• Title/Summary/Keyword: Pilot trial

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The effects of treadmill training on dynamic balance and gait function in stroke patients: a pilot randomized controlled trial

  • Chung, Eun Jung;Lee, Byounghee
    • Physical Therapy Rehabilitation Science
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    • v.2 no.1
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    • pp.39-43
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    • 2013
  • Objective: The objective of this study is to investigate the effect of treadmill gait trainig on dynamic balance and gait functions in stroke patients. Design: Randomized, double-blind, controlled pilot study. Methods: Four subjects following first stroke participated in this study. They were divided randomly into the treadmill gait trainig group (TM group) (n=2) and the control group (n=2). Subjects in both groups received general training five times per week. Subjects in the TM group practiced an additional treadmill gait trainig program that consisted of 60 minutes, three times per week, during a period of four weeks. Timed up and go test (dynamic balance) and the GAITRite test (gait function) were evaluated before and after the intervention. Results: In dynamic balance (timed up and go test), the TM group (-14.235 sec) showed a greater decrease than the control group (-13.585 sec). In gait functions, the TM group showed a greater increase in gait speed (12.8 cm/s vs. 10.15 cm/s), step-length (5.825 cm vs. 3.735 cm), and stride-length (5.005 cm vs. 1.55 cm) than the control group. Conclusions: The treadmill gait trainig improved dynamic balance and gait functions. Further research is needed in order to confirm the generalization of these findings and to identify which stroke patients might benefit from treadmill gait trainig.

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A Clinical Study of Electroacupuncture and Auricular Acupuncture for Abdominal Pain Relief in Patients with Pancreatitis: A Pilot Study (췌장염 환자의 복통 호전을 위한 전침 및 이침 치료 예비 임상연구 프로토콜)

  • Kang, Ha Ra;Lee, Yeon Sun;Kim, Hye Ryeon;Kim, Eun Jung;Kim, Kyung Ho;Kim, Kap Sung;Jung, Chan Yung;Lee, Jun Kyu
    • Korean Journal of Acupuncture
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    • v.34 no.1
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    • pp.47-55
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    • 2017
  • Objectives : The purpose of this study is to evaluate the feasibility of further acupuncture research as an effective alternative and safe treatment for abdominal pain control in patients with pancreatitis. Methods and Results : This study is an open-label, assessment-blind, parallel designed pilot clinical trial. Thirty participants will be assigned to the acupuncture group(n=15) and usual care group(n=15). All patients will receive the conventional standard-of-care(SOC) therapy, but only the experimental group will receive acupuncture therapy six times a week, and the duration of acupuncture therapy will be held up to 12 weeks or until the pains are to be resolved. For the conventional SOC therapy, painkiller will be given. In treatment group, the subjects will receive the identical SOC therapy in combination with electroacupuncture therapy on twelve acupuncture points(LI4, PC6, SP6, GB39, ST36, ST37), and auricular acupuncture therapy on five auricular acupuncture points(Sympathetic, Shen Men, Abdomen, Pancreas gall, and Spleen). The primary outcome will be measured using the visual analogue scale(VAS), and the secondary outcome will be measured using the painkiller demand, quality of life index and severity of pancreatitis by abdominal computed tomography(CT). Assessments will be made at baseline and at week 1, 4, 8 and 12. Results of abdominal CT will be evaluated at baseline and at week 12. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for abdominal pain in patients with pancreatitis.

Case Report of Efficacy and Safety of Long Term Medication of Oncheongeum-gamibang (온청음 가미방 3개월간 장기복용의 유효성과 안전성 보고)

  • Lee, Sang Young;Kang, Hwi Joong;Jung, Min Young
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.27 no.2
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    • pp.268-272
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    • 2013
  • This study is designed as pilot study to report the efficacy and safety of long term medication of Oncheongeum-gamibang on atopic dermatitis. The patient of atopic dermatitis was asked to take Oncheongeum-gamibang for 3 months. Every end of month, he had gotten hematological test and SCORAD Index examination. After the clinical trial was done, he had additional examination to see the changes and duration of medicinal effect. During the period of taking Onchung-um, estimation of symptoms by SCORAD Index examination showed little bit of improvement while taking medicine and after one month, the improvement was maintained. There were no significant changes in hematologic test and liver function test during and at the end of the clinical trial. We were able to find out that it is effective and safe to take long term medication of Oncheongeum-gamibang for an individual. However, due to deficiency of the cases and immunological values, there will be additional study to make up for better result.

Effect of a Randomized Controlled Trial Walking Program on Walking, Stress, Depressive Symptoms and Cardiovascular Biomarkers in Elderly Korean Immigrants

  • Sin, Mo-Kyung;Ibarra, Brandon;Tae, Thomas;Murphy, Patrick J.M.
    • Journal of Korean Biological Nursing Science
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    • v.17 no.2
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    • pp.89-96
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    • 2015
  • Purpose: Despite well-known benefits of walking on cardiovascular health, no structured walking exercise program has been formally tested on elderly Korean immigrants (EKIs). This pilot randomized controlled trial study assessed the effect of a walking program on walking behavior (pedometer steps count), stress (cortisol), depressive symptoms (CESD-10), and cardiovascular disease biomarkers (hs-CRP and fibrinogen) via venipuncture in EKIs. Methods: Seventy EKIs recruited from a Korean community were randomly assigned to a 12-week walking group or control group in a 3:2 ratio. The working program included a pedometer, buddy, monthly coffee card, weekly call for goal setting, and physical activity consultation. Walking group EKIs maintained the Centers for Disease Control and Prevention recommended exercise guidelines and good mental health status over 12 weeks. Results: There was no significant difference in the outcomes between control and walking groups. Conclusion: Social networking with Koreans in the senior center and church from a well-established Korean community might have positive effects on mental health.

Analysis of the Effectiveness of Tai Chi Exercise in Elderly (노인에게 적용한 타이치운동의 논문분석)

  • Lee, Hea-Young;Kim, Kum-Ja
    • Journal of muscle and joint health
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    • v.15 no.1
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    • pp.5-23
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    • 2008
  • Purpose: This study aims to conduct a systematic review of the physical, psychosocial and physiological effects of Tai Chi exercise in elderly. Method: 37 articles from Medline search of foreign journals (1966-2006) were surveyed by the key words 'Tai Chi', 'Tai-chi program' and 'Tai-chi and elderly' limiting the range to age 65 or older, choosing clinical trial and randomized controlled trial research in English articles. Four articles were excluded due to methodological study, pilot study and review. The research was analyzed according to health status of the subjects, styles and forms of Tai Chi exercises, factors for physical, psychosocial and physiological measures. Result: A short forming Yang style was commonly used in chronic diseases and health for elderly. Variable outcome measures were used in Tai Chi studies relating to balance, muscle strength, walking and mobility, flexibility and cardiorespiratory function in physical measure, quality of life, depression, self-efficacy, health status, cognition and impact questionnaire in psychosocial measure, lipids, insulin resistance and hormone in physiological measure. Conclusion: Tai Chi exercise appears to have physical and psychosocial benefits and also appears to be safe for elderly and chronic diseases. It is suggested that future studies analyze statistical part of systematic reviews through meta analysis.

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Physician-staffed Helicopter Transport for Mountain-rescued Emergency Patients: a Pilot Trial (의사 탑승 헬기를 이용한 산악 응급 환자 이송: 시범 연구)

  • Park, Jeong Ho;Shin, Sang Do;Lee, Eui Jung;Park, Chang Bae;Lee, Yu Jin;Kim, Kyoung Soo;Park, Myoung Hee;Kim, Han Bum;Kim, Do Kyun;Kwon, Woon Yong;Kwak, Young Ho;Suh, Gil Joon
    • Journal of Trauma and Injury
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    • v.25 no.4
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    • pp.230-240
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    • 2012
  • Purpose: We aimed to compare the transport time, the proportion of direct hospital visit and the emergency procedures between the current mountain rescue helicopter emergency medical service (HEMS) and physician-staffed mountain-rescue HEMS. Methods: During weekends from October 2, to November 21, 2010, 9 emergency physicians participated as HEMS staff in the mountain-rescue HEMS program of the Seoul fire department. Patient demographic data, transport time, proportion of direct hospital visits, and emergency procedures were recorded. We also collected data on HEMS mountain-rescued patients from June 1, to September 1, 2010, and we compared them to those for the study patients. After an eight-week trial of the HEMS, we performed a delphi survey to determine the attitude of the physician staff, as well as the feasibility of using a physician staff. Results: Twenty-four(24) patients were rescued from mountains by physician-staffed HEMS during the study period, and 35 patients were rescued during the pre-study period. Patient demographic findings were not statistically different between the two groups, but the transport time and the emergency procedures were. During the study period, the time from call to take-off was $6.1{\pm}4.1min$ (vs. $12.1{\pm}8.9min$ during the pre-study period, p-value=0.001), and the time from call to arrival at the scene was $15.0{\pm}4.8min$ (vs. $22.3{\pm}8.1min$ during the pre-study period, p-value=0.0001). The proportions of direct hospital visit were not different between the two groups, but more aggressive emergency procedures were implemented in the study group. The delphi survey showed positive agreement on indications for HEMS, rapidity of transport and overall satisfaction. Conclusion: A pilot trial of physician-staffed HEMS for mountain rescue showed rapid response and more aggressive performance of emergency procedures with high satisfaction among the attending physicians.

Efficacy and Safety of Miniscalpel Acupuncture on Knee Osteoarthritis - A randomized controlled pilot trial -

  • Jun, Seungah;Lee, Jung Hee;Gong, Han Mi;Choi, Seong Hun;Bo, Min Hwang;Kang, Mi Suk;Lee, Geon-Mok;Lee, Hyun-Jong;Kim, Jae Soo
    • Journal of Pharmacopuncture
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    • v.21 no.3
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    • pp.151-158
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    • 2018
  • Objectives: We investigated the efficacy and safety of miniscalpel acupuncture (MA) for knee osteoarthritis (KOA) in an assessor-blinded randomized controlled pilot trial; this would provide information for a large-scale randomized controlled trial. Methods: Participants (n = 24) were recruited and randomly allocated to the MA group (experimental) or acupuncture group (control). The MA group received treatment once a week for 3 weeks (total of 3 treatments), while the acupuncture group received treatment two times per week for 3 weeks (total of 6 treatments). The primary outcome was pain as assessed by a visual analogue scale (VAS). The secondary outcomes (intensity of current pain, stiffness, and physical function) were assessed using the short-form McGill Pain Questionnaire (SF-MPQ) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Assessments were performed at baseline, 1, 2, and 3 during treatment and at week 5 (2 weeks after the end of treatment). Results: Of the 24 participants, 23 completed the study. Both groups showed significant improvements in VAS, SF-MPQ, and WOMAC. However, there were no significant differences between the MA and acupuncture groups. No serious adverse event occurred and blood test results were within normal limits. Conclusion: Our results suggest that although both MA and acupuncture provide similar effects with regard to pain control in patients with KOA, MA may be more effective in providing pain relief because the same relief was obtained with fewer treatments. A large-scale clinical study is warranted to further clarify these findings.

Investigation of changes in abdominal cavity between dyspepsia patients and healthy participants when pressure pain occurs using an algometer combined with an ultrasound device: a non-randomized, controlled, pilot trial (초음파 결합형 압통계를 활용한 압통시 소화불량 환자와 건강인의 복강내 조직 변화 비교: 비무작위 대조군 예비 임상시험)

  • Jinwoong Lim;Taeseong Jeong;Hoseok Jung;Sunny Kang;Chang-Min Choi;Dong Woung Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.27 no.1
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    • pp.43-52
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    • 2023
  • Objectives : The aim of this study was to evaluate the differences in the abdominal cavity between functional dyspepsia patients and healthy people using an algometer combined with an ultrasound device. Methods : A non-randomized, controlled, pilot trial was conducted. Thirty patients in the experimental group and fifteen participants in the control group were recruited. We collected demographical data, and measured abdominal circumference, height of the body cavity, subcutaneous fat thickness, visual analogue scale of dyspepsia symptoms in the experimental group, depth of algometer and pressure of algometer when pressure pain occurred, and the whole ultrasonic image from the beginning of pressurization to the time when pressure pain occurred. The measurements were carried out twice with the duration of 1 week. Generalized linear regression was conducted to adjust baseline characteristics. Results : A total of 45 participants (30 in experimental group, 15 in control group) were recruited and finished the trial. Females were recruited more in the experimental group than in the control group and it was statistically significant. The difference in thickness of abdominal cavity between a second before the pressure pain and at the time when pressure pain occurred was statistically significant on 1st visit, and other measurements were not statistically significant. From the results of the regression analysis, the difference between two groups was statistically significant in the differences in the thickness of stomach and up to abdominal aorta on 1st visit, and the thickness of stomach on 2nd visit, and other measurements were not statistically different. Conclusions : According to the results, there were not statistically significant differences in abdominal examination when pressure pain occurred between dyspepsia patients and healthy people. Further studies are warranted to assess the abdominal examination using devices including algometer and ultrasound devices, regarding the results of the present study.

The Effects of Tai Chi for Arthritis on Chronic Arthritic Pain of Senior Female : A Pilot Study (만성 관절 통증 여성 노인환자에 있어 관절염 태극권의 효과에 대한 pilot study)

  • Hwang, Eui-Hyoung;Kim, Jung-Hwan;Jang, In-Soo;Yang, Chang-Sop;Kang, Jun-Won
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.1
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    • pp.79-90
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    • 2010
  • Objectives : Tai Chi for arthritis was developed in 1997 by Paul Lam, M.D. of family medicine in Australia. It is an exercise treatment program and a good approaching method for arthritis. However its application is limited to arthritis of knee joint only. Even there have been no clinical study in korean traditional medical society. The aim of this study is to investigate effect of the Tai Chi for arthritis on chronic pain of body. Methods : We designed this trial as objectives were (1) senior female over 60 years, (2) suffering for osteoarthritis and chronic body pain, (3) have no physical or mental dysfunctions (4) able to walk and exercise alone. Objectives mactched these criteria had been trained the Tai Chi for arthritis 2 hours a day for 21 weeks. Before and after training, pain of 8 joints (neck, shoulder, elbow, wrist, waist, hip, knee, ankle) were estimated with the VAS(Visual Analog Scale). Results : Training the Tai Chi for arthritis relieved multiple joint pain(especially neck, lower back, shoulder, wrist and knee) and these were statistically significant. Conclusions : This study is a pilot study to investigate effect of the Tai Chi for arthritis on chronic pain of whole body. Absence of control group, and other scale to test joint function except VAS were limitations of this study. It is the first clinical approach about Tai Chi in korean medicine field, also the first study of Tai Chi for pain of the whole body.

A Novel Implantable Cerebrospinal Fluid Reservoir : A Pilot Study

  • Byun, Yoon Hwan;Gwak, Ho Shin;Kwon, Ji-Woong;Kim, Kwang Gi;Shin, Sang Hoon;Lee, Seung Hoon;Yoo, Heon
    • Journal of Korean Neurosurgical Society
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    • v.61 no.5
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    • pp.640-644
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    • 2018
  • Objective : The purpose of this pilot study was to examine the safety and function of the newly developed cerebrospinal fluid (CSF) reservoir called the V-Port. Methods : The newly developed V-Port consists of a non-collapsible reservoir outlined with a titanium cage and a connector for the ventricular catheter to be assembled. It is designed to be better palpated and more durable to multiple punctures than the Ommaya reservoir. A total of nine patients diagnosed with leptomeningeal carcinomatosis were selected for V-Port insertion. Each patient was followed up for evaluation for a month after the operation. Results : The average operation time for V-Port insertion was 42 minutes and the average incision size was 6.6 cm. The surgical technique of V-Port insertion was found to be intuitive by all neurosurgeons who participated in the pilot study. There was no obstruction or leakage of the V-Port during intrathecal chemotherapy or CSF drainage. Also, there were no complications including post-operative intracerebral hemorrhage, infection and skin problems related to the V-Port. Conclusion : V-Port is a safe and an easy to use implantable CSF reservoir that addresses problems of other implantable CSF reservoirs. Further multicenter clinical trial is needed to prove the safety and the function of the V-Port.