD for patients with mild to moderate stroke in addition to ordinary rehabilitation as part of the service from a stroke unit. Trial registration Clinical Trials.gov: NCT01622205. Registered 19 June 2012 (retrospectively registered).

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A Chinese Herbal Medicine, Tokishakuyakusan, Reduces the Worsening of Impairments and Independence after Stroke: A 1-Year Randomized, Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1093/ecam/nep026 ◽

2011 ◽

Vol 2011 ◽

pp. 1-6 ◽

Cited By ~ 14

Author(s):

Hirozo Goto ◽

Nobuhiko Satoh ◽

Yoshinori Hayashi ◽

Hiroaki Hikiami ◽

Yutaka Nagata ◽

...

Keyword(s):

Herbal Medicine ◽

Controlled Trial ◽

Strength Function ◽

Functional Independence ◽

Lower Limbs ◽

Favorable Effect ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Significant Difference

In post-stroke patients, the recurrence of stroke and progression of impairments lead to a bedridden state and dementia. As for their treatments, only anti-hypertension and anti-coagulation therapies to prevent the recurrence of stroke are available. In Asia, post-stroke patients with impairments are often treated with herbal medicine. The present study evaluated the effectiveness of tokishakuyakusan (TS) in improving the impairment and independence in post-stroke patients. Thirty-one post-stroke patients (mean age = 81.4 years) were recruited and enrolled. Participants were randomly assigned to the TS group (n= 16) or non-treatment (control) group (n= 15) and treated for 12 months. Impairments were assessed using the Stroke Impairment Assessment Set (SIAS). Independence was evaluated using the functional independence measure (FIM). For each outcome measure, mean change was calculated every 3 months. The results were that impairments according to SIAS did not significantly change in the TS group. In contrast, SIAS significantly worsened in the control group. There was a significant difference between the two groups. In each term of SIAS, affected lower extremity scores, abdominal muscle strength, function of visuospatial perception, and so forth. in the TS group were better than those in the control group. Independence according to FIM did not change significantly in the TS group. In contrast, FIM significantly worsened in the control group. There was also a significant difference between the two groups. In conclusion, TS was considered to suppress the impairments of lower limbs and to exert a favorable effect on cerebral function for post-stroke patients.

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Efficacy and Safety of Intravenous Mesenchymal Stem Cells for Ischemic Stroke

Neurology ◽

10.1212/wnl.0000000000011440 ◽

2021 ◽

pp. 10.1212/WNL.0000000000011440

Author(s):

Jong-Won Chung ◽

Won Hyuk Chang ◽

Oh Young Bang ◽

Gyeong Joon Moon ◽

Suk Jae Kim ◽

...

Keyword(s):

Stem Cells ◽

Mesenchymal Stem Cells ◽

Controlled Trial ◽

Outcome Evaluation ◽

Autologous Serum ◽

Secondary Outcome ◽

Control Group ◽

Link Type ◽

Significant Difference ◽

Major Stroke

ObjectiveTo test whether autologous modified mesenchymal stem cells (MSCs) improve recovery in patients with chronic major stroke.MethodsIn this prospective, open-label, randomized controlled trial with blinded outcome evaluation, patients with severe middle cerebral artery territory infarct within 90 days of symptom onset were assigned, in a 2:1 ratio, to receive preconditioned autologous MSC injections (MSC group) or standard treatment alone (control group). The primary outcome was the score on the modified Rankin Scale (mRS) at 3 months. The secondary outcome was to further demonstrate motor recovery.ResultsA total of 39 and 15 patients were included in the MSC and control groups, respectively, for the final intention-to-treat analysis. Mean age of patients was 68 (range, 28–83) years, and mean interval between stroke onset to randomization was 20.2 (range, 5–89) days. Baseline characteristics were not different between groups. There was no significant difference between the groups in the mRS score shift at 3 months (p = 0.732). However, secondary analyses showed significant improvements in lower extremity motor function in the MSC group compared to the control group (change in the leg score of the Motricity Index, p = 0.023), which was notable among patients with low predicted recovery potential. There were no serious, treatment-related adverse events.ConclusionsIntravenous application of preconditioned, autologous MSCs with autologous serum was feasible and safe in patients with chronic major stroke. MSC treatment was not associated with improvements in the 3-month mRS score, but we did observe leg motor improvement in detailed functional analyses.Classification of evidenceThis study provides Class III evidence that autologous mesenchymal stem cells do not improve 90-day outcomes in patients with chronic stroke.Trial registrationclinicaltrials.gov Identifier: NCT01716481.

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Randomized Controlled Trial of Probiotic PS128 in Children with Tourette Syndrome

Nutrients ◽

10.3390/nu13113698 ◽

2021 ◽

Vol 13 (11) ◽

pp. 3698

Author(s):

Chang-Chun Wu ◽

Lee-Chin Wong ◽

Chia-Jui Hsu ◽

Chianne-Wen Yang ◽

Ying-Chieh Tsai ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Tourette Syndrome ◽

Performance Test ◽

Controlled Trial ◽

Continuous Performance Test ◽

Secondary Outcome ◽

Control Group ◽

Randomized Controlled ◽

Significant Difference ◽

Social Environmental

Tourette syndrome results from a complex interaction between social–environmental factors, multiple genetic abnormalities, and neurotransmitter disturbances. This study is a double-blinded, randomized controlled trial using probiotics Lactobacillus plantarum PS128 as an intervention to examine if probiotics improve symptoms of children with Tourette syndrome. This study enrolled children aged 5 to 18 years old who fulfilled DSM-V diagnostic criteria for Tourette syndrome. Patients were assessed before initiating the trial, at one month, and at two months after randomization. The primary outcome was evaluated by Yale Global Tic Severity Scale (YGTSS), and the secondary outcome studied the possible comorbidities in these children. The results revealed no significant difference in improvement in YGTSS between the control group and the PS128 group. As for secondary endpoints, an analysis of Conners’ Continuous Performance Test (CPT) showed improvement in commission and detectability in the PS128 group. In conclusion, although probiotics may not have tic-reducing effects in children with Tourette syndrome, it may have benefits on comorbidities such as attention deficit and hyperactivity disorder (ADHD). Further studies are needed to clarify the effects of probiotics on the comorbidities of Tourette syndrome children.

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Does Nursery-Based Intensified Anticipatory Guidance Reduce Emergency Department Use for Nonurgent Conditions in the First Month of Life? A Randomized Controlled Trial

International Journal of Pediatrics ◽

10.1155/2016/8356582 ◽

2016 ◽

Vol 2016 ◽

pp. 1-6

Author(s):

Kelly Kamimura-Nishimura ◽

Vikram Chaudhary ◽

Folake Olaosebikan ◽

Maryam Azizi ◽

Sneha Galiveeti ◽

...

Keyword(s):

Emergency Department ◽

Controlled Trial ◽

Intervention Group ◽

Newborn Care ◽

Secondary Outcome ◽

Control Group ◽

Anticipatory Guidance ◽

Guidance Program ◽

Significant Difference ◽

The Impact

Objective.We aimed to evaluate the impact of an intensified anticipatory guidance program in the nursery on Emergency Department (ED) use for nonurgent conditions (NUCs) in the neonatal period.Methods. Parturient mothers of healthy newborns were randomized to an intervention group or control group. Baseline and 1-month follow-up knowledge surveys regarding newborn care were conducted. The primary outcome was the proportion of neonates who used the ED for a NUC. Secondary outcome was change in caregivers’ knowledge on NUC.Results. Of a total of 594 mothers, 323 (54%) agreed to participate and were randomized to intervention (n=170) or control (n=153) group. Most were Hispanic (68%), single (61%), primiparous (39%), and without high school diploma (44%). 35 (21%) neonates in the intervention group and 41 (27%) in the control group were brought at least once for a NUC to the ED (p=0.12). There was no statistically significant difference in within subject change on knowledge scores between the two study arms.Conclusions. Neonatal ED visits for NUCs occur frequently. This nursery-based intensified anticipatory guidance program had no statistically significant impact on neonatal ED use for NUC, nor on neonatal care-relevant knowledge among parturient mothers. Alternative modalities and timing of parental educational intervention may need to be considered. This trial is registered with Clinical Trials NumberNCT01859065(Clinicaltrials.gov).

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Efficacy of a Novel Exoskeletal Robot for Locomotor Rehabilitation in Stroke Patients: A Multi-center, Non-inferiority, Randomized Controlled Trial

Frontiers in Aging Neuroscience ◽

10.3389/fnagi.2021.706569 ◽

2021 ◽

Vol 13 ◽

Author(s):

Yongqiang Li ◽

Tao Fan ◽

Qi Qi ◽

Jun Wang ◽

Huaide Qiu ◽

...

Keyword(s):

Lower Limb ◽

Controlled Trial ◽

Swing Phase ◽

Control Group ◽

Locomotor Training ◽

Stroke Patients ◽

Locomotor Function ◽

Subacute Stroke ◽

Significant Difference ◽

Robot Group

Objective: To investigate the efficacy and safety of a novel lower-limb exoskeletal robot, BEAR-H1 (Shenzhen Milebot Robot Technology), in the locomotor function of subacute stroke patients.Methods: The present study was approved by the ethical committee of the First Affiliated Hospital of Nanjing Medical University (No. 2019-MD-43), and registration was recorded on the Chinese Clinical Trial Registry with a unique identifier: ChiCTR2100044475. A total of 130 patients within 6 months of stroke were randomly divided into two groups: the robot group and the control group. The control group received routine training for walking, while in the robot group, BEAR-H1 lower-limb exoskeletal robot was used for locomotor training. Both groups received two sessions daily, 5 days a week for 4 weeks consecutively. Each session lasted 30 min. Before treatment, after treatment for 2 weeks, and 4 weeks, the patients were assessed based on the 6-minute walking test (6MWT), functional ambulation scale (FAC), Fugl-Meyer assessment lower-limb subscale (FMA-LE), and Vicon gait analysis.Results: After a 4-week intervention, the results of 6MWT, FMA-LE, FAC, cadence, and gait cycle in the two groups significantly improved (P < 0.05), but there was no significant difference between the two groups (P > 0.05). The ratio of stance phase to that of swing phase, swing phase symmetry ratio (SPSR), and step length symmetry ratio (SLSR) was not significantly improved after 4 weeks of training in both the groups. Further analyses revealed that the robot group exhibited potential benefits, as the point estimates of 6MWT and Δ6MWT (post-pre) at 4 weeks were higher than those in the control group. Additionally, within-group comparison showed that patients in the robot group had a significant improvement in 6MWT earlier than their counterparts in the control group.Conclusions: The rehabilitation robot in this study could improve the locomotor function of stroke patients; however, its effect was no better than conventional locomotor training.

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Effectiveness of Yijinjing on Cognitive Functions in Post-stroke Patients With Mild Cognitive Impairment: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-204458/v1 ◽

2021 ◽

Author(s):

Xin Xue ◽

Xue-Xing Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract 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, randomized controlled trial will be employed with evaluations at three and six months. 72 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 minutes 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.Trail registration: Chinese Clinical Trial Registry, ChiCTR1900026532. Registered on 13 October 2019.

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The efficiency of combining modified acupuncture and motor relearning method on post-stroke patients

MedPharmRes ◽

10.32895/ump.mpr.3.1.17 ◽

2019 ◽

Vol 3 (1) ◽

pp. 17-21

Author(s):

Man Bui ◽

Dan Nguyen ◽

Nam Thai ◽

Thuong Trinh

Keyword(s):

Traditional Medicine ◽

Motor Deficit ◽

Military Hospital ◽

Control Group ◽

Trial Group ◽

Stroke Patients ◽

Post Stroke ◽

Significant Difference ◽

Multicenter Randomized Controlled Trial ◽

Barthel Score

Background and Objectives: Combining modern medicine and traditional medicine in the rehabilitation of post-stroke motor deficit has shown interesting results. Many studies on modified acupuncture, a combination of modern and traditional techniques, have proven its effectiveness in motor rehabilitation in post-stroke patients. Furthermore, the effectiveness of the motor relearning method in the treatment of post-stroke paralysis has been elucidated. Therefore, our study aims to determine whether the combination between modified acupuncture and motor relearning method can improve treatment outcomes. Method: Multicenter randomized controlled trial (Traditional Medicine Hospital of Ho Chi Minh City, General Hospital of Soc Trang Province, and People Military Hospital of Soc Trang Province) from July 2014 to July 2015. 66 post-stroke patients were divided into two groups: The control group received modified acupuncture combined with Bobath method and the trial group received modified acupuncture combined with motor relearning method. After six weeks, patients were evaluated according to the Barthel score, the 10-hole test, and the ability to walk. Results: The trial group showed better results than the control group. There was a significant difference between the two groups in the Barthel score and the ability to walk, excluding the 10-hole test. After treatment, 77.42% of patients in the trial group showed improvement compared to only 51.61% in the control group (P < 0.05). Conclusion: The combination of modified acupuncture and motor relearning method is more effective than the combination of modified acupuncture and Bobath method in the rehabilitation of motor deficit after stroke.

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

Trials ◽

10.1186/s13063-021-05220-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Xin Xue ◽

Xue-Ming Jin ◽

Kai-Liang Luo ◽

Xin-Hao Liu ◽

Li Zhang ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Functions ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Stroke Patients ◽

Post Stroke ◽

Randomized Controlled

Abstract 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.

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Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial

Biology ◽

10.3390/biology10111187 ◽

2021 ◽

Vol 10 (11) ◽

pp. 1187

Author(s):

Jie Wang ◽

Lei Qiao ◽

Long Yu ◽

Yanmin Wang ◽

Redha Taiar ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Stance Phase ◽

Controlled Trial ◽

Weight Bearing ◽

Gait Training ◽

Secondary Outcome ◽

Control Group ◽

Stroke Patients ◽

Randomized Controlled ◽

Experimental Group

Background: Insoles have been widely applied to many diseases, but stroke involves complex problems and there is a paucity of research on the application of insoles in stroke patients. Aim: To evaluate the effect of customized insoles on gait in patients with hemiplegia. Design: A randomized controlled trial. Setting: Rehabilitation department of a hospital. Population: A total of 50 stroke patients were randomized into an experimental group (n = 25) or a control group (n = 25). Methods: Both groups received conventional gait training, which was conducted five times a week, every 40 min for four weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for four weeks. The primary outcome measure was the Tinetti Gait Scale (TGS) and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), lower extremity Fugl–Meyer assessment (FMA-LE), Berg Balance Scale (BBS), and the modified Barthel index (MBI). Results: Compared to the control group, there were significant increases in the experimental group after four weeks (p = 0.014) and at the four week follow-up (p = 0.001) in the change in TGS, weight-bearing on the involved side (p = 0.012) or forefoot (p = 0.028) when standing, weight-bearing on the involved side (p = 0.01 6) or forefoot (p = 0.043) when walking, early stance phase (p = 0.023) and mid stance phase (p = 0.013) on the involved side, FMA-LE (p = 0.029), BBS (p = 0.005), and MBI (p = 0.009), but there were no differences in the late stance phase (p = 0.472) on the involved side when walking or in the 6MWT (p = 0.069). Conclusions: Customized insoles had great efficacy in enhancing gait performance in stroke patients.

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ID: 1019 Efficiency of the combination of modified acupuncture and motor relearning method in post-stroke patients

Biomedical Research and Therapy ◽

10.15419/bmrat.v4is.297 ◽

2017 ◽

Vol 4 (S) ◽

pp. 94

Author(s):

Bui Pham Minh Man ◽

Thuong Trinh Thi Dieu

Keyword(s):

Traditional Medicine ◽

Motor Deficit ◽

Control Group ◽

Trial Group ◽

Walk Test ◽

Stroke Patients ◽

Post Stroke ◽

Significant Difference ◽

Barthel Score ◽

10 Meter Walk Test

Background and Objectives: The combination of modern medicine and traditional medicine in the rehabilitation of motor deficit after stroke has shown interesting results. Many studies on modified acupuncture, a combination of modern and traditional techniques, have proven its effectiveness in motor rehabilitation in post-stroke patients. Furthermore, many studies have elucidated the effectiveness of the motor relearning method in the treatment of post-stroke paralysis. Therefore, this study aims to determine whether the combination of modified acupuncture and motor relearning method can improve the treatment results. Method: Multi-centered randomized controlled trial (Traditional Medicine Hospital of Ho Chi Minh City, General Hospital of Soc Trang Province, and People Military Hospital of Soc Trang Province) from July 2014 to July 2015. 66 post-stroke patients were divided into two groups: a control group received modified acupuncture combined with Bobath method and a trial group received modified acupuncture combined with motor relearning method. After six weeks, patients were evaluated according to the Barthel score, 10-hole test, and 10-meter-walk test. Results: The trial group showed better results than the control group did. There was a significant difference between two groups in Barthel score and 10-meter-walk test, but not in the 10-hole test. After treatment, 77.42% patients of the trial group showed improvement while only there are 51.61% in the other group (P < 0.05). Conclusion: The combination of modified acupuncture and motor relearning method is more effective than the combination of modified acupuncture and Bobath method in the rehabilitation of motor deficit after stroke.

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