• Title/Summary/Keyword: non-randomized controlled trial

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The effect of treadmill gait training with patellar taping on gait abilities in chronic stroke patients

  • Shin, Jin;Chung, Yijung
    • Physical Therapy Rehabilitation Science
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    • v.4 no.2
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    • pp.94-102
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    • 2015
  • Objective: The purpose of this study is to investigate the effect of treadmill gait training with patellar taping on gait abilities in chronic stroke patients. Design: Randomized controlled trial. Methods: Thirty chronic stroke patients who have been diagnosed at least six months or before were recruited in Gyeongin Rehabilitation Center Hospital, located in Incheon. Patients who were enrolled in this study were randomized to experimental group (n=15) or control group (n=15). Treadmill with patella taping training group patients were applied with patellar taping when they were being trained on a treadmill. Control group patients were being trained on a treadmill without any kind of taping. Gait parameters were measured with a GAITRite$^{(R)}$ system which evaluated gait performances. Gait trainings were done for 30 min/day, 5 days/week, for 4 weeks. Results: After treadmill training, treadmill with patella taping training group showed a significant improvement in gait abilities, including velocity, cadence, paretic and non-paretic step length, and double support period (p<0.05). However, in general treadmill group, there were no significant differences in gait parameters except velocity and cadence. There was a significant difference in gait performance in the experimental group compared with the control group, except for the gait symmetry ratio (p<0.05). Conclusions: According to this result of this study, it seems that application of patellar taping in treadmill gait training for chronic stroke patients significantly improved gait abilities of these patients. Also, we can conclude that patella taping is thought to be useful in real clinical settings where there are many chronic patients who are in need of improvement in their gait abilities.

Chuna Manual Therapy for Nocturnal Crying; A Systematic Review (소아 야제에 대한 추나요법 효과; 체계적 문헌고찰)

  • Hwang, Man-Suk;Shin, Byung-Cheul;Heo, Kwang-Ho;Heo, In;Kim, Byung-Jun;Kim, Ki-Bong;Cheon, Jin-Hong;Park, Jae-Hong;Hwang, Eui-Hyoung
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.3
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    • pp.51-57
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    • 2015
  • Objectives To evaluate the evidence supporting the effectiveness of Chuna manual therapy for nocturnal crying. Methods We conducted search across the 3 electronic databases (Pubmed, CAJ and Oasis) to find all of randomized controlled clinical trials(RCTs) that used Chuna manual therapy as a treatment for nocturnal crying. The methodological quality of each RCTs was assessed using the Cochrane Risk of Bias tool and nRCTs was assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study tool. Results Two RCTs and three nRCTs met our inclusion criteria. The meta-analysis showed positive results for the use of Chuna manual therapy in terms of the efficacy rate when compared to medication treatments alone. Positive results were also obtained, in terms of the efficacy rate, when comparing Chuna manual therapy combined with acupoint application therapy to Chuna manual therapy alone, but was not statistically significant. Conclusions Our systematic review found encouraging but limited evidence of Chuna manual therapy for nocturnal crying. We recommend clinical trials which compare the effectiveness of Chuna manual therapy with usual care to obtain stronger evidence without the demerits of trial design.

Short Time Effect of Caffeine on Heart Rate Variability and the Effect of Acupuncture at Neiguan (PC6): A Randomized Double Blind Pilot Study (카페인이 HRV에 미치는 영향과 내관 자침의 효과에 대한 예비연구 : 무작위 이중맹검시험)

  • Jeong, Hyeon-Suk;Yang, Chang-Sop;Nam, Ji-Sung;Jang, In-Soo;Kim, Lak-Hyung;Seo, Eui-Seok
    • The Journal of Internal Korean Medicine
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    • v.29 no.3
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    • pp.778-786
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    • 2008
  • Objectives : This study was to investigate the short time effect of caffeine on heart rate variability(HRV) and the effect of Neiguan(PC6) acupuncture stimulation on HRV. Methods : 27 healthy adult volunteers were randomly allocated to two groups: Neiguan group (N=13) or placebo group (N=14). The study was carried out under a randomized double-blinded placebo-controlled trial method. Each group orally received the same tablets with 200 mg caffeine. After 1 hour, acupuncture was applied to the Neiguan(PC6) points for the Neiguan group, and for the placebo group was applied to a non-acupuncture point. Both groups were estimated with HRV 3 times, before and after caffeine ingestion, 20 minutes after acupuncture stimulation. Results : After taking caffeine, pulse rate, mean-HRV, and pNN50(the proportion derived by dividing NN50 by the total number of NN intervals) decreased, SDNN(standard deviation of all normal-to-normal (NN) intervals), RMSSD (the root square of successive differences), TP log, HF(high frequency), and HRV index was increased. There were significant changes to the autonomic nervous system after taking caffeine. There were no significant differences between the two groups after acupuncture at Neiguan. Conclusion : Caffeine could induce general activation of the autonomic nervous system. Neiguan acupuncture stimulation may not have significant influence on the autonomic nervous system.

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Effects of a low-FODMAP enteral formula on diarrhea on patients in the intensive care unit

  • Bae, Eunjoo;Kim, Jiyoon;Jang, Jinyoung;Kim, Junghyun;Kim, Suyeon;Chang, Youngeun;KIM, MI YEON;Jeon, Mira;Kang, Seongsuk;Lee, Jung Keun;Kim, Tae Gon
    • Nutrition Research and Practice
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    • v.15 no.6
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    • pp.703-714
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    • 2021
  • BACKGROUND/OBJECTIVES: A dietary restriction on the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) has been reported to be effective in the treatment of gastrointestinal (GI) tract complications. Enteral nutrition (EN) is widely used for patients who cannot obtain their nutritional requirements orally, but many studies have reported EN complications, especially diarrhea, in up to 50% of patients. SUBJECTS/METHODS: We performed a single-center, non-randomized, controlled trial to determine the effects of a low-FODMAP enteral formula on GI complications in patients in intensive care units (ICUs). Patients in the ICU who needed EN (n = 66) were alternately assigned to the low-FODMAP group (n = 33) or the high-FODMAP group (n = 33). RESULTS: Anthropometric and biochemical parameters were measured, and stool assessment was performed using King's Stool Chart. We excluded patients who received laxatives, GI motility agents, proton pump inhibitors, antifungal agents, and antibiotics other than β-lactams. There were no differences in GI symptoms during 7 days of intervention, including bowel sound, abdominal distension, and vomiting between the 2 groups. However, diarrhea was more frequent in the high-FODMAP group (7/33 patients) than the low-FODMAP group (1/33 patients) (P = 0.044). CONCLUSIONS: Our results suggest that a low-FODMAP enteral formula may be a practical therapeutic approach for patients who exhibit enteral formula complications. Our study warrants further randomized clinical trials and multicenter trials.

A Review of the Domestic Study Trends on Obstetrics & Gynecological Diseases with Chuna Manual Therapy (한방여성의학에서 추나요법을 활용한 국내 연구 동향 분석)

  • Lee, Jin-Wook;Hwang, Young-Sik;Kim, Gyu-Tae;Park, Seung-Hyeok;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bok;Hwang, Deok-Sang
    • The Journal of Korean Obstetrics and Gynecology
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    • v.32 no.2
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    • pp.87-99
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    • 2019
  • Objectives: The aim of this study was to analyse the domestic trends of Chuna manual therapy on Obstetrics and Gynecological Diseases in Korean literature. Methods: We searched for papers which had Chuna manual therapy through 2 related journals and 5 Korean web databases. All relevant papers were selected and extracted to be analyzed according to their study designs, academic journals, and target disease. Results: Nine papers belonged to four types of study designs, systematic review, randomized or non-randomized controlled trial and case report. And they were published in four kinds of academic journals. There were four papers about postpartum pain, two low back pain during pregnancy, and a stress urinary incontinence. The exact Chuna techniques were explained in only seven papers. All of papers have been shown that Chuna manual therapy is useful for obstetrics and gynecological diseases. Conclusions: It has been identified that Chuna manual therapy could be a good treatment for obstetrics and gynecological diseases. However, more clinical and well-designed studies with Chuna manual therapy will be needed.

Analysis on Intervention Studies of Sasang Constitutional Diet : Participant, Intervention, Comparison, and Outcome (PICO) (사상체질 식이중재연구 현황분석 : Participant, Intervention, Comparison, Outcome (PICO)를 중심으로)

  • Kim, Ji Hwan
    • Journal of Sasang Constitutional Medicine
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    • v.33 no.1
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    • pp.90-101
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    • 2021
  • Objectives The purpose of this study was to evaluate intervention studies on Sasang Constitutional diet (SCD) through the checks of Participant, Intervention, Comparison, and Outcome (PICO) Methods Randomized controlled trial (RCT) and non-randomized study for intervention (NRSI) about SCD were searched in 4 Korean core databases and other sources, and then PICO was checked. Results 1. Total 10 studies were conducted with 1 RCT and 9 NRSIs. 2. Participants were people with no specific disease, or patients with essential hypertension, hyperlipidemia, obesity, or stroke with diabetes or hyperlipidemia. Most studies were conducted on groups of various Sasang Constitutional types except Taeyangin. 3. Two studies provided participants with meals and exercise. Three studies, instead of providing meals directly, taught participants how to eat SCD on their own. 4. NRSIs have tested the effectiveness of various outcome measures without the presentation of primary outcome, and then concluded that all outcomes were ineffective or some are effective. 5. There was no mention of adverse events. In most studies, a single doctor of Korean medicine diagnosed Sasang Constitution the QSCC II questionnaire. The intervention period ranged from three weeks to three months, and recent studies have conducted interventions for 12 weeks. Conclusions Intervention studies about SCD which were conducted so far have shown problems on the study design of PICO items. The study design and implementation that carefully consider how to maintain similarity between groups, minimize the risk of bias, set primary outcome measure, and control the diet are required.

Assessment of dehydrothermally cross-linked collagen membrane for guided bone regeneration around peri-implant dehiscence defects: a randomized single-blinded clinical trial

  • Lee, Jae-Hong;Lee, Jung-Seok;Baek, Won-Sun;Lim, Hyun-Chang;Cha, Jae-Kook;Choi, Seong-Ho;Jung, Ui-Won
    • Journal of Periodontal and Implant Science
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    • v.45 no.6
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    • pp.229-237
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    • 2015
  • Purpose: The aim of this study was to determine the clinical feasibility of using dehydrothermally cross-linked collagen membrane (DCM) for bone regeneration around peri-implant dehiscence defects, and compare it with non-cross-linked native collagen membrane (NCM). Methods: Dehiscence defects were investigated in twenty-eight patients. Defect width and height were measured by periodontal probe immediately following implant placement (baseline) and 16 weeks afterward. Membrane manipulation and maintenance were clinically assessed by means of the visual analogue scale score at baseline. Changes in horizontal thickness at 1 mm, 2 mm, and 3 mm below the top of the implant platform and the average bone density were assessed by cone-beam computed tomography at 16 weeks. Degradation of membrane was histologically observed in the soft tissue around the implant prior to re-entry surgery. Results: Five defect sites (two sites in the NCM group and three sites in the DCM group) showed soft-tissue dehiscence defects and membrane exposure during the early healing period, but there were no symptoms or signs of severe complications during the experimental postoperative period. Significant clinical and radiological improvements were found in all parameters with both types of collagen membrane. Partially resorbed membrane leaflets were only observed histologically in the DCM group. Conclusions: These findings suggest that, compared with NCM, DCM has a similar clinical expediency and possesses more stable maintenance properties. Therefore, it could be used effectively in guided bone regeneration around dehiscence-type defects.

Effect of Debriefing Based on the Clinical Judgment Model on Simulation Based Learning Outcomes of End-of-Life Care for Nursing Students: A Non-Randomized Controlled Trial (임상판단모델에 근거한 디브리핑 적용이 임종간호 학습성과에 미치는 효과: 비무작위 대조시험설계)

  • Jeong, Kyung In;Choi, Ja Yun
    • Journal of Korean Academy of Nursing
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    • v.47 no.6
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    • pp.842-853
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    • 2017
  • Purpose: This study was conducted to identify effects of debriefing based on the clinical judgment model for nursing students on their knowledge, skill performance, clinical judgment, self-confidence and learner satisfaction during simulation based end-of-life care (ELC) education. Methods: Simulation based ELC education was developed in six steps as follows: selection of learning subjects and objects, development of learning tools, a trial run of simulation-based education, students' skill training, and evaluators' training. Forty-eight senior nursing students (25 in the experimental group and 23 in the control group) participated in the simulation-based ELC education using a high-fidelity simulator. Debriefing based on the clinical judgment was compared with the usual debriefing. Results: ANCOVA showed that there were differences in knowledge (F=4.81, p=.034), skill performance (F=68.33, p<.001), clinical judgment (F=18.33, p<.001) and self-confidence (F=4.85, p=.033), but no difference in satisfaction (t=-0.38, p=.704) between the experimental and control groups. Conclusion: This study found that debriefing based on the clinical judgement model is effective for supporting nursing students for reflecting on clinical judgment and improving their diverse competencies in complex clinical settings such as ELC.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Reducing Irrational Beliefs and Pain Severity in Patients Suffering from Non-Cardiac Chest Pain (NCCP): A Comparison of Relaxation Training and Metaphor Therapy

  • Bahremand, Mostafa;Moradi, Gholamreza;Saeidi, Mozhgan;Mohammadi, Samira;Komasi, Saeid
    • The Korean Journal of Pain
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    • v.28 no.2
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    • pp.88-95
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    • 2015
  • Background: Patients suffering from non-cardiac chest pain (NCCP) can interpret their chest pain wrongly despite having received a correct diagnosis. The objective of this study was to compare the efficacy of the relaxation method with metaphor therapy for reducing irrational beliefs and pain severity in patients with NCCP. Methods: Using a randomized controlled trial, 33 participants were randomly divided into a relaxation training group (n= 13), a metaphor therapy group (n = 10), and a control group (n = 10), and were studied for 4 weeks. The two tools used in this research were the Brief Pain Inventory (BPI) index for determining the degree of pain and the short version of the Jones Irrational Belief Test. Metaphor therapy and a relaxation technique based on ${\ddot{O}}$st's treatment were used as the interventions. The collected data were analyzed with a multivariate analysis of covariance (MANCOVA), a Chi-square test, and the Bonferroni procedure of post-hoc analysis. Results: The relaxation training method was significantly more effective than both metaphor therapy and the lack of treatment in reducing the patients' beliefs of hopelessness in the face of changes and emotional irresponsibility, as well as the pain severity. Metaphor therapy was not effective on any of these factors. In fact, the results did not support the effectiveness of metaphor therapy. Conclusions: Regarding the effectiveness of the relaxation method as compared with metaphor therapy and the lack of treatment in the control group, this study suggests that relaxation should be paid greater attention as a method for improving the status of patients. In addition, more studies are needed to determine the effectiveness of metaphor therapy in this area.