• Title/Summary/Keyword: Clinical Trial Protocol

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Effects of sit-to-stand imagery group training on balance performance in individuals with chronic hemiparetic stroke: a randomized control trial

  • Lee, Jeongwon;Hwang, Sujin;Ahn, Sinae
    • Physical Therapy Rehabilitation Science
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    • v.5 no.2
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    • pp.63-69
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    • 2016
  • Objective: To evaluate the effects of sit-to-stand (STS) imagery group training (IGT) on STS movement and balance performance for chronic hemiparetic stroke. Design: Randomized controlled trial. Methods: A total of 30 people with chronic hemiparetic stroke (15 for STS-IGT group and 15 for control) were recruited in this study. The STS-IGT group participated in a videotape-based STS-IGT for 30 minutes a day, five days a week for six weeks, while the control group watched a documentary on television for the same period. The STS-IGT focused on a five-stage protocol. Specifically, external imagery was used during the four phases of the STS movement from the seat of the chair to standing up. All of the participants also participated in a regular rehabilitation program. STS movement and balance performance were assessed using three clinical measures. Results: After training, time to perform the 5-repetition STS test significantly increased in the STS-IGT group (change value, $4.0{\pm}2.0$ sec) compared with the control group (change value, $0.9{\pm}0.7$ sec) (p<0.05). There was a greater improvement in Berg balance scale scores in the STS-IGT group (change value, $0.2{\pm}4.1$ points) compared with the control group (change value, $0.3{\pm}0.9$ points) (p<0.05). There was a greater improvement in Timed Up and Go scores in the STS-IGT group (change value, $2.6{\pm}1.5$ sec) compared with the control group (change value, $0.9{\pm}1.0$ sec) (p<0.05). Conclusions: STS-IGT can be considered as a useful option for restoration of STS movement and balance performance for individuals with chronic hemiparetic stroke who are unable to fully participate in physical activities.

Acupuncture for Subacute and Chronic Post-thoracotomy Pain in Patients with Traumatic Multiple Rib Fractures: A Study Protocol for a Randomised-controlled, Two-arm, Parallel Design, Pilot Trial

  • Kim, Kun Hyung;Cho, Hyun Min;Lee, Chan Kyu;Seok, JunePill;Kim, Seon Hee;Kim, Jung-Eun;Shin, Yu Kyung;Kim, Min Kyung
    • Journal of Acupuncture Research
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    • v.35 no.2
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    • pp.95-100
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    • 2018
  • Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

Advances in Radiation Oncology in New Millennium in Korea (21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전)

  • Huh, Seung-Jae;Park, Chan-Il
    • Radiation Oncology Journal
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    • v.18 no.3
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    • pp.167-176
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    • 2000
  • The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

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The Effect of Adding Kami-guibi-tang to Acetylcholinesterase Inhibitor Treatment on the Cognitive Function of Mild Alzheimer's Disease Patients: Study Protocol of a Randomized, Placebo-Controlled, Double-Blind Pilot Trial

  • Yang, Seung-bo;Kim, Ha-ri;Shin, Hee-yeon;Kim, Jeong-hwa;Lee, Chang-woo;Jahng, Geon-ho;Park, Seong-uk;Ko, Chang-nam;Park, Jung-mi
    • The Journal of Internal Korean Medicine
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    • v.41 no.3
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    • pp.326-338
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    • 2020
  • Background: Alzheimer's disease (AD) is a chronic neurodegenerative disease that causes disorientation, mood swings, problems with language, and difficulty remembering recent events. Acetylcholinesterase inhibitors (AchEIs) and memantine have been used to slow the course of the disease, but they can neither modify its progression nor prevent disease onset. Previous studies have suggested that Kami-guibi-tang (KGT) could be beneficial for supporting cognitive function in AD patients, but few clinical trials have been published. This pilot study aimed to evaluate the effect of KGT in improving cognitive function in AD patients. Methods: The study will be a randomized, placebo-controlled, double-blind, single-center trial conducted using subjects diagnosed with mild AD by neurologists. Study subjects will be randomly assigned to either a treatment or control group. The treatment group will receive KGT granules for 24 weeks, while the control group will receive placebo granules. AchEI administration will be maintained in both groups during the entirety of the study. Subjects will be assessed using the following exams: the Seoul Neuropsychologic Screening Battery (SNSB) for cognitive function; brain magnetic resonance imaging (MRI) for brain metabolite, neurotransmitter, and cerebral blood flow (CBF) measurements; the Korean version of Quality of Life-Alzheimer's Disease (KQol-AD) for quality of life; the Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI) for neurobehavioral symptoms; blood tests for amyloid and tau proteins and general blood parameters; and electrocardiography (ECG) before and after taking the medication. Discussion: Our findings will provide insight into the feasibility of large-scale trials to consolidate evidence for the efficacy of KGT for dementia treatment. Registration ID in CRIS: KCT0002904 (Clinical Research Information Service of the Republic of Korea).

Randomized, Double-blind, and Placebo-controlled a Human Study for Growing of Stature via the Analysis of Effect of Ferment Oyster Extract: Study Protocol (발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜)

  • Kim, Hee-Yeon;Park, Beom-Chan;Cheon, Jin-Hong;Choi, Jun-Yong;An, Byeong-Min;Park, Joung-Hyun;Lee, Bae-Jin;Kim, Kibong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.4
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    • pp.37-46
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    • 2019
  • Objectives The purpose of this study is to confirm the efficacy and safety of the treatment of with fermented oyster extract on height growth in children with short stature. Methods A total of 100 people, between 6 and 11 years old, will be participated in a randomized, double-blind, and placebo-controlled human study. The fermented oyster group will take 500 mg of fermented oyster extract once a day for 24 weeks. The placebo group will take 3400 mg of fructooligosaccharide as placebo once a day for 24 weeks. The outcomes of the intervention will be measured at the baseline, 6 week, 12 week, 18 week, and 24 week. The primary outcome is the changes in height from the baseline. The secondary outcomes are growth rate, height SDS, bone age, GH, IGF-1, IGFBP-3, osteocalcin, BALP, DPD, and LH. Results This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB-2019002). Recruitment of the research participants will be opened from May 2019 till December 2019. Conclusions This study will provide clinical information to determine the efficacy and safety of the treatment with fermented oyster extract on height growth in children with short stature.

Review of the Latest Oriental and Traditional Clinical Articles and Protocol about Male Sexual Dysfunction (남성 성기능장애 관련 한의학 및 전통의학 임상 연구 동향 분석과 프로토콜 분석)

  • Park, Dong-Su;Park, Sun Young;Shin, Seon Mi
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.27 no.5
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    • pp.530-539
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    • 2013
  • This study reviews the latest articles about oriental and traditional medicine treatment of male sexual dysfunction. We searched the article from 2000 to 2012 using 5 data bases. There were no restrictions on the type of publication, but articles not available in full text were excluded. The methological quality of RCT study was assessed according to Jadad scores and Cochrane's assessment of risk of bias. 18 articles were included in this study. 5 articles published in Korea, the rest were foreign articles. 9 articles were randomized controlled trial(RCT), Case-control studies were 3, case reports were 3, One group pre-post test were 3. In RCT studies, Jadad scores were generally low, and risk of selection bias and performance bias were generally high, risk of detection bias was unclear. Oriental and traditional medicine treatment is as effective as western medicine treatment for male sexual dysfunction, more rigorous oriental medicine treatment studies should be warranted.

Manual Therapy in the Treatment of Temporomandibular Disorders: A Protocol for a Systematic Review (측두하악 장애 치료를 위한 수기치료에 대한 체계적 고찰의 프로토콜)

  • Kim, Hyungsuk;Jung, Jae-Young;Chung, Seok-Hee
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.41-46
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    • 2015
  • Objectives This systematic review will analyse randomised controlled trials (RCTs) of manual therapy in patients with temporomandibular disorders (TMDs) to evaluate the efficacy of this approach. Methods RCTs will be identified in the following ten databases based on searches starting with their inception: MEDLINE, EMBASE, CENTRAL, four Korean databases as KoreaMed, DBPIA, NDSL, and RISS and three Chinese databases as CNKI, VIP and Wanfang. The quality of these studies will be analysed using the Cochrane risk of bias. A meta-analysis will be conducted, and subgroup analysis will be considered if comparatively large heterogeneity is detected. Conclusions We plan to publish this systematic review in a peer-reviewed journal. Findings from this review may contribute to the treatment process in clinical situations. Trial registration number: PROSPERO 2015: CRD42015024090

Current Update on Transcranial Direct Current Stimulation as Treatment for Major Depressive Disorder (주요우울장애의 치료로서 경두개 직류자극술(Transcranial Direct Current Stimulation)의 현재)

  • Lee, Seung-Hoon;Kim, Yong-Ku
    • Korean Journal of Biological Psychiatry
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    • v.25 no.4
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    • pp.89-100
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    • 2018
  • Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that delivers 1-2 mA of current to the scalp. Several clinical studies have been conducted to confirm the therapeutic effect of major depressive disorder (MDD) patients with tDCS. Some studies have shown tDCS's antidepressant effect, while the others showed conflicting results in antidepressant effects. Our aim of this review is to understand the biological bases of tDCS's antidepressant effect and review the results of studies on tDCS's antidepressant effect. For the review and search process of MDD treatment using tDCS, the US National Library of Medicine search engine PubMed was used. In this review, we discuss the biological mechanism of tDCS's antidepressant effect and the existing published literature including meta-analysis, systematic review, control trial, open studies, and case reports of antidepressant effects and cognitive function improvement in patients with MDD are reviewed. We also discuss the appropriate tDCS protocol for MDD patients, factors predictive of response to tDCS treatment, the disadvantages of tDCS in MDD treatment, and side effects.

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Influence of successive active knee extension tests on hamstring flexibility (연속적 능동무릎폄 검사가 뒤넙다리근의 유연성에 미치는 영향)

  • Lim, Woo Taek
    • Journal of Korean Physical Therapy Science
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    • v.28 no.1
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    • pp.76-84
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    • 2021
  • Background: In clinical practice, active knee extension (AKE) test has been widely used to measure hamstring flexibility. During the AKE test, the knee extension is repeated six times. The first five repetitions are considered as warm-up, and the sixth is used as baseline. In order to accurately measure the subject's inherent flexibility, warm-up trials have been proposed as mentioned above; but currently, the evidence is insufficient. Design: Cross-sectional study. Methods: Forty-three healthy adults participated in this study. The AKE was performed slowly after flexing the hip and knee joints by 90° in a supine position. The knee was extended as far as could be done without causing discomfort or pain. When reaching the end range, knee flexion was performed without stopping. As per standard protocol, the subjects performed the knee extension six times. Results: There was no significant difference between the AKE value in the first trial with those in the other five trials. During the repetitions, the average value in the group with higher flexibility tended to decrease and the Intraclass correlation coefficient gradually decreased. Conclusion: Successive repetitions of the AKE test can misrepresent an individual's inherent hamstring flexibility. In order to avoid a decrease in hamstring flexibility, it is strongly recommended that individuals with high initial hamstring flexibility avoid unnecessary repetitions of the AKE test.

Report of the 3rd Japan-Korea Workshop on Acupuncture and EBM;Protocol development for the acupuncture trial on the osteoarthritis of the knee

  • Jang, Jun-Hyouk;Kenji, Kawakita;Hahn, Seo-Kyung;Park, Hi-Joon;Lee, Seung-Deok;Kim, Yong-Suk;Norihito, Takahashi;Toshiyuki, Shichidou;Kazunori, Itoh;Eiji, Sumiya;Eiji, Furuya;Hitoshi, Yamashita;Hiroshi, Tsukayama
    • Journal of Acupuncture Research
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    • v.23 no.6
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    • pp.239-254
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    • 2006
  • The 3rd Japan-Korea Workshop on Acupuncture and EBM was held at Kanazawa on June $16^{th}$. From Korea team, 4 papers were presented. Dr. Hahn introduced a new approach of data analysis on series of n-of-1 trials using the Bayesian statistics. It offered important information for the future n-of-1 trials. Dr. Park clearly demonstrated the significance of various sham devices proposed and stressed the importance of research questions when we choose the control intervention in RCT. Dr. Lee reported the results of survey in Korean Medical Doctors (KMD) for their point selection and techniques to the distal and local points. Dr. Kim presented the results of face to face survey on the KMD with 28 items for acupuncture treatment on the knee OA. Finally, a draft of protocol was introduced by Dr. Kim. The title was "multi-center, a randomized, single blinded, two arms, parallel-group study to compare the effectiveness and safety of 'individualized acupuncture' and 'standardized minimal acupuncture' in Korean and Japanese patients with knee osteoarthritis (Phase IV)". From Japan team, 7 speakers presented their comments and proposals on the protocol. Dr. Takahashi introduced several issues regarding n-of-1 trials and pointed out the importance of obtaining generalizability from n-of-1 trials. Dr. Shichidou pointed the importance of research design, selection of outcome measures and reduction of biases. Dr. Itoh presented the results of point selection for the knee OA based on the literature survey. Dr. Sumiya introduced several differences between KMD and Japanese acupuncturists based on the questionnaire used in KMD survey. Dr. Furuya demonstrated a result of press tack needle and its sham device on shoulder stiffness. Dr. Yamashita introduced the results of literature survey regarding adverse events occurred by acupuncture on knee OA. Dr.Tsukayama stressed the importance of responsibility of Institutional Review Board (IRB) for the conduction of clinical trials. After several issues were discussed, the need of continued meeting for final protocol development was agreed, then the workshop was closed.

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